Skip Hop Recalls Baby Sesame Street Elmo Silicone Teethers Due to Risk of Serious Injury…
The William Carter, of Atlanta, Georgia
Updated 2 days agoAbout 22,660 (In addition, abou… units
The black eyes can detach from the recalled teether if frozen, posing a risk of serious injury or death from a choking hazard.
Hazard. The black eyes can detach from the recalled teether if frozen, posing a risk of serious injury or death from a choking hazard.
What to do
Consumers should stop using the recalled teether immediately, take it away from children and contact Skip Hop Inc. at www.skiphoprecall.com to obtain a refund in the form of a gift card and further instructions on disposal of the product
The gift card can be used at any The William Carter Company …
Daikin Comfort Technologies Manufacturing Recalls Amana Through-The-Wall Air Conditioners…
Daikin Comfort Technologies Manufacturing, of Houston, Texas
Updated 2 days agoAbout 4,633 (In addition, about… units
The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
Hazard. The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
What to do
Consumers should stop using the recalled product immediately and contact Daikin Comfort Technologies Manufacturing, Inc. (DCT) to submit a request for a full refund of the unit
Consumers will be required to provide their contact information, cut the product’s cord, and then upload a photo of the…
Branch Recalls Ergonomic Chairs Due to Fall Hazard
Branch
Updated 2 days agoAbout 16,000 (In addition, abou… units
The backrests of the chairs can detach, posing a fall hazard to consumers.
Hazard. The backrests of the chairs can detach, posing a fall hazard to consumers.
What to do
Consumers should stop using the recalled chairs immediately and contact Branch for a free repair kit consisting of a replacement backrest, installation instructions, three bolts and an Allen key
Consumers will be provided with instructions on how to determine if their backrests are included in the…
MONDRAKER USA Recalls Mountain Bicycles Equipped with ONOFF S9 Carbon MTB Handlebars Due…
MONDRAKER USA, of Boulder, Colorado
Updated 2 days agoAbout 177 (In addition, about 5… units
The affected handlebars may crack or fracture during use, which can lead to loss of control, posing a risk of serious injury or death from …
Hazard. The affected handlebars may crack or fracture during use, which can lead to loss of control, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using affected bicycles immediately and verify whether their bicycle is affected using the serial number verification tool available at: https://mondraker.com/wo/en/recall-s9
If the bicycle is identified as affected, consumers should contact an authorized Mondraker dealer to …
Walmart Reannounces Recall of Mainstays Nine-Drawer Fabric Dressers Due to Risk of…
Hop Thang Interior Wood (Vietnam)
Updated Aug 27About 165,250 (About 165,000 of… units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of …
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers if they are not anchored to the wall immediately, place them in an area that children cannot access and contact Walmart for a full refund
Consumers will be asked to return the dressers’ drawers to any Walmart store and dispose of the dressers’ …
Workbless Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and…
Amazon.com, BestBuy, Kohls, Lowe's, Overstock, Target and Walmart from April 2025 through July 2026 for between $97 and…
Updated Aug 20About 2,200 (In addition, about… units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious ri…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Workbless for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to [email protected]
KTM North America Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death…
KTM North America, of Amherst, Ohio
Updated Aug 20About 21,040 (In addition, abou… units
The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash…
Hazard. The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash hazard.
What to do. Consumers should stop riding the recalled motorcycles immediately and contact an authorized GASGAS or Husqvarna Motorcycle dealer to schedule a free repair at the dealership.
Yamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death…
Yongkang Dingchang Industry and Trade (China)
Updated Aug 13About 1,050 (Yamazuki vehicles … units
The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting…
Hazard. The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting device is not set to the restricted speed required for children ages six (6) and older, posing a crash hazard. Additionally, the ATVs are missing the required rear safety reflectors, reducing visibility of the youth ATV to other vehicles, posing a deadly cras…
What to do
Consumers should stop using the recalled youth ATVs immediately and contact Yamazuki for a free repair kit, including shipping
The repair kit consists of replacement parking brake latches, rear safety reflectors, an owner's manual storage bag and repair tools
Taleco Gear Recalls Baby Jumpers, Baby Swings and 2-in-1 Baby Jumper & Swings Due to Risk…
Tale Gear, of La Verne, California
Updated Aug 13About 41,100 (In addition, 150 … units
The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging r…
Hazard. The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging restraint straps and seat openings can pose strangulation hazards.
What to do
Consumers should stop using the recalled products immediately and contact Taleco Gear to receive a full refund
Consumers will be provided with instructions on how to destroy the recalled products and provide photos of the destroyed parts to obtain a full refund
Goody King Magnetic Building Cubes and Blocks Recalled Due to Risk of Serious Injury or…
Yi Suen Commerce (Hong Kong)
Updated Aug 13About 213,500 units
The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to …
Hazard. The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and…
What to do
Consumers should stop using the recalled magnetic building cubes immediately and contact Yi Suen Commerce for a full refund
Consumers will be provided with a pre-paid label to return the recalled magnetic cubes to receive a refund
OKK Trading Recalls Rainbow Mystery Squishy Bun Toys Due to Risk of Serious Injury or…
OKK Trading, of Vernon, CA
Updated 2 days agoAbout 7,200 units
The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitt…
Hazard. The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
What to do
Consumers should stop using the squishy dumpling toys immediately and contact OKK Trading for a full refund
Consumers will be asked to write “RECALLED” in permanent marker on the squeezy dumpling and its tan plastic container, throw the toy away, and email a photo of the disposed toy to recall…
Gizoon Direct Recalls Six-Drawer Double Dressers Due to Risk of Serious Injury or Death…
Gizoon Direct
Updated 2 days agoAbout 4,396 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Gizoon Direct for a full refund
Consumers will be asked to write in permanent marker "RECALLED" on the top and all sides of the dresser …
GIHNJSI Squeezy Dumplings Toys Recalled Due to Serious Ingestion, Choking and Obstruction…
Chenyuanhui (China)
Updated 2 days agoAbout 8,000 units
The squeezy toys contain water beads. If ingested, water beads expand and can pose deadly ingestion, choking, and intestinal obstruction ha…
Hazard. The squeezy toys contain water beads. If ingested, water beads expand and can pose deadly ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration, and a risk of death to a child.
What to do
Consumers should stop using the Squeezy Dumplings toys immediately and contact Chenyuanhui for a full refund
Consumers will be asked to write “RECALLED” in permanent marker on the Squeezy Dumpling and on its tan plastic container, throw the toy away and email a photo of the disposed toy to GIH…
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
Fangzhou Overseas Consulting Shenzhen, doing business as Loyoda Direct (China)
Updated 2 days agoAbout 2,200 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails also do not meet retention strap requirements, posing a fall hazard. The bed rails’ push pins and push pin holes are …
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact Loyoda for a full refund
Consumers will be asked to cut the black safety strap in half and write “RECALLED” on the upper and lower bed rails with a permanent marker, take a photo of the marked bed rail an…
Cooluli Recalls 10-Liter and 15-Liter Minifridges Due to Fire and Burn Hazards
Ningbo Iceberg Electronic Appliance (China)
Updated Aug 13About 250,000 units
The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.
Hazard. The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.
What to do
Consumers should stop using the recalled minifridges immediately and contact Cooluli for a free replacement power cord
Consumers will be asked to visit www.cooluli.com/pages/product-notices-recalls to enter the model and batch numbers to determine whether their minifridge is included in the recall…
SHEIN Distribution Corporation Recalls Spiral Toys Due to Risk of Serious Injury or Death…
SHEIN Distribution of Los Angeles, California
Updated 2 days agoAbout 963 units
The toys violate the small ball ban because they contain small balls and are intended for children under three years of age, posing a deadl…
Hazard. The toys violate the small ball ban because they contain small balls and are intended for children under three years of age, posing a deadly choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact SHEIN for a full refund
Consumers will be asked to affirm they disposed of the entire toy, including the small balls
Nanjing Wu Hai Smart Home Appliance Store Recalls Alanca 6-Drawer Dressers Due to Risk of…
Nanjing Wu Hai Smart Home Appliance Store (China)
Updated 2 days agoAbout 261 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Nanjing Wu Hai Smart Home for full refund
Consumers will be asked to write in permanent marker “RECALLED” on the top, front and side…
Montessori Baby Toy Sets Recalled Due to Risk of Serious Injury or Death from Choking…
Chillife Official
Updated Aug 27About 20,134 units
The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings ar…
Hazard. The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can reach the back of children’s throat and become lodged, posing a risk of respiratory distress and deadly choking hazard.
What to do
Consumers should stop using the pull string teether toys immediately, take them away from children and contact Chillife Official for a partial refund of $5.40
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker “DESTROYED” on the main body…
Diamond Wipes International Recalls MD Wipe Outz Numbing Tattoo Wipes Due to Risk of…
Diamond Wipes International, of Chino, California
Updated Aug 27About 55,250 units
The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Ac…
Hazard. The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.
What to do
Consumers should secure the wipes out of sight and reach of children immediately and contact Diamond Wipes for a full refund
Consumers will be asked to write “RECALLED” on the packet and send a photo of the marked packet to [email protected]
TooyBing Wooden Bead Stacking Toys Recalled Due to Risk of Serious Injury or Death from…
Guangzhou Yide Toys (China)
Updated Aug 13About 21,758 units
The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a dead…
Hazard. The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a deadly choking hazard to young children.
What to do
Consumers should stop using the toys immediately, take them away from children, and contact TooyBing for free replacement
Consumers will be asked to destroy the toys by cutting the red and yellow string laces, writing in permanent marker "RECALLED" on the top of the wooden pegged stand and send a …
Southern Telecom Recalls Brookstone-Branded Tabletop Fire Pits Due to Risk of Serious…
Southern Telecom, of Brooklyn, New York
Updated Aug 13About 48,700 units
Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as fl…
Hazard. Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as flame jetting from fuel containers, resulting in serious or fatal burns.
What to do
Consumers should stop using the Brookstone-branded Tabletop Fire Pits immediately and contact Southern Telecom to receive a full refund
Consumers can email a photo of the fire pit with "Recalled," their name, and the date written on it in permanent marker to [email protected] and then…
Winston Porter and Seeday 3-Drawer, 4-Drawer, and 5-Drawer Dressers Recalled Due to Risk…
The 3-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $110. The 4-Drawer Dresser w…
Updated Aug 6About 2,000 5-Drawer Dressers, … units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Consumers should contact Linyi Lingmoxuan and Seeday for instructions on how to identify affected units and dispose of the dressers to receive a …
Recall of Cpzzkq Baby Loungers Expanded Due to Risk Serious Injury or Death from…
Online at Amazon.com from May 2026 through June 2026 for between $30 to $50.
Updated Jul 30About 2,195 (CetoPMax previousl… units
The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's b…
Hazard. The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
What to do
Consumers should stop using the baby loungers immediately and contact CetoPMax for a refund
Consumers will be asked to remove the foam and pad from the baby lounger's cover and cut the cover, foam and pad in half
Consumers should then email photos of the destroyed pieces to CetoPMaxRecall@outlook…
Heated Sherpa Throws and Blankets Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2021 through December 2025 for between $40 and $60.
Updated Jul 30About 178,000 units
The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and…
Hazard. The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and shock hazards.
What to do
Consumers should stop using the recalled throws and blankets immediately and contact OCTROT for a full refund
Consumers will be asked to destroy the throws and blankets by unplugging the electrical cord and cutting it in half, and to send a photo of the destroyed product, showing the cut electrica…
Galanz Americas Recalls Retro Refrigerators Due to Risk of Serious Injury or Death from…
Zhongshan Galanz (China)
Updated Jul 30About 121,680 units
The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire…
Hazard. The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do. Consumers should unplug and stop using the recalled refrigerators immediately until repaired and contact Galanz to schedule free in-home repair by a qualified technician.
BenQ America Recalls GV31 Portable Projectors Due to Risk of Serious Injury or Death from…
BenQ America, of Costa Mesa, California
Updated Jul 30About 1,249 (In addition, about… units
The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards.
Hazard. The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the projectors immediately and contact BenQ for a free battery repair or replacement projector, including shipping
Consumers will be asked to register at https://www.benq.com/en-us/support/gv31recall.html and receive a prepaid label and package to return the recalled pr…
Huish Outdoors Recalls Hollis Diving Regulators Due to Risk of Serious Injury or Death…
Huish Outdoors, of Salt Lake City, Utah
Updated Jul 16About 7,200 (In addition, about… units
The regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.
Hazard. The regulator inlet tube can crack and break, posing a risk of serious injury or death from drowning.
What to do
Consumers should stop using the recalled diving regulators immediately and return their regulator to the nearest authorized Hollis dealer for a free repair
Consumers can visit www.hollis.com/dealer-locator/ to find their nearest authorized Hollis dealer
Southern Telecom Expands Recall of Lomi Waxing Kits Due to Risk of Serious Injury or…
Southern Telecom (New York)
Updated Jun 25About 14,700 (Southern Telecom … units
The roll-on warmers' power cord can overheat and short circuit, posing a risk of serious injury or death from fire, burn and electrical sho…
Hazard. The roll-on warmers' power cord can overheat and short circuit, posing a risk of serious injury or death from fire, burn and electrical shock hazards.
What to do
Consumers should stop using the recalled waxing kits immediately and contact Southern Telecom for a full refund
Consumers will be asked to destroy the kits by unplugging the warmer's electrical cord, cutting it in half, and upload a photo of the destroyed product, showing the cut electrical cord, …
Yamaha Recalls Model Year 2021-2022 Fleet Golf Cars Due to Risk of Serious Injury or…
Yamaha Golf-Car, of Kennesaw, GA
Updated Jun 11About 8,650 (In addition, about… units
The recalled golf cars' passenger-side brake cable could have been misrouted during assembly. If the cable was misrouted, abnormal wear can…
Hazard. The recalled golf cars' passenger-side brake cable could have been misrouted during assembly. If the cable was misrouted, abnormal wear can occur which can cause the passenger-side cable to break during use, posing a risk of serious injury or death from a crash hazard.
What to do
Consumers should stop using the recalled fleet golf cars immediately and contact an authorized Yamaha Golf Car dealer to schedule a free inspection of the passenger-side brake cable routing
If the cable was misrouted, the dealer will replace the cable with a new, properly routed cable
Conair Expands Recall of Cuisinart Grill Brushes Due to Ingestion Hazard; Over 3.6…
Conair of Stamford, Connecticut
Updated Aug 27About 1,905,805 additional brus… units
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious intern…
Hazard. Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
What to do
Consumers should stop using the recalled grill brushes immediately and contact Conair for a full refund or a credit for use at Cuisinart.com for a full refund plus 20% of the cash refund amount
Consumers will be asked to discard the recalled grill brushes
Modine Manufacturing Company Recalls Airedale Heating and Cooling Ventilation Fans Due to…
Modine Manufacturing, of Racine, Wisconsin
Updated Aug 20About 6,061 (In addition, about… units
The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing …
Hazard. The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing a fire hazard.
What to do
Consumers should stop using the recalled heat pumps immediately and contact Modine Manufacturing Company for written instructions to unplug the recalled ventilation fan or to switch the internal disconnect in the fan to the "off" position
Consumers should contact their Modine distributor to arrang…
Walmart Recalls Mainstays 9-Drawer Fabric Dressers Due to Risk of Serious Injury or Death…
Hop Thang Interior Wood (Vietnam)
Updated May 28About 165,000 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of …
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers if they are not anchored to the wall immediately, place them in an area that children cannot access and contact Walmart for a full refund
Consumers will be asked to return the dressers' drawers to any Walmart store and dispose of the dressers' fram…
Orb Funkee Squeeze Toys Recalled Due to Risk of Serious Injury or Death from Asbestos…
ORB Toys (Canada)
Updated May 21About 121,340 units
The recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse health issues if inhaled.
Hazard. The recalled Orb Funkee squeeze toys may contain fibrous tremolite (asbestos) in the sand, which can cause adverse health issues if inhaled.
What to do
Consumers should take the recalled toys away from children, stop using them immediately and contact The Orb Factory for a refund
Consumers will be asked to verify the code and lot number of the toy, place the toy in a heavy-duty plastic bag, seal the bag securely with tape, and submit a photo of t…
Tiyol Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from…
ZW Creations (China)
Updated May 14About 102,430 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can reach the back of the throat and become lodged, posing a risk of respiratory distress and becoming a deadly choking hazard.
What to do
Consumers should stop using the toy immediately, take it away from children and contact ZW Creations for a free replacement
Consumers will be asked to cut and discard all silicone string tentacles, write "RECALLED" on the main body of the toy using a permanent marker, and submit a photograph of th…
Petzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or…
Petzl America, Salt Lake City, Utah
Updated May 14About 1,270 (In addition, about… units
The recalled harnesses are missing rivets in the FAST LT PIN-LOCK buckles, causing the buckles to open, posing a risk of serious injury or …
Hazard. The recalled harnesses are missing rivets in the FAST LT PIN-LOCK buckles, causing the buckles to open, posing a risk of serious injury or death from a fall hazard.
What to do. Consumers and operators should stop using and selling the recalled harnesses immediately and contact Petzl America at [email protected] for a free replacement harness.
Petzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to…
Petzl America, Salt Lake City, Utah
Updated May 14About 29,300 (In addition, abou… units
The recalled harness' D-ring can release, allowing the attachment point to open, posing a risk of serious injury or death from a fall hazar…
Hazard. The recalled harness' D-ring can release, allowing the attachment point to open, posing a risk of serious injury or death from a fall hazard.
What to do. Consumers, operators and work-at-height professionals should stop using the recalled harnesses immediately and contact Petzl America at [email protected] for a free replacement D ring kit.
Generac Power Systems Expands Recall of Generac and DR Power Electric Start Pressure…
Generac Power Systems, of Waukesha, Wisconsin
Updated May 14About 16,260 (Generac Power Sys… units
The electronic start/stop button on the pressure washer can malfunction and self-start, posing a risk of serious injury or death due to car…
Hazard. The electronic start/stop button on the pressure washer can malfunction and self-start, posing a risk of serious injury or death due to carbon monoxide poisoning, if the unit is in a confined space.
What to do
Consumers should immediately stop using the recalled pressure washer and contact Generac to arrange for a free repair at your dealer's location
The pressure washer can still be used with the battery removed by using the pull-start option to start the unit
Cosyland Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from…
Cosyland Official (China)
Updated May 14125200 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled tower stools immediately and store them away from children until repaired
Contact Cosyland Official for repair parts, which include protective nets, stabilizing feet, and installation instructions
The firm will mail the repair parts directly to consumers f…
ZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from…
ZMC Group, of Los Angeles, California
Updated May 7About 124,560 units
The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easi…
Hazard. The recalled toys violate the mandatory safety standard for children's toys because the toy contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the toys immediately, take them away from children and contact ZMC Group for a full refund
Consumers will be asked to remove the batteries, break each component in half or write "RECALLED" or a large "X" on the product with a permanent marker, and submit a photo of the …
EEMB USA Recalls Battery Pouches Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from August 2023 through April 2026 for between $3 and $9.
Updated May 7About 312,100 units
The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or co…
Hazard. The lithium coin batteries are in pouches that are not child-resistant as required under Reese's Law. If a child swallows button cell or coin batteries, the ingested batteries can cause serious injuries, including internal chemical burns and death.
What to do
Consumers should stop using the lithium batteries immediately, place them in an area that children cannot access and contact EEMB USA to receive a full refund
Note: Button cell and coin batteries are hazardous
Batteries should be disposed of or recycled by following local hazardous waste procedur…
Goal Zero Recalls YETI 3000X Power Stations Due to Serious Risk of Injury from Fire and…
Goal Zero, of Draper, Utah
Updated Aug 20About 46,200 units
The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
Hazard. The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
What to do. Consumers should stop using the power stations immediately and install the free repair in the form of a firmware update available through the Goal Zero application or contact Goal Zero for firmware installation at no cost.
Trsmima Zipline Kits and Zipline Spring Brakes Recalled Due to Fall and Collision…
HuNanBoLuoDianZiShangWuYouXianGongSi D/B/A Trsmima or Hunan Pineapple Electronic Commerce (China)
Updated Jul 30About 60,720 zipline kits and a… units
The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not …
Hazard. The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not stiff enough to safely slow a rider down and the kit design does not include an emergency brake, posing collision and fall hazards.
What to do
Consumers should stop using the TT Trsmima zipline kits and zipline spring brakes immediately and contact Trsmima for a full refund
Consumers will be asked to uninstall the zipline kits and destroy them by cutting the safety belt, seat rope and if included in their model, rachet strap, in half and…
Joyin Expands Recall of Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement…
Joyin US, of Chandler, Arizona
Updated Jul 30About 404,000 (Joyin previously… units
The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shal…
Hazard. The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children may fall or land on a dive stick, resulting in serious piercing injuries. Facial and eye injuries are also possible when children attempt to retrieve the sticks underwater.
What to do
Consumers should stop using the recalled dive sticks immediately, take them away from children and dispose of them
Consumers will be asked to take a photo of the disposed dive sticks in the trash and email it to Joyin at [email protected]
Once received, Joyin will send the consumer redesigned div…
Jake's Fireworks Recalls World Class Fireworks "Skull Strobe" Rockets Due to Risk of…
Jake's Fireworks, of Pittsburg, Kansas
Updated Jul 30About 132,440 units
The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards.
Hazard. The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards.
What to do
Consumers should stop using the fireworks rockets immediately and contact Jake's Fireworks for a full refund
Consumers will be asked to return the fireworks devices to the retail location where they purchased the product or the nearest Jake's Fireworks retail location
Greenworks Tools Recalls 24V and 48V Kobalt Yard Power Tools with USB-C Batteries Due to…
Greenworks Tools
Updated Jul 9About 554,780 units
Charging the lithium-ion batteries through the USB-C port, while the batteries are inserted in the yard power tools can cause the batteries…
Hazard. Charging the lithium-ion batteries through the USB-C port, while the batteries are inserted in the yard power tools can cause the batteries to short-circuit, posing a risk of serious injury from fire hazard.
What to do
Consumers should stop charging the batteries with the USB-C port while the batteries are inserted in the yard power tools immediately and contact Greenworks Tools to receive a free replacement battery
Consumers will be asked to complete the registration form at https://www.greenworkstools.com/page…
Conair Recalls Cuisinart Propel+ Four Burner 3-In-1 Gas Grills Due to Risk of Serious…
Cuisinart
Updated Jul 9About 12,660 (In addition, abou… units
The tempered glass window in the pizza oven can shatter during use, posing a risk of serious injury from laceration hazard.
Hazard. The tempered glass window in the pizza oven can shatter during use, posing a risk of serious injury from laceration hazard.
What to do
Consumers should stop using the recalled Cuisinart Propel+ Four Burner 3-in-1 Gas Grill immediately and visit Conair's website to check if their grill is included in the recall
If affected, follow the instructions to safely remove the tempered glass window on the pizza oven and upload two photogra…
Best Buy Recalls Insignia® Gas Ranges Due to Risk of Serious Injury from a Fire Hazard
Best Buy Purchasing, of Richfield, Minnesota
Updated Jul 9About 3,820 (in addition, about… units
The recalled ranges' front-mounted knobs can be activated accidentally by humans or pets, posing a risk of serious injury from a fire hazar…
Hazard. The recalled ranges' front-mounted knobs can be activated accidentally by humans or pets, posing a risk of serious injury from a fire hazard.
What to do
Consumers should stop using the recalled oven immediately and visit Best Buy's recall website at https://www.recallrtr.com/range to participate in the recall
The firm is offering all consumers a free set of compatible knob covers with instructions for their gas range
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps…
Daikin Comfort Technologies Manufacturing, of Houston, Texas
Updated Jun 25About 13,514 (In addition, abou… units
The heating element can remain energized during a ground fault, despite being turned off, posing a risk of fire or burn injury to consumers.
Hazard. The heating element can remain energized during a ground fault, despite being turned off, posing a risk of fire or burn injury to consumers.
What to do
Consumers should stop using the recalled products immediately and contact Daikin Comfort Technologies Manufacturing, Inc. (DCT) to submit a request for a full refund
Consumers will be required to provide their contact information, cut the product's cord, and then upload a photo of the product's se…
Joolz Recalls Aer2 Car Seat Adapters for Strollers Due to Risk of Serious Injury from…
Joolz USA, of New York, New York
Updated Jun 18About 3,840 (In addition, about… units
The recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, posing a risk of serious …
Hazard. The recalled car seat adapters can fail to properly attach to the stroller, which may allow the car seat to fall, posing a risk of serious injury from a fall hazard.
What to do
Consumers should stop using the Joolz Aer2 Car Seat Adapters immediately, detach them from the stroller and go to http://joolzcarseatadapter.expertinquiry.com to register for a full refund
The firm will provide a video on how to remove the Joolz Aer2 Car Seat Adapters from the stroller
Joyin Recalls Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement; Violate…
Joyin US, of Chandler, Arizona
Updated Jun 11About 254,000 units
The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shal…
Hazard. The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children may fall or land on a dive stick, resulting in serious piercing injuries. Facial and eye injuries are also possible when children attempt to retrieve the sticks underwater.
What to do
Consumers should stop using the recalled dive sticks immediately, take them away from children and dispose of them
Consumers will be asked to take a photo of the disposed dive sticks in the trash and email it to Joyin at [email protected]
Once received, Joyin will send the consumer redesigned div…
HABA USA Recalls Rainbow Rattle Grasping and Teething Toys Due to Risk of Serious Injury…
HABA USA
Updated Aug 27About 2,000 units
The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plasti…
Hazard. The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plastic pieces, posing a risk of serious injury or death from choking and ingestion hazards.
What to do
Consumers should stop using the rattle grasping and teething toy immediately, take it away from children and contact HABA USA to receive a full refund
Consumers will be asked to destroy the toy by cutting the elastic cord, taking a photo of it and uploading a photo of the destroyed toy with their …
JINHEZO Mini Waterproof LED Tea Lights Recalled Due to Risk of Serious Injury or Death…
Mystic ZO (China)
Updated Aug 20About 2,798 units
The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batte…
Hazard. The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injurie…
What to do
Consumers should stop using the recalled LED Tea Lights immediately and contact Mystic Zo for a full refund
To receive a refund, consumers will be asked to email their order number or bar code number, if available, along with a photo of the tea lights disposed of in the trash to jinhemaoyi2016@sin…
GigaCloud Technology USA Recalls Merax Murphy Beds Due to Risk of Serious Injury or Death…
GigaCloud Technology (USA), of El Monte, California
Updated Aug 13About 1,250 units
During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.
Hazard. During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.
What to do
Consumers should stop using the recalled Murphy beds immediately and contact GigaCloud Technology for a free repair kit
Consumers that have not assembled the Murphy bed will receive a repair kit consisting of unloaded piston springs, updated assembly instructions and inspection instructions
DUMOS Nine-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over…
Jiangsu Jiayubo Furniture (China)
Updated Aug 13About 8,981 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access
Consumers should contact DUMOS for a full refund
Consumers will be asked to destroy the dressers by cutting the drawers in half and writing in p…
Deli Jerry Fuel Containers Recalled Due to Risk of Serious Injury or Death from Burn…
Online at Walmart.com from April 2025 through June 2026 for about $36.
Updated Aug 13About 1,750 units
The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not chi…
Hazard. The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not child-resistant, posing a risk of burns and poisoning to children.
What to do
Consumers should stop using the recalled fuel containers immediately and contact Deli OfficeSupplies for a full refund
Consumers will be asked to destroy the fuel container by writing in permanent maker "RECALLED" on the product and to send a photo of the destroyed fuel container to service@steeli…
COMMOWNER Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
AZ Home Concept (China)
Updated Aug 131,694 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encoura…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact AZ Home Concept for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed power washer to [email protected].…
OKK Trading Recalls Easter LED Headbands Due to Risk of Serious Injury or Death from…
OKK Trading, of Vernon, California
Updated Aug 6About 25,200 units
The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batterie…
Hazard. The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
What to do
Consumers should stop using the Easter LED Headbands immediately and contact OKK Trading for a refund
Consumers will be asked to email [email protected] a photograph showing the product being properly disposed of in the trash
Liuqibax Adult Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
Luqiba (China)
Updated Aug 6About 12,000 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
What to do
Consumers should stop using the recalled bed rails immediately and contact Luqiba for a full refund
Consumers will be asked to destroy the bed rails by dismantling them, cutting off the safety strap and storage bag and writing in permanent marker "RECALLED" on the upper and lower rails, and email …
Woodure Toddler Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from…
Shenzhen Muqiqu Creative Development (China)
Updated Jul 30About 91,000 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled tower stools immediately and store them away from children
Contact Shenzhen Muqiqu Creative Development for a repair kit, which includes protective nets, stabilizing feet and installation instructions
The firm will mail the free repair kit directly to cons…
HARPPA Recalls Nordi Toddler Tower Stools Due to Risk of Serious Injury and Death from…
HARPPA, of Denver, Colorado
Updated Jul 3047,166 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled stools immediately and store them away from children
Contact HARPPA for a free repair kit, including shipping
The repair kit consists of protective nets, stabilizing feet and installation instructions
Golden Link Recalls Fantastic Four Cups and Captain America Popcorn Helmet Containers…
Golden Link, of Middletown, New York
Updated Jul 30About 55,350 units
The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain butto…
Hazard. The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. In addition, the products do not bear the warning labels required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious inj…
What to do
Consumers should stop using the Fantastic Four Cups and Captain America Popcorn Helmet Containers immediately and contact Golden Link for a refund of the purchase price of the product
Consumers will be asked to dispose of the product and send a photo showing proof of disposal to productrecall@gold…
15-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
Changzhou Jiaxuan Intelligence Furniture (China)
Updated Jul 30About 12,800 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact EnHomee-Direct for instructions on how to identify affected units and dispose of the dressers to receive a full refund
EnHomee 9-Drawer Fabric Dressers Recalled Due to Risk of Serious Injury or Death from…
Xuzhou Mingquanhe Household (China)
Updated Jul 23About 16,809 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of …
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact Raybee-Direct for instructions on how to identify affected units and dispose of the dressers to receive a full refund
12-Drawer Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over…
Xuzhou Mingquanhe Household, of Changzhou Jiaxuan Intelligence Furniture (China)
Updated Jul 23About 10,040 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers if they are not anchored to the wall immediately and place them in an area that children cannot access
Contact Romorgniz for instructions on how to identify affected units and dispose of the dressers to receive a full refund
Jobon Torch Lighters Recalled Due to Risk of Serious Injury or Death from Fire and Burn…
Online at Amazon.com and Alibaba.com from April 2021 through September 2025 for between $5 and $20.
Updated Jul 1613,200 units
The lighters violate the mandatory safety standard for multipurpose lighters because they do not have the required child-resistant mechanis…
Hazard. The lighters violate the mandatory safety standard for multipurpose lighters because they do not have the required child-resistant mechanisms posing a risk of serious injury or death from fire and burn hazards. In addition, the lighters failed to meet the pre-market lighter submission requirement needed to demonstrate that the lighters feature child-resistant mechanisms and ensuring their safety …
What to do
Consumers should stop using the recalled lighters immediately and contact Jobon Official Store for a full refund
Consumers will be asked to write "RECALLED" in permanent marker on the lighter, submerge it in water in a bowl and send a photo of the marked and submerged lighter to [email protected]…
Projecting LED Finger Light Toys Recalled Due to Risk of Serious Injury Death from…
Amazon.com from December 2024 through March 2026 for about $13.
Updated Jul 262490 units
The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily…
Hazard. The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the recalled finger lights immediately, take them away from children and contact POPOOO for a full refund
Consumers will be asked to remove and properly dispose of the finger lights into the trash and send a photo of the disposed product to [email protected]
Junpower CR2032 Lithium Coin Batteries Recalled Due to Risk of Serious Injury or Death…
JSNJ_Tech (China)
Updated Jul 2About 67,000 units
The lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required under Reese's Law. When…
Hazard. The lithium coin batteries are not sold in child-resistant packaging and do not bear the warning labels as required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns and death.
What to do
Consumers should stop using the recalled coin batteries immediately, place them in an area that children cannot access and contact Junpower for a free replacement battery
Consumers should visit Junpower's recall page at https://www.cognitoforms.com/Junpower2032/recall and follow instructions to re…
Diamond Wipes International Recalls CVS Health Medicated Hemorrhoidal Wipes Due to Risk…
Diamond Wipes International of Chino, California
Updated Jul 2About 75,315 units
The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging …
Hazard. The recalled medicated wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.
What to do
Consumers should secure the wipes out of sight and reach of children immediately and contact CVS for a full refund
Consumers will be asked to return unopened packets of wipes with the retail box packaging to any CVS store
Honlyne LED Party Favors Recalled Due to Risk of Serious Injury Death from Battery…
ABGA Advanced Trading, of Walnut, California
Updated Jun 25About 13,400 units
The LED party favors violate the mandatory safety standard for consumer products because the battery compartment within the light-up produc…
Hazard. The LED party favors violate the mandatory safety standard for consumer products because the battery compartment within the light-up products contains button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
What to do
Consumers should stop using the recalled party favors immediately and contact Huizhou Rongheng Network Technology for a full refund
Consumers will be asked to take a clear photo of the recalled products in the trash and email the photo to [email protected] to receive a refund
GOPO Toys Recalls Pull String Teething Toys Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2023 through March 2026 for between $11 to $15.
Updated Jun 18About 70,410 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
What to do
Consumers should stop using the teething toy immediately, take it away from children and contact GOPO Toys to receive a full refund
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker "DESTROYED" on the main body of the toy and send a photo of…
Timechee Changing Table Dressers Recalled Due to Risk of Serious Injury or Death from…
Fujian Xiniuniu Home Furnishing (China)
Updated Jun 11About 10,354 units
The recalled dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that can result in a risk of serious…
Hazard. The recalled dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that can result in a risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact Timechee for instructions on how to identify affected units and dispose of the dressers to receive a full refund
School Specialty Recalls Tip Restraint Kits Included in Childcraft Furniture Due to Risk…
Childcraft furniture (which included the recalled tip restraint kits) sold through School Specialty stores nationwide a…
Updated Jun 11About 15,616 units
The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards…
Hazard. The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards. Should the defective plastic tip restraints break, consumers could be at risk of serious injuries or death. This is a hidden defect because consumers who purchase and install this product may be under a false sense of security that their furniture is safe fr…
What to do
Consumers should stop using the recalled plastic tip restraints immediately and contact School Specialty for a free replacement tip restraint kit made of stainless steel
Consumers should keep children away from any furniture secured using the recalled plastic tip restraints while waiting for a rep…
LiKee Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death from…
Guangzhou Huanmao Business Service (China)
Updated Jun 11About 24,400 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
What to do
Consumers should stop using the toy immediately, take it away from children and contact ChilanTech for free replacement toy of at least equal value, including shipping
Consumers will be asked to destroy the toys by cutting the silicone tentacles and writing in permanent marker "Recalled" on the to…
Wyze Labs Recalls Solar Cam Pan Security Cameras Due to Risk of Serious Injury from Fire…
Wyze Labs, of Kirkland, Washington
Updated Jun 4About 321,360 (In addition, abo… units
The recalled Wyze Solar Cam Pan security cameras' incorrect assembly instructions can lead consumers to accidentally puncture the lithium i…
Hazard. The recalled Wyze Solar Cam Pan security cameras' incorrect assembly instructions can lead consumers to accidentally puncture the lithium ion battery's metal casing, causing the battery to rapidly overheat, posing a risk of serious injury or property damage from fire and burn hazards.
What to do
Consumers should stop using the recalled Wyze Solar Cam Pan security camera immediately and visit http://www.wyze.com/SCPrecall to determine whether your device is affected by the recall
All consumers who used the long, flat-head screw to install the solar panel on top of the camera should partici…
ZWILLING J. A. Henckels Aktiengesellschaft Recalls Electric Water Kettles Due to Risk of…
ZWILLING J.A. Henckels Aktiengesellschaft, Solingen, Germany
Updated May 14About 113,440 (In addition, abo… units
The kettle's handle can loosen and separate from the kettle, causing hot contents to spill, posing a risk of serious injury due to a burn h…
Hazard. The kettle's handle can loosen and separate from the kettle, causing hot contents to spill, posing a risk of serious injury due to a burn hazard.
What to do
Consumers should stop using the recalled kettles immediately and contact ZWILLING J
Henckels Aktiengesellschaft for a full refund
Consumers in the U.S. should visit www.zwilling.com/kettle-recall for instructions on how to make the kettle unusable, which includes unplugging the kettle, cutting…
Clorox Puerto Rico Recalls 6 Million Scented Mistolin and Lestoil Multi-Purpose Cleaners…
Clorox Manufacturing of Puerto Ri, Puerto Ri
Updated 2 days agoAbout 6.3 million units
The recalled products may contain bacteria, including Pseudomonas aeruginosa, which is an environmental organism found widely in soil and w…
Hazard. The recalled products may contain bacteria, including Pseudomonas aeruginosa, which is an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a brea…
What to do
Consumers should stop using the recalled cleaners immediately
Consumers will be asked to register at https://mistolinrecall.expertinquiry.com/ and submit a picture of the 12-digit UPC code printed on the label and a picture of the date code printed on the side of the bottle and dispose of the prod…
Audio Partnership Recalls Cambridge Audio Yoyo (M) Portable Bluetooth Speakers Due to…
Audio Partnership (England)
Updated 2 days agoAbout 714 units
The lithium-ion batteries in the Cambridge Audio Yoyo (M) Portable Bluetooth Speaker can overheat, posing a fire hazard.
Hazard. The lithium-ion batteries in the Cambridge Audio Yoyo (M) Portable Bluetooth Speaker can overheat, posing a fire hazard.
What to do
Consumers should stop using the recalled speakers immediately, disconnect them from the power supply, stop charging them, store them away from combustible materials and contact Audio Partnership for a full cash refund of $218 or Cambridge Audio online store voucher of $350
Steelite Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and…
Longer 3D (China)
Updated Aug 27About 128 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of …
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of serious injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Longer 3D for a full refund
Consumers will be asked to destroy the power washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to [email protected]
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
YERYORK (China)
Updated Aug 27300 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious ri…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact YERYORK for a full refund
Consumers will be asked to unplug the pressure washer, destroy it by cutting the power cord in half, and send a photo of the destroyed power washer, showing the model number, to yeryorkrecal…
Little Loves & Co. Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury…
Little Loves &, of Olympia, Washington
Updated Aug 27About 590 units
The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazar…
Hazard. The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazard.
What to do
Consumers should take the recalled clothing away from children immediately and contact Little Loves & Co. for a full refund after return of the product
Consumers should contact Little Loves & Co. to receive a pre-paid shipping label to return the garment
Kmaier Recalls Infant Walkers Due to Risk of Serious Injury or Death from Fall Hazard…
Kmaier
Updated Aug 27About 243 units
The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at …
Hazard. The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard.
What to do
Consumers should stop using the recalled walkers immediately and contact Kmaier for a full refund
Consumers will be asked to disassemble the walker; destroy it by cutting the walker’s fabric seat and writing in permanent marker “Recalled” on the top of the tray; and send a photo of the destr…
Excel Industries Recalls Accessory LED Light Kits Due to Risk of Serious Injury from Fire…
Excel Industries, of Hesston, Kansas
Updated Aug 27About 1,800 units
The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard.
Hazard. The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard.
What to do
Consumers should stop using the accessory LED Light Kits immediately and contact their point-of-sale dealers to receive a refund upon return of the light kit
Light kits installed on mowers can be removed either at the local dealer or at the consumer’s residence
AudioLineOut Recalls Studio Six Headphone Amplifiers Due to Risk of Serious Injury or…
Updated Aug 27About 90 units
When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or d…
Hazard. When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or death from electrocution.
What to do
Consumers should stop using the recalled amplifiers immediately and contact AudioLineOut for a free repair
Consumers should contact AudioLineOut at [email protected] for a prepaid shipping label to ship back the product for repair
Alternatively, consumers can utilize the originally supplied va…
Koorlian Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard…
Dreams Bedding Technology PTE. (Singapore)
Updated Aug 20About 251 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do. Consumers should stop using the recalled mattress immediately and contact Dreams Bedding Technology to receive a free cover to put over their mattress to bring it into compliance with the mandatory flammability standards.
CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories Due…
CCM Hockey U.S., of Maple Grove, Illinois
Updated Aug 20About 12,957 units
The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact haz…
Hazard. The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards.
What to do
Consumers should stop using the recalled visors and visor accessories immediately and return the products to the nearest participating retailer for a free replacement
Consumers can choose from the FV1 full visor, FM780 combo cage, or FM580 combo cage
Sunnyside Corporation Recalls 1-K Kerosene Heater and Appliance Fuel Containers Due to…
Amazon.com online and Do-It Best Hardware Stores from May 2026 through July 2026 for about $13.
Updated Aug 13About 960 units
The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mit…
Hazard. The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mitigation devices, posing a deadly risk of flash fire and burn hazard.
What to do
Consumers should stop using the recalled fuel bottles immediately, place them out of reach of children, and contact Sunnyside for a full refund
Consumers will be asked to write "RECALLED" with permanent marker on the bottle; and submit a photo of it to [email protected]
SUGIFT Recalls SUGIFT Pressure Washers Due to Serious Risk of Injury or Death from Shock…
SUGIFT, of Albany, NY
Updated Aug 1313 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encoura…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact SUGIFT for a full refund
Consumers will be asked to destroy the pressure washer by cutting the power cord in half (the product should be completely turned off and unplugged from power outlet) and send a photo of the …
Shengsen Prank Sound Makers Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from April 2024 through April 2026 for about $8.
Updated Aug 13About 667 units
The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithi…
Hazard. The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause se…
What to do
Consumers should stop using the sound maker immediately and contact Shengsen Toys for a full refund
Consumers will be asked to properly dispose of the sound maker into the trash and send a photo of the disposed product to [email protected]
Note: Button cell and coin batteries are hazardous
Ritchey Design Recalls Carbon Bicycle Forks Due to Risk of Serious Injury or Death from…
Ritchey Design, of Reno, Nevada
Updated Aug 13About 775 units
The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's…
Hazard. The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's front wheel, posing a risk of serious injury or death from a fall and crash hazard.
What to do
Consumers are asked to stop using the bicycles equipped with the recalled fork immediately
Please inspect the front crown hole for any attached racks or accessories
The threaded hole located above the front wheel should be closed immediately
Consumers should register at https://ritcheylogic.com/…
Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate…
Online at Amazon.com from November 2025 through March 2026 for between $120 and $140.
Updated Aug 13About 774 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattresses immediately and contact Qabefy for a full refund
Consumers will be asked to destroy the mattress, by writing in permanent marker "Recalled," their name and the current date on the mattress's top surface, and to email a photo of the destroyed matt…
Fastbuy Recalls Zimtown Portable Gas and Fuel Cans Due to Risk of Serious Injury or Death…
Online at Walmart.com and Zimtown.com from May 2026 through July 2026 for between $32 and $63.
Updated Aug 13About 200 units
The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child…
Hazard. The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child-resistant, posing a risk of burns and poisoning to children.
What to do
Consumers should stop using the gas and fuel containers immediately and contact Fastbuy for a full refund
Consumers should disassemble the spout, cut it into pieces with scissors and dispose of it separately from the container
Consumers will be asked to write "RECALLED" on the container and submi…
CuberShop Magnetic Speed Cubes Recalled Due to Risk of Serious Injury or Death from…
SKY CUBE HK (China)
Updated Aug 13About 132 units
The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing…
Hazard. The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestin…
What to do
Consumers should take the recalled loose magnets away from children, stop using them immediately, and contact SKY CUBE HK for information on how to receive a $5 refund
Consumers will be asked to throw away the magnets and email a photo of the disposed magnets to [email protected]
Panasonic Recalls Electric Toaster Ovens Due to Shock and Fire Hazards
Panasonic Manufacturing (Xiamen), of Xiamen, Fujian, China
Updated Jul 16About 11,480 (In addition, abou… units
The power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posing a risk of shock and/…
Hazard. The power cord insulation can be insufficient due to a protective fiberglass sleeve not covering it adequately, posing a risk of shock and/or fire hazard.
What to do. Consumers should stop using the recalled Electric Toaster Oven immediately and contact Panasonic for a full refund.
Conair Recalls Over One Million Cuisinart Grill Brushes Due to Ingestion Hazard
Conair, of Stamford, Connecticut
Updated Jul 2About 1,719,995 units
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious intern…
Hazard. Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
What to do
Consumers should stop using the recalled grill brushes immediately and contact Conair for a full refund or a credit for use at Cuisinart.com for a full refund plus 20% of the cash refund amount
Consumers will be asked to discard the recalled grill brushes
Yamaha Recalls UMAX Bistro and Bistro Deluxe Vehicles Due to Injury Hazard
Yamaha Golf-Car, of Kennesaw, Georgia
Updated Jun 11About 1,101 (In addition, about… units
The recalled Bistro and Bistro Deluxe vehicles have an inaccurate weight capacity certification label. This could result in the vehicle bei…
Hazard. The recalled Bistro and Bistro Deluxe vehicles have an inaccurate weight capacity certification label. This could result in the vehicle being overloaded, which poses an injury hazard.
What to do
Consumers should immediately stop using the recalled UMAX Bistro and Bistro Deluxe vehicles and contact an authorized Yamaha Golf Car dealer to schedule a free replacement of the label
A Yamaha dealer will replace the label at the vehicle's location
MiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or…
MiniWarGaming, doing business as MiniWarGaming Forge
Updated May 28About 22,624 units
The magnets violate the mandatory safety standard for magnets because the high-powered magnets fit within CPSC's small parts cylinder and a…
Hazard. The magnets violate the mandatory safety standard for magnets because the high-powered magnets fit within CPSC's small parts cylinder and are stronger than permitted, posing a deadly ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, …
What to do. Consumers should stop using the magnets immediately and contact MiniWarGaming for instructions on how to obtain a prepaid shipping label and return the products for a full refund.
ABC Trading Recalls Children's Toys Due to Risk of Serious Injury or Death from Battery…
ABC Trading, of Vernon, California
Updated May 21About 84,700 units
The recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that h…
Hazard. The recalled children's toys violate the mandatory standard for toys because they contain button cell batteries and the compartments that hold the batteries can be easily accessed by children, posing a deadly ingestion hazard to children. When button cell and coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and death.
What to do
Consumers should stop using the children's toys immediately and contact ABC Trading for a refund
Consumers will be asked to take a photo of the disposed products in the trash and email the photo to [email protected] to receive a full refund of the retail price
World Bright International Limited Recalls Agio Menlo Woven Patio Swings Due to Risk of…
Cost Wholesale, of Issaquah, Washington
Updated May 14About 18,500 units
The swing seat can detach from the frame while in use, posing a risk of serious injury or death from a fall hazard.
Hazard. The swing seat can detach from the frame while in use, posing a risk of serious injury or death from a fall hazard.
What to do. Consumers should immediately stop using the recalled patio swings and contact World Bright International Limited to receive a free repair in the form of replacement hooks and instructions for replacing the hooks.
Missry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury…
Missry Associates, doing business as Mis Enterprises, of Edison, New Jersey
Updated May 14About 15,120 units
The Misco Sports Badminton Toy Sets violate the mandatory safety standard for children's toys because the shuttlecocks contain button cell …
Hazard. The Misco Sports Badminton Toy Sets violate the mandatory safety standard for children's toys because the shuttlecocks contain button cell batteries that can be easily accessed by children. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns and deaths.
What to do
Consumers should stop using the badminton toy set immediately, take the shuttlecock away from children and contact Missry Associates for a full refund
Consumers will be asked to dispose of the badminton toy set with the shuttlecock (number MT2383) in the trash and send the photo to [email protected]. …
Lithium Coin Batteries Recalled Due?to Risk of Serious Injury or Death from Battery…
LiCB (China)
Updated May 14About 94,000 units
The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button…
Hazard. The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
What to do
Consumers should stop using the coin batteries immediately, place them in an area that children cannot access, and contact LiCB for a full refund
Consumers will be asked to dispose of the batteries according to local hazardous waste guidelines
Note: Button cell and coin batteries are hazardous
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of…
Win Fireworks International, of Grandview, Missouri
Updated Jul 2About 13,500 units
The recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury from explosion and bur…
Hazard. The recalled fireworks can malfunction, and shots can blow out the side of the tube, posing a risk of serious injury from explosion and burn hazards.
What to do
Consumers should stop using the recalled fireworks immediately and return the fireworks to the store where they were purchased for a full refund
Consumers will receive the refund in the form of cash or a refund to their original form of payment
Target Recalls Gigglescape™ Under the Sea Popping Toy Due to Choking Hazard
Target, of Minneapolis, Minnesota
Updated Jul 2About 49,000 units
The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing …
Hazard. The clear plastic dome can detach from the blue plastic base, making the small plastic balls inside the toy accessible to children, posing a choking hazard.
What to do. Consumers should stop using the recalled toy immediately and return it to any Target store for a full refund or contact Target to receive a prepaid return label to return the Gigglescape Under The Sea Popping Toy by mail.
The recalled coffeemakers can become clogged, causing hot liquid or steam to build up and be released unexpectedly during use, posing a ris…
Hazard. The recalled coffeemakers can become clogged, causing hot liquid or steam to build up and be released unexpectedly during use, posing a risk of serious injury from burn hazard.
What to do
Consumers should stop using the coffeemakers immediately and contact Kidisle for a full refund
Consumers will be asked to destroy the coffeemaker by unplugging and cutting the power cord, write "Recalled" in permanent marker on it, and send a photo of the destroyed product with a visible model num…
Wnttmt Baby Walkers Recalled Due to Risk of Serious Injury or Death from Fall and…
Online at Amazon.com from February 2026 through March 2026 for between $65 and $75.
Updated Aug 6About 1,310 units
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to s…
Hazard. The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant walkers have leg openings that allow the child to slip down until the child's head can become entrapped, posing a risk of serious injury or death.
What to do
Consumers should stop using the recalled infant walkers immediately and contact WURUI.BABY for a full refund
Consumers will be asked to disassemble the walker, cut the fabric seat, write "Recalled" on the top of the tray in permanent marker and send a photo of the recalled infant walker to wbabywa…
Wichard Groupe North America Recalls Courant Spliced Kalimba Climbing Ropes Due to Risk…
Courant, of Angers, France
Updated Aug 6About 1,050 units
The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard.
Hazard. The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using the recalled ropes immediately and contact Wichard Groupe North America for a free replacement rope, including shipping
Consumers will be asked to complete the registration form at https://www.wichardgroupe.us/news/post/recall-spliced-kalimba to receive a pre-paid shipp…
Play Yard and Crib Mattresses Recalled Due to Risk of Serious Injury or Death from…
Voomf (China)
Updated Aug 6About 2,401 units
The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain pla…
Hazard. The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain play yards, posing a deadly entrapment hazard. Babies can suffocate in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant f…
What to do
Consumers should stop using the mattresses immediately and contact Voomf for a full refund
Consumers will be asked to destroy the mattresses by writing in permanent marker "Recalled," cutting the play yard mattress in half and cutting the full-sized mattress cover diagonally across the entire matt…
Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet…
Shenzhen Yuejia Mei Maoyi Youxian Gongsi (Shenzhen Yuejia Mei Trading), doing business as BUSOHA (China)
Updated Aug 6About 2,186 units
The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to c…
Hazard. The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and de…
What to do
Consumers should take the fidget sliders away from children, stop using them immediately and contact BUSOHA for a full refund
Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to [email protected] to receive a refund
Little Rawr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death…
Online at Amazon.com from September 2025 through April 2026 for between $11 to $15.
Updated Aug 6About 2,180 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and a deadly choking hazard.
What to do
Consumers should stop using the teething toy immediately, take it away from children and contact Okabesini-us to receive a full refund
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker "RECALLED" on the main body of the toy and send a photo …
KC Imports and Exports Recalls Mini Laser Pointer Keychains Due to Risk of Serious Injury…
KC IMPORTS AND EXPORTS, of Vernon, California
Updated Aug 69,600 units
The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because th…
Hazard. The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause s…
What to do
Consumers should stop using the recalled laser keychains immediately and contact KC Import and Export for refund
To receive a refund, email a photo of the products disposed of in the trash to [email protected]
Head Watersports Recalls Apeks Second Stage Scuba Regulators Recalled Due to Risk of…
Head Watersports of Delray Beach
Updated Aug 6About 1,105 units
The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk …
Hazard. The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk of serious injury or death from a drowning hazard.
What to do. Consumers should stop using the recalled second stage scuba regulators immediately and bring the product to any HEAD Watersports Authorized Retailer who will replace the valve spindle assembly at no cost to the consumer.
DR Power Equipment Recalls Lawn Mowers Due to Risk of Serious Injury or Death from…
Generac Power Systems, of Waukesha, Wisconsin
Updated Aug 6About 320 (In addition, 9 were … units
The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blad…
Hazard. The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blade control system engaged or continue to operate even after the release of the control, posing a serious laceration hazard.
What to do
Consumers should stop using the recalled mowers immediately unless they have already received a free repair kit in the mail from DR Power and it has been installed
If the repair kit has not been installed, contact DR Power to receive updated repair instructions or schedule a free repair from an au…
A2batt Recalls EEMB Lithium Coin Battery Chargers Due to Risk of Serious Injury or Death…
Online at Amazon.com from August 2024 through March 2026 for about $14.
Updated Aug 6About 4,930 units
The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the ch…
Hazard. The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings, as required by Reese's Law. When but…
What to do
Consumers should stop using the charger immediately, remove the batteries and place them in an area that children cannot access
Contact A2batt to receive a full refund
Consumers will be asked to write "RECALL" on the charger
If batteries remain in packaging, dispose of the batteries according to…
Mommy's Baby Lovely Deluxe Baby Doll Playsets Recalled Due to Risk of Serious Injury or…
Online at Temu.com from August 2024 through November 2025 for about $31.
Updated Jul 30About 1,034 units
The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories …
Hazard. The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts, posing a deadly choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children, and contact TOYHW for a full refund
Consumers will be asked to throw away the baby doll playset and email a photo of the disposed product to [email protected] to receive a full refund
5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
Online at Amazon.com from September 2023 through June 2026 for about $180.
Updated Jul 30About 1,980 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact KAIFAM for instructions on how to identify affected units and receive a full refund
Consumers will be asked to write "RECALLED" on the t…
Aojieni Silicone Recalls Sili Factory Pull String Teething Toys Due to Risk of Serious…
Shenzhen Aojieni Silicone Technology (China)
Updated Jul 23About 5,918 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and deadly choking hazard.
What to do
Consumers should stop using the teething toy immediately, take it away from children and contact Aojieni Silicone to receive a full refund
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker "RECALLED" on the main body of the toy and send a ph…
Warren James Recalls the Copper Cup Found in Flashgitz Relic Lunch Boxes Due to Risk of…
Flashgitz shop from September 2025 through October 2025 for about $25.
Updated Jul 16About 7,000 units
The cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning hazard. Lead is toxic if i…
Hazard. The cup in the lunch boxes contains high lead concentration levels for drinking vessels, posing a lead poisoning hazard. Lead is toxic if ingested by adults or children and can cause adverse health issues.
What to do
Consumers should stop using the recalled cups immediately and contact the firm for instructions on how to receive a replacement cup
Consumers who purchased the lunch boxes directly from Warren James will be sent a free replacement cup to the address previously provided in the original purchase ord…
SDADI Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from…
Yiwushi Bihe Trading (China)
Updated Jul 165,952 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do. Consumers should stop using the recalled tower stools immediately, store them away from children and contact Yiwushi Bihe Trading for a full refund.
Oitnlaughter Projecting Finger Light Toys Recalled Due to Risk of Serious Injury or Death…
Online at Amazon.com from July 2025 through April 2026 for about $14.
Updated Jul 16About 1,012 units
The recalled finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily acc…
Hazard. The recalled finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact Delightmi for a full refund
Consumers will be asked to properly dispose of the finger lights into the trash and send a photo of the disposed product to [email protected] Note: Button cell batter…
Liizousuda Paint Thinner Bottles Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from March 2025 through February 2026 for about $10.
Updated Jul 16About 4,200 units
The paint thinner contains low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the Poison Preve…
Hazard. The paint thinner contains low-viscosity petroleum distillates, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children. Additionally, petroleum distillates can get into the lungs, causing chemical pneumonia and/or pul…
What to do. Consumers should secure the recalled paint thinner out of the sight and reach of children immediately and contact Shenzhen Gudebo Technology for information on how to obtain a replacement bottle with a child-resistant closure, into which consumers should transfer the recalled bottle's contents.
Flaunt Recalls Magsafe Battery Chargers Due to Risk of Serious Injury or Death from Fire…
Flaunt
Updated Jul 9About 1,400 units
The lithium-ion battery in the recalled power banks (chargers) can overheat and ignite, posing a risk of serious injury or death from fire …
Hazard. The lithium-ion battery in the recalled power banks (chargers) can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled power banks immediately and contact Flaunt for a full refund of the $65 purchase price in the form of a check or as an $80 store credit at flauntcases.com
Consumers will be asked to register at www.flauntcases.com/pages/recall and submit two photographs
Biometric Gun Safes Recalled Due to Serious Injury Hazard and Risk of Death; Sold…
Jomani International, of Monterey Park, California
Updated Jul 99,100 units
The biometric lock on the gun safes can be opened by unauthorized users, posing a serious injury hazard and risk of death.
Hazard. The biometric lock on the gun safes can be opened by unauthorized users, posing a serious injury hazard and risk of death.
What to do
Consumers should immediately stop using the biometric feature of the recalled safe, remove the batteries from the safe, and only use the key when storing firearms
AMASKY Nursing Pillows Recalled Due to Risk of Serious Injury or Death from Suffocation…
Amazon.com from January 2026 through March 2026 for between $24 and $30.
Updated Jul 24008 units
The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows and in…
Hazard. The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows and infant support cushions because they can obstruct an infant's breathing, posing a serious risk of injury or death from suffocation.
What to do
Consumers should stop using the recalled nursing pillows immediately and contact Pretty-Life for a full refund
Consumers will be asked to cut the pillow in half and send a photo of the destroyed pillow to [email protected]
Shield Line Recalls MedPride Baby Oil Bottles Due to Risk of Serious Injury or Death from…
Various discount and medical supply stores primarily in the New York tri-state area, such as 1$ Zone and Yong Tai Dis…
Updated Jun 25About 8,420 units
The baby oil contains low-viscosity hydrocarbons, which must be in child-resistant packaging, as required by the Poison Prevention Packagin…
Hazard. The baby oil contains low-viscosity hydrocarbons, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The baby oil's packaging is not child-resistant, posing a risk of serious injury or illness from poisoning if the contents are swallowed by young children. Additionally, petroleum distillates can get into the lungs, causing chemical pneumonia and/or pul…
What to do
Consumers should secure the baby oil out of sight and reach of children immediately and contact Shield Line for a refund
Consumers will be asked to submit a photo of the recalled product in the trash to receive a full refund
Montessori Busy Board Toys Recalled Due to Risk of Serious Injury or Death from Magnet…
Online at Amazon.com from March 2026 through May 2026 for about $16.
Updated Jun 25About 1,013 units
The busy boards violate the mandatory safety standard for toys because magnets can detach, posing a deadly ingestion hazard. When high-powe…
Hazard. The busy boards violate the mandatory safety standard for toys because magnets can detach, posing a deadly ingestion hazard. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.
What to do
Consumers should stop using the recalled busy boards and immediately take them away from children
Consumers can contact Small Fish for information on how to receive a full refund
Consumers will be asked to throw away the recalled busy board and email a photo of the disposed product to smallfishre…
Charger for the Therabody Theragun, G4 PRO massage device, and products which include the…
Therabody
Updated Jun 23584224 units
Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Fi…
Hazard. Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the product caught fire and other reports regarding visible smoke, melting, charger burn, burning odor, and overheating.
Veseacky Pajama Sets Recalled Due to Risk of Serious Injury Death from Burn Hazard…
Shenzhen City ShengRu Fu Shi, doing business as Veseacky (China)
Updated Jun 18About 3,700 units units
The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from …
Hazard. The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.
What to do
Consumers should stop using the recalled pajama sets immediately and contact Veseacky for a full refund
Consumers will be asked to destroy the pajamas by cutting them in half and send a photo of the destroyed pajama set to [email protected]
Joolz Recalls Aer2 Car Seat Adapters for Strollers Due to Risk of Serious Injury or Death…
Online at CooCooBabyOfficial.com and Amazon.com from December 2024 through March 2026 for between $35 and $70.
Updated Jun 18About 2,355 units
The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit…
Hazard. The baby loungers violate the mandatory standard for Infant Sleep Products because the sides are shorter than the minimum side height limit to secure the infant; the sleeping pad's thickness exceeds the maximum limit, posing a suffocation hazard; and an infant could fall out of an enclosed opening at the foot of the lounger or become entrapped. The portable loungers do not have a stand, posing a …
What to do
Consumers should stop using the baby loungers immediately and contact CooCooBaby for a full refund
Consumers should remove the sleeping pad, cut up the sides of the baby lounger and the sleeping pad and email a photo of the destroyed lounger to [email protected] to obtain a full refun…
Bada Boom Fireworks Recalls Pyro Diablo "Diablo Rising" Fireworks Due to Risk of Serious…
Bada Boom Fireworks, of Blakeslee, Pennsylvania
Updated Jun 18About 1,060 units
The recalled fireworks violate the ban for aerial fireworks devices intended to produce audible effects because they have a pyrotechnic com…
Hazard. The recalled fireworks violate the ban for aerial fireworks devices intended to produce audible effects because they have a pyrotechnic composition that exceeds the federal limit, posing deadly explosion and burn hazards. Overloaded fireworks can result in a greater than expected explosion.
What to do
Consumers should stop using the recalled fireworks devices immediately and contact Bada Boom Fireworks for a full refund
Consumers will be asked to return the fireworks device to Bada Boom Fireworks retail locations
BABESIDE Doll and Stroller Children's Toys Recalled Due to Risk of Serious Injury or…
Huizhou Huitong Crafts (China)
Updated Jun 18About 2,200 units
The recalled toys violate the small parts ban because they are intended for children under three and the small pacifier poses a deadly chok…
Hazard. The recalled toys violate the small parts ban because they are intended for children under three and the small pacifier poses a deadly choking hazard to young children. In addition, the eyes on the plush bear can detach, also posing a choking hazard.
What to do
Consumers should stop using the recalled toys' plush bear and pacifier immediately, take them away from children and contact HYBDOLLS for free replacement similar toy accessories, including shipping
Consumers will be asked to destroy the toy's plush bear and pacifier by cutting the bear in half an…
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of…
Arizer Tech
Updated Jun 18About 5,000 units
The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from …
Hazard. The pajama sets violate the mandatory safety standards for children's sleepwear, posing a risk of serious injury or death to children from burns.
What to do
Consumers should stop using the Arizer Solo III portable electronic vaporizers immediately and contact 7111495 Canada regarding a replacement Solo III V2 unit
Consumers who register for the recall and have serial numbers confirmed to fall within the affected serial number ranges will receive instr…
Nimood Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com and Nimood.com from November 2024 through January 2026 for between $55 and $80.
Updated Jun 11About 6,187 units
The recalled bed rails violate the mandatory standard for adult portable bed rails, because users can become entrapped within the bed rail …
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails, because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Furthermore, the bed rails' push p…
What to do
Consumers should stop using the recalled bed rails immediately and contact Nimood US for a full refund
Consumers will be asked to destroy the bed rail by cutting the black fabric mesh bag off the rail and the black safety strap in half, write "RECALLED" on a piece of paper, take a photo of this al…
Hopelight Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Amazon.com from August 2023 through May 2026 for between $24 and $28.
Updated Jun 11About 5,770 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact MOCCI SHOP for a full refund
Consumers will be asked to cut the storage bag, cut the handrails' foam, write "RECALLED" on the upper and lower bed rails with a permanent marker, take a photo of the marked bed …
Arctic Zone Titan Pro Coolers Recalled Due to Risk of Serious Injury or Death from Burn…
Theblacksheepfam.com, Maisonette.com, Etsy.com, Instagram.com, and Facebook.com from October 2023 through February 2026…
Updated Jun 11About 2,100 units
The recalled children's pajamas violate the mandatory flammability safety standard for children's sleepwear, posing a risk of serious burn …
Hazard. The recalled children's pajamas violate the mandatory flammability safety standard for children's sleepwear, posing a risk of serious burn injuries or death to children.
What to do
Consumers should stop using the pajamas immediately and contact The Black Sheep Fam for a full refund
Consumers will be asked to cut the products in half and email a photo of the destroyed garment to [email protected], then dispose of the product
7-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
Online at Amazon.com from September 2023 through May 2026 for about $160.
Updated Jun 11About 3,000 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Consumers will be asked to pull out all seven drawers for destruction and write on the cabinet in permanent marker the word "RECALLED," take a ph…
Vornado Air Recalls SRTH Small Room Tower Heaters Due to Fire Hazard
Vornado Air, of Andover, Kansas
Updated Jun 4About 255,000 (In addition, abo… units
The recalled heater's fan blade can detach from the motor shaft, which can cause the fan to slow or stop, leading to overheating and meltin…
Hazard. The recalled heater's fan blade can detach from the motor shaft, which can cause the fan to slow or stop, leading to overheating and melting of the enclosure and internal parts. Melted internal parts can ignite and breach the enclosure if the thermal cut off or fuse does not timely activate, posing a fire hazard.
What to do. Consumers should stop using the recalled heaters immediately and contact Vornado for instructions on how to submit photos of the product and proof of destruction to receive a full refund.
TOMY Recalls Boon NURSH 8 oz Reusable Baby Bottles Due to Choking Hazard; Sold at Walmart
TOMY International, of Oak Brook, Illinois
Updated Jun 4About 40,000 units
The hard plastic outer shell can bubble or partially peel off, resulting in loose pieces of film-like plastic that pose a choking hazard to…
Hazard. The hard plastic outer shell can bubble or partially peel off, resulting in loose pieces of film-like plastic that pose a choking hazard to young children.
What to do. Consumers should stop using the recalled baby bottles immediately and contact TOMY to receive a refund in the form of a $22 booninc.com store credit or a replacement set of three bottles in a different color.
Joy Furniture Recalls Talan and Royce Living Room Furniture Sets Due to Risk of Serious…
Zhejiang Mingrui Furniture aka Joy Furniture
Updated May 28About 10,400 units
The power switch on the sofa, loveseat, or recliner can malfunction and overheat posing a risk of serious injury from a fire hazard.
Hazard. The power switch on the sofa, loveseat, or recliner can malfunction and overheat posing a risk of serious injury from a fire hazard.
What to do
Consumers should stop using the power recliner switch on their furniture set and unplug the power cord immediately then go to http://www.warrantyservice.com/JoyFurnitureRecall to participate in the recall
The firm is offering all consumers a free replacement power recliner switch on the sofa, love…
Guidecraft Children's Standing Towers Recalled Due to Risk of Serious Injury from Fall…
Guidecraft, of Mocksville, North Carolina
Updated May 1425235 units
The platform inside the recalled tower can loosen over time, causing it to become unstable or detach, and ultimately posing a fall hazard t…
Hazard. The platform inside the recalled tower can loosen over time, causing it to become unstable or detach, and ultimately posing a fall hazard to young children.
What to do. Consumers should stop using the recalled towers immediately and contact Guidecraft for free repair parts and installation instructions.
Hampton Bay Halwin 52-Inch Ceiling Fans Recalled Due to Impact and Injury Hazards…
Youngo, of Huizhou, China
Updated Aug 13About 9,460 units
The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.
Hazard. The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.
What to do
Consumers should stop using the recalled ceiling fans immediately and contact Youngo for either a full refund by ACH payment or store credit in the form of a Home Depot gift card
To receive either option, consumers should contact Youngo with proof of purchase or a photograph of the serial number (…
SUNS International Recalls Residential Elevator Interlock Switches Due to Fall and…
SUNS International, of Chelmsford, Massachusetts
Updated Jun 4About 7,000 units
The affected interlock switches can become stuck in a retracted position, allowing the exterior door to remain unlocked, posing a risk of d…
Hazard. The affected interlock switches can become stuck in a retracted position, allowing the exterior door to remain unlocked, posing a risk of death or serious injury if the elevator is called to another floor.
What to do. Consumers should stop using their residential elevator containing the SUNS interlock switch immediately and contact SUNS or their elevator installer listed below for free professional installation of a replacement interlock switch.
Little Grape Land Recalls Nursing Pillows Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2025 through April 2026 for between $28 and $30.
Updated Jun 4About 1,430 units
The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows and in…
Hazard. The recalled nursing pillows advertised for infant feeding and tummy time violate the mandatory safety standards for nursing pillows and infant support cushions because they can obstruct an infant's breathing, posing a serious risk of injury or death from suffocation.
What to do
Consumers should stop using the recalled nursing pillows immediately and contact Little Grape Land for a full refund
Consumers will be asked to cut the pillow in half and send a photo of the destroyed pillow to [email protected]
Missry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury…
Missry Associates, doing business as Mis Enterprises, of Edison, New Jersey
Updated May 28About 2,016 units
The racket sets violate the mandatory standard for toys because the screw on the racket used to secure the battery compartment does not rem…
Hazard. The racket sets violate the mandatory standard for toys because the screw on the racket used to secure the battery compartment does not remain attached when opened, and the button cell batteries in the shuttlecock can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the racket set immediately, take the shuttlecock away from children and contact Missry Associates for a full refund
Consumers will be asked to dispose of the racket set with the shuttlecock in the trash and send a photo of the set in the trash to [email protected]
Lithium Coin Batteries Recalled Due to Battery Ingestion; Violates Federal Statute for…
Proudly American Store (Canada)
Updated May 28About 8,000 units
The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button…
Hazard. The recalled coin batteries are not in child-resistant packaging and do not bear the warning labels required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
What to do
Consumers should stop using the coin batteries immediately, place them in an area that children cannot access and contact Proudly American Store for a full refund
Consumers will be asked to dispose of the batteries according to local hazardous waste guidelines
PandaEar Recalls Portable Hook-On Chairs Due to Risk of Serious Injury or Death from Fall…
Online at Amazon.com from February 2022 through November 2025 for about $25.
Updated May 21About 9,700 units
The recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch restraints can be remove…
Hazard. The recalled portable hook-on chairs violate the mandatory standard for portable hook-on chairs because the crotch restraints can be removed without the use of a tool and infants can fall through an opening, posing a deadly fall hazard.
What to do. Consumers should stop using the recalled portable hook-on chairs immediately and contact PandaEar to receive a full refund.?Consumers will be asked to disassemble the product, cut the restraint straps and fabric seat, and email PandaEar at [email protected] photographs clearly showing the…
ABC Trading Recalls WSDZ Light-up Glasses Due to Risk of Serious Injury or Death from…
ABC Trading, of Vernon, California
Updated May 21About 2,900 units
The recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batte…
Hazard. The recalled glasses violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injurie…
What to do
Consumers should stop using the recalled glasses immediately, place them in an area where children cannot access them and properly dispose of the batteries
Contact ABC Trading for a full refund
Consumers will be asked to dispose of the glass and send a photo of the product in the trash and email …
BRP Recalls Can-Am All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury and Death…
BRP US, of Sturtevant, Wisconsin
Updated May 14About 2,820 units
The ATV's speed limiter control can malfunction, causing unexpected speed and acceleration, posing a serious risk of injury or death from c…
Hazard. The ATV's speed limiter control can malfunction, causing unexpected speed and acceleration, posing a serious risk of injury or death from crash hazard.
What to do
Consumers should stop using the Speed Limiter Mode immediately and contact an authorized Can-Am Off-Road dealer to schedule a free repair at the dealership, involving a software update that will take less than one hour
To find an authorized dealer visit https://can-am.brp.com/off-road/us/en/find-a…
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G…
Fresenius Medical Care Holdings
Updated May 121,756,108 units units
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the pote…
Hazard. Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
Svnntaa Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and…
Online at Amazon.com from August 2023 through January 2026 for about $32.
Updated May 7About 4,200 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Furthermore, the bed rails' push pi…
What to do
Consumers should stop using the recalled bed rails immediately and contact Eokeanon for a full refund
Consumers will be asked to dismantle and destroy the bed rail by cutting the black fabric mesh bag off the rail and the black safety strap in half, write "Recalled" in permanent marker on the main…
Favoto Bicycle Helmets Recalled Due to Risk of Serious Head Injury; Violate Mandatory…
Shenzhen Favoto, doing business as Favoto (China)
Updated May 7About 2,200 units
The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, la…
Hazard. The recalled helmets violate the mandatory safety standard for bicycle helmets because they do not comply with the positional stability, labeling and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
What to do
Consumers should stop using the helmets immediately and contact Favoto for a full refund
Consumers will be asked to destroy the recalled helmet by cutting the straps and write "Recalled" and email a photo of the destroyed helmet to [email protected]
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 163,600 cartons x 6 x 10 (in blis… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Hazard. Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 16936 cartons x 12 x 3 x 10 (in b… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Hazard. Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a…
DABIGATRAN ETEXILATE
Updated Jul 16924 cartons x 12 x 6 x 10 (in b… units
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and To…
Hazard. Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydro…
Hazard. Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Vanderhall North America Recalls Brawley GTS Electric Recreational Off Highway Vehicles…
Vanderhall North America, of Provo, Utah
Updated Aug 6About 210 units
The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of ser…
Hazard. The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of serious injury or death from a crash hazard.
What to do
Consumers should stop using their vehicles immediately and contact Vanderhall North America for instructions on how to update their vehicles to firmware version 7.1.0 through the Vanderhall customer mobile app
The updated software was released on April 15, 2026, and can be identified by Vanderhall…
Syera Projecting Finger Light Toys Recalled Due to Risk of Serious Injury from Battery…
Online at Temu.com from December 2025 through April 2026 for between $8 and $16.
Updated Aug 6About 184 units
The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily…
Hazard. The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact Syera for a full refund
Consumers will be asked to remove and properly dispose of the finger lights into the trash and send a photo of the disposed product to [email protected]
Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet…
Huoshan County Haozhou E-commerce, doing business as PIXLABBY (China)
Updated Aug 6860 units
The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestio…
Hazard. The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poi…
What to do
Consumers should take the fidget sliders away from children, stop using them immediately and contact PIXLABBY for a full refund
Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to [email protected] to receive a refund
Fitueyes Recalls Laziza Dressers Due to Risk of Serious Injury or Death from Tip-Over and…
Fitueyes, of City of Industry, California
Updated Aug 6About 150 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact Fitueyes for a full refund
Consumers will be asked to write the word "recalled" on the top and all sides of the dresser with a permanent…
OCOOPA Direct Recalls 1.5 Million Rechargeable Hand Warmers Due to Risk of Serious Injury…
OCOOPA Direct (China)
Updated Jul 30About 1.5 million units
The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn h…
Hazard. The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled hand warmers immediately and contact OCOOPA Direct for a full refund in the form of an OCOOPA gift card or the original form of payment
Consumers will be asked to write in permanent marker "RECALLED" on the hand warmer and submit a photo showing that markin…
Mangohood Direct Kids Kitchen Standing Towers Recalled Due to Risk of Serious Injury and…
Mangohood Direct (China)
Updated Jul 30105 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled tower stools immediately and store them away from children until repaired
Contact Hangzhou Xinyanchuangxin for repair parts, which include stabilizing feet and installation instructions
The firm will mail the repair parts directly to consumers free of char…
Sviyatp Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment…
Online at Amazon.com from March 2026 through June 2026 for about $18.
Updated Jul 23About 670 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing d…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately and contact Sviyatp for a full refund
To receive a refund, consumers will be asked to remove the drain cover from the pool, write "RECALL" with a marker on the cover, take a photo, the…
Peony Design Recalls Personalized Baby Bibs and Stroller Bags Due to Risk of Serious…
Peony Design, of Howell, MI
Updated Jul 23About 52 units
The snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking hazard to young child…
Hazard. The snap can detach from the recalled bibs and stroller bags, posing a risk of serious injury or death from a choking hazard to young children.
What to do
Consumers should take the recalled baby bibs and stroller bags away from children immediately, stop using them, and contact Peony Design to receive a full refund
Consumers will be asked to discard the recalled baby bibs and stroller bags
OeyUoc Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment…
Online at Amazon.com from April 2026 through June 2026 for about $18.
Updated Jul 23About 404 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing d…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain cover immediately and contact Yuanxinxiang for a full refund
To receive a refund, remove the drain cover from the pool, write "RECALL" with a permanent marker on the cover, take a photo of the marked cov…
CuddleCubs Creations Teething Toy Sets Recalled Due to Risk of Serious Injury or Death…
YouRfocus
Updated Jul 23About 404 units
The recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone string…
Hazard. The recalled teething toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of a child's throat and become lodged, posing a risk of respiratory distress and a deadly choking hazard.
What to do
Consumers should stop using the pull string teething toys immediately, take them away from children and contact YouRfocus for a full refund
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker "DESTROYED" on the main body of the toy and send a …
Wade Logan Annyka 9-Drawer Fabric Dressers Recalled Due to Risk of Serious Injury or…
Wuxi Leclaire Home Products (China)
Updated Jul 16About 180 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers if they are not anchored to the wall immediately and place them in an area that children cannot access
Contact Ningbo Jiangdong Peter International Trading for instructions on how to identify affected units and dispose of the dressers to receive a …
Noerishia Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from March 2026 through April 2026 for about $100.
Updated Jul 16About 504 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact Hurzein for a refund
Consumers will be asked to cut off the gray foam handgrip padding and cut the securing straps in half, to render them unusable, then take a photo of the destroyed bed rail and send it to …
MNIENT Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Zhuzhoushizuisuanshangmaoyouxiangongsi (China)
Updated Jul 16About 330 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails do not meet structural stability or retention strap requirements, posing a fall hazard. Additionally, the bed rails' push p…
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact Zhuzhoushizuisuanshangmaoyouxiangongsi for a full refund
Consumers will be asked to cut the foam padding on the bed rail handle grips, take a photo of the destroyed bed rail and email the photo to mnientrecal…
Currey & Company Recalls Nottaway Chandeliers Due to Risk of Serious Injury or Death from…
Currey &, of Atlanta, Georgia
Updated Jul 16About 447 units
The recalled chandeliers lack proper electrical grounding, posing a risk of serious injury or death from electrocution hazard.
Hazard. The recalled chandeliers lack proper electrical grounding, posing a risk of serious injury or death from electrocution hazard.
What to do
Consumers should stop using the recalled chandeliers immediately and contact Currey & Company for a free replacement chandelier, including shipping and installation at no cost to the consumer
Currey & Company will reimburse consumers for the full cost to remove the recalled chandelier and to insta…
WonderStone Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall…
Online at Walmart.com in April 2026 for about $80.
Updated Jul 9About 70 units
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to s…
Hazard. The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a risk of serious injury or death due to a fall hazard.
What to do
Consumers should stop using the recalled infant walkers immediately and contact Wonder Stone Toys for a full refund
Consumers will be asked to disassemble the walker, remove and cut the fabric seat, write "Recalled" on the top of the tray in permanent marker and send a photo of the disassembled in…
Moodooy Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and…
Online at Amazon.com in February 2026 for about $38.
Updated Jul 9About 228 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact YUEZHANG for a full refund
Consumers will be asked to cut the black safety strap in half, write "RECALLED" on the upper and lower bed rails with a permanent marker, take a photo of the marked bed rail with th…
Vevor Recalls Baby Loungers Due to Risk of Serious Injury or Death from Entrapment and…
VEVOR.com, Amazon.com and Wayfair.com from November 2024 through January 2026 for about $30.
Updated Jul 2About 237 units
The recalled baby loungers violate the mandatory safety standard for infant sleep products. The sides are too low to contain an infant and …
Hazard. The recalled baby loungers violate the mandatory safety standard for infant sleep products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations cr…
What to do
Consumers should stop using the recalled baby loungers immediately and contact Vevor for a full refund
Consumers will be asked to remove the foam and pad from the baby lounger's cover and cut the cover, foam and pad in half
Consumers will email photos of the destroyed pieces [email protected]…
Topyond Pool Drain Ports with Covers Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from May 2024 through May 2026 for about $46.
Updated Jul 2About 304 units
The recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA…
Hazard. The recalled drain ports with covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to consumers.
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain port and cover immediately and contact Topyond for a full refund
To receive a refund, consumers should remove the drain cover from the pool, write "RECALL" with a marker on the cover, take a photo, then …
Cooper Lighting Recalls Metalux Optimized High Bay LED Light Fixtures Due to Fire Hazard
Cooper Lighting, of Peachtree City, Georgia
Updated Jul 2About 42,000 units
The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard.
Hazard. The LED's board can overheat or come into contact with the lens or nearby combustible materials, posing a fire hazard.
What to do
Consumers should stop using the recalled light fixtures immediately and contact Cooper Lighting to schedule a free repair or replacement
Consumers will be asked to complete a form at www.content.cooperlighting.com/ohb-recall to register the light fixtures and schedule a repair or replacement
Yamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death…
Yongkang Ruihe Metal Products (China)
Updated Jun 25About 200 units
The recalled youth ATVs violate the mandatory safety standard for ATVs because they are missing brake lights, reducing visibility of the yo…
Hazard. The recalled youth ATVs violate the mandatory safety standard for ATVs because they are missing brake lights, reducing visibility of the youth ATV to other vehicles, posing a deadly crash hazard.
What to do. Consumers should stop using the recalled youth ATVs immediately and contact Yamazuki for a free repair kit.
Raychy Children's Light Sneakers Recalled Due to Risk of Serious Injury or Death from…
Carina and Rambo (China)
Updated Jun 25About 500 units
The recalled sneakers violate the mandatory standard for consumer products with button cell and coin batteries because the lithium coin bat…
Hazard. The recalled sneakers violate the mandatory standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injur…
What to do
Consumers should stop using the sneakers immediately and contact Carina and Rambo for a refund
Consumers will be asked to cut the shoe tongue, write "RECALLED" on both sides of the sneakers using a permanent marker, and provide a photo of disposal to [email protected] in order to receive th…
Spa Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and…
Online at Amazon.com from September 2025 through March 2026 for about $16.
Updated Jun 18About 340 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing e…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to consumers.
What to do
Spa owners, spa operators and consumers should stop using spa/hot tubs with the recalled pool drain covers immediately
To receive a refund, consumers should remove the drain cover from the spa/hot tub, write "RECALL" with a marker on the cover, take a photo, then dispose it
SHEIN Distribution Corporation Recalls Michley Children's Pajamas Due to Risk of Serious…
SHEIN Distribution, of Los Angeles, California
Updated Jun 18About 160 units
The recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injurie…
Hazard. The recalled children’s pajamas violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn injuries or death.
What to do
Consumers should stop using the recalled pajamas immediately and contact SHEIN for a full refund
Consumers will be asked to destroy the pajamas by cutting them in half and send a photo of the destroyed pajamas to [email protected]
Consumers should then dispose of the destroyed product
Houoto 642-2150V Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from…
Foshan Nanhai District Haichen Tengfei Hardware Factory (China)
Updated Jun 11About 595 units
The drain covers do not bear the required product markings, in violation of the mandatory safety standard under the Virginia Graeme Baker P…
Hazard. The drain covers do not bear the required product markings, in violation of the mandatory safety standard under the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing risk of serious injury or death from entrapment and drowning hazards. The drain covers also fail to meet safety requirements because they are missing statements regarding the service life of the covers and installation and…
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately
To receive a refund, consumers will be asked to remove the drain cover from the pool, destroy or otherwise render the drain cover unusable, write in permanent maker "Recalled" on the r…
Updated May 262,050cs/12/12oz pouches + 55,31… units
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results…
Hazard. Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Updated May 261,363cs/12/12oz pouches + 16,29… units
Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results…
Hazard. Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed…
Hazard. Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF…
OBP Medical
Updated Jul 138,224 boxes (148,032 units) units
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact…
Hazard. There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconne…
Hazard. Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exc…
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay…
Hazard. out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no …
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…
ResMed
Updated Jun 25168,069 devices globally units
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state a…
Hazard. Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Covidien, LP
Updated Jun 24135,875 total units
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…
Covidien, LP
Updated Jun 24135,875 total units
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile suture…
Hazard. Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may resu…
Hazard. Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient anesthesia and may lead to intraoperative awareness.
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11508,151 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11193,000 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufact…
Hazard. Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding whic…
Hazard. Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product…
Fresh & Ready Foods
Updated Jun 25216 units units
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patt…
Hazard. Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.
Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC…
Fresh & Ready Foods
Updated Jun 25377 units units
Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a …
Hazard. Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.
Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment and…
Online at Amazon.com from January 2026 through April 2026 for about $16.
Updated Jun 4About 370 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing d…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to swimmers and bathers.
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately and contact Broqixin for a full refund
Consumers will be asked to remove the drain cover from the pool, write in permanent maker "Recalled" on the removed cover, and send a photo of th…
Crenlux Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment…
Online at Amazon.com from June 2025 through March 2026 for about $20.
Updated Jun 4About 200 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing d…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing deadly entrapment and drowning hazards to swimmers and bathers.
What to do
Pool owners, pool operators and consumers should stop using pools with the recalled pool drain covers immediately and contact Eicong for a full refund
Consumers will be asked to destroy the cover by writing in permanent maker "Recalled" on it and to send a photo of the destroyed cover to Crenlux_r…
Bicycle Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury…
Online at Amazon.com from May 2025 through February 2026 for about $23.
Updated Jun 4About 520 units
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuatio…
Hazard. The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
What to do
Consumers should stop using the helmets immediately and contact Gudook Outdoor Sports for a full refund
Consumers will be asked to destroy the recalled helmet by cutting the straps and email a photo of the destroyed helmet, showing with the helmet's batch number, to [email protected]
The recalled toys violate the mandatory safety standard for toys because the mini flashlight included with the fidget spinner balls contain…
Hazard. The recalled toys violate the mandatory safety standard for toys because the mini flashlight included with the fidget spinner balls contains button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should take the Luminous Fidget Spinner Ball's mini flashlight away from children, stop using them immediately and contact Anzmtosn for a full refund
Consumers will be asked to remove the batteries, properly dispose of them immediately, throw away the mini flashlight and submit a photo o…
Daoen Recalls Zen Magnetic Promotional Ball Sets Due to Risk of Serious Injury or Death…
Daoen, of City of Industry, California
Updated May 28About 1,000 units
The recalled magnetic balls violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard…
Hazard. The recalled magnetic balls violate the mandatory standard for toys because they are loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, they can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and death.
What to do. Consumers should stop using the recalled magnet ball toys immediately, take them away from children and dispose of them.
Lil Pick Up Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or…
Lil Pick Up, of Rowland Heights, California
Updated May 21About 700 units
The recalled youth ATVs violate the federal mandatory ATV safety standard, posing a risk of serious injury or death. The youth ATVs fail to…
Hazard. The recalled youth ATVs violate the federal mandatory ATV safety standard, posing a risk of serious injury or death. The youth ATVs fail to meet mechanical suspension requirements, and the reverse indicator light fails to illuminate, posing a crash hazard. The parking brakes fail to hold, posing a collision hazard. Additionally, the surfaces near the footwell can reach high temperatures, posing a…
What to do
Consumers should stop using the recalled youth ATVs immediately and contact Lil Pick Up for a full refund
Consumers will be asked to go to www.lilpickup.us to register for the recall and receive instructions on how to return the recalled ATVs, which includes free ATV pick up and transportation
Superbobi Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from…
Remy&shop
Updated May 14About 200 units
The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing e…
Hazard. The recalled drain covers violate the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing entrapment and drowning hazards to swimmers and bathers.
What to do
Pool owners, pool operators and consumers should immediately stop using pools with the recalled pool drain covers
To receive a refund, consumers will be asked to remove the drain cover from the pool, destroy the drain cover, take a photo of the destroyed cover, and send it to Remy&shop by email at…
Minka Lighting Group Recalls Bardon Series Pendant Light Fixtures Due to Risk of Serious…
Minka Lighting Group, of Corona, California
Updated May 14About 170 units
The recalled light fixture's frame can detach from the pendant downrod during installation, posing a risk of serious injury or death from a…
Hazard. The recalled light fixture's frame can detach from the pendant downrod during installation, posing a risk of serious injury or death from an impact hazard.
What to do
Consumers should stop using the recalled Minka Bardon Series Pendant Light Fixtures immediately and contact Minka Lighting Group to receive a full refund in the form of a check sent by mail
Consumers should keep clear of the area directly beneath installed light pendants
Rainbow Wall Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard…
Online at Amazon.com from December 2025 through March 2026 for about $90.
Updated May 7About 160 units
The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone compone…
Hazard. The recalled toys violate the mandatory safety standard for children's toys because the drumstick that is attached to the xylophone component has a spherical end that can pose a choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact Justforjoyful for a full refund
Consumers will be asked to write "RECALLED" on the back of the individual wooden components, submit a photo of the marked pieces to [email protected], then di…
Natural Pigments Recalls Rublev Colours Gum Turpentine and Mineral Spirits Bottles Due to…
Natural Pigments, of Willits, California
Updated May 7About 860 units
The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant pa…
Hazard. The gum turpentine and mineral spirits contain turpentine and low-viscosity hydrocarbons, respectively, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottles are not child-resistant, posing a risk of serious injury or death from poisoning if the contents are swallowed by young children.
What to do
Consumers should secure the recalled bottles out of sight and reach of children immediately and contact Natural Pigments to receive a replacement product with child-resistant packaging or a refund
Consumers will be asked to submit a photo of the recalled product, provide contact information and co…
Multi-Purpose Helmets Recalled Due to Risk of Serious Injury or Death from Head Injury…
Online at Temu.com from August 2024 through February 2026 for between $9 and $11.
Updated May 7About 740 units
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stabil…
Hazard. The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the positional stability and certification requirements. The helmets can fail to protect the user in the event of a crash, posing a serious risk of injury or death due to head injury.
What to do
Consumers should stop using the recalled helmets immediately and contact Foubeaka or Geniuss for a full refund
Consumers will be asked to destroy the recalled helmet by cutting the straps and then send a photo of the destroyed helmet to the corresponding firm
EVLWZL and Gunugu Mattresses Recalled Due to Risk of Serious Injury or Death from Fire…
Amazon.com, Walmart.com and Wayfair.com from October 2025 through March 2026 for between $100 and $260. Platform Purcha…
Updated May 7About 670 units
The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattress immediately and contact EVLWZL for repair
Consumers will receive a free fitted cover to put over their mattress, which will bring the mattress into compliance with mandatory flammability standards
Analemma Water Bottles Recalled Due to Risk of Serious Injury or Death from Laceration…
Analemma
Updated May 7About 800 units
The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.
Hazard. The recalled water bottle's inner glass liner can break, posing a risk of serious injury or death from laceration and ingestion hazards.
What to do
Consumers should immediately stop using the recalled water bottles and contact New Earth Technologies d.o.o. for a full refund or a free repair, including shipping
The repair consists of a stainless-steel mesh insert and instructions on how to insert it into the water bottle
Allura Imports Recalls Youth Sweatshirts with Bobcat Logo and Drawstrings Due to Risk of…
Allura Imports, of New York, New York
Updated May 7About 120 units
The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sw…
Hazard. The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children from strangulation. The sweatshirts are in violation of the federal regulations for children's upper outerwear and present a substantial product hazard.
What to do
Consumers should take the recalled clothing away from children immediately, remove the drawstrings to eliminate the hazard and contact Allura Imports for a full refund
Consumers should contact [email protected], with subject 'RECALL', along with their name and the date, to receive a shipping la…
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III…
Olympus of the Americas
Updated Jun 5988700 units units
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Dista…
Hazard. Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather tha…
Hazard. Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2…
Insulet
Updated May 204,936,056 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…
Insulet
Updated May 201,790,784 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD…
Insulet
Updated May 20289,046 units units
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user reg…
Hazard. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most s…
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and…
Fresenius Medical Care Holdings
Updated May 11113,544 units (4,731 cases) units
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port …
Hazard. Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…
Datex-Ohmeda
Updated May 8550 (367 US; 183 OUS) units
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated…
Datex-Ohmeda
Updated May 8550 (367 US; 183 OUS) units
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that doe…
Hazard. Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Kith Retail Recalls Children's Loungewear Sets Due to Risk of Serious Injury from Burn…
Kith Retail of Brooklyn, New York
Updated Jun 25About 130 (In addition, nine in… units
The recalled children's loungewear sets violate the mandatory flammability standards for children's sleepwear, posing a risk of serious bur…
Hazard. The recalled children's loungewear sets violate the mandatory flammability standards for children's sleepwear, posing a risk of serious burn injuries.
What to do
Consumers should stop using the loungewear immediately and contact Kith Retail for a full refund
Consumers will be asked to destroy the pajamas by cutting them in half and to send a photo of the destroyed pajamas to [email protected] then dispose of the product
Kawasaki Motors USA Recalls Model Year 2026 Teryx4 H2 and Teryx5 H2 Recreational Off-Road…
Kawasaki Motors Manufacturing, U.S.A., of Lincoln, Nebraska
Updated Jun 11About 3,585 units
The drive converter sheave can break in certain circumstances, resulting in metal fragments being discharged within the engine compartment …
Hazard. The drive converter sheave can break in certain circumstances, resulting in metal fragments being discharged within the engine compartment and surrounding area, posing impact and injury hazards.
What to do
Consumers should stop using the recalled vehicles immediately and contact a Kawasaki dealer to schedule a free repair
A technician will replace the moveable clutch sheave assembly, install a clutch cover guard and reprogram the Engine Control Unit (ECU) on the vehicle
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, pr…
Hazard. Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…
Baxter Healthcare
Updated Jun 3024528 units units
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed…
Hazard. Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA
Updated Jun 2611226 units units
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the conn…
Hazard. A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the return path, leading to excessive pressure causing the cryoprobe to rupture.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this…
Hazard. If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous…
ICU Medical
Updated Jun 2439,750 units units
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inade…
Hazard. ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2411,720 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2413,510 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 2421,290 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…
Boston Scientific
Updated Jun 1174,760 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…
ICU Medical
Updated Jun 1012525 units units
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to …
Hazard. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior…
Hazard. Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior…
Hazard. Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Siemens Healthcare Diagnostics
Updated Jun 824,077 units units
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely d…
Hazard. The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Giantex Recalls Giantex and Costway Portable Steam Saunas Due to Burn Hazard
The recalled portable steam saunas were sold online at Amazon and Walmart from January 2023 through December 2025 for b…
Updated May 28About 1,000 units
The sauna's steam diffuser can be positioned too close to a consumer's body, allowing hot steam to come in contact with user, posing a burn…
Hazard. The sauna's steam diffuser can be positioned too close to a consumer's body, allowing hot steam to come in contact with user, posing a burn hazard.
What to do
Consumers should stop using the portable steam sauna immediately and contact Giantex for a full refund
Consumers will be asked to destroy the recalled portable steam sauna by cutting the cord to the steam unit after unplugging and submit a photograph of the destroyed product by email to support@gi…
Resistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym
HomeProGym (Singapore)
Updated May 21About 700 units
The recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury from impact hazard.
Hazard. The recalled resistance bands can forcefully separate from the handle during use, posing a risk of serious injury from impact hazard.
What to do
Consumers should stop using the recalled bands immediately and contact HomeProGym for a full refund or a $50 HomeProGym.com store credit
Consumers will be asked to destroy the purple 60-pound resistance and the gray 70-pound resistance bands by cutting them in half, send a photo of the destroyed b…
Giantex Recalls Lounge Chairs Due to Amputation Hazard
Giantex.com and Amazon.com from August 2023 through October 2025 for between $75 and $90.
Updated May 28About 1,155 units
Consumers can place their fingers in a pinch point, when adjusting the lounge chair, posing an amputation risk.
Hazard. Consumers can place their fingers in a pinch point, when adjusting the lounge chair, posing an amputation risk.
What to do
Consumers should stop using the recalled lounge chairs immediately and contact Giantex for a full refund
Consumers will be instructed to either request a prepaid return package or will be asked to destroy the recalled lounge chair by detaching the headrest pillow, cutting the fabric, and providing…
Amazon Recalls Amazon Basics 55 Lbs. Adjustable Dumbbells Due to Impact Hazard
Amazon.com Services, of Seattle, Washington
Updated May 14About 2,900 units
The weight plates can fail to engage completely during weight adjustment and dislodge from the dumbbell handle when used, posing an impact …
Hazard. The weight plates can fail to engage completely during weight adjustment and dislodge from the dumbbell handle when used, posing an impact hazard.
What to do
Consumers should stop using the recalled dumbbell immediately and follow Amazon's instructions for a full refund
Upon registration at https://amazondumbbellrecall.expertinquiry.com, consumers will be provided with a prepaid shipping label to return the dumbbell handle to Amazon
May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to sligh…
Hazard. May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.
VITEK 2 AST-N447 TEST KIT Product reference 424620
Biomerieux
Updated Jun 445,900 cards units
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch fo…
Hazard. Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-opera…
Hazard. Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 2116187 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH…
Medline Industries, LP
Updated May 2148075 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog…
Baxter Healthcare
Updated May 2113881 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 2110540 units units
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Abbott Medical
Updated May 1211182 programs units
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the…
Hazard. Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan…
B Braun Medical
Updated May 616,080 units units
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has …
Hazard. These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA
Updated May 618,444 units
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal c…
Hazard. Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP,…
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity I…
Hazard. Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity I…
Hazard. Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control…
MUNEVO
Updated Jun 1919 units
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexp…
Hazard. A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer…
Accuray
Updated Jun 1648 units units
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If pers…
Hazard. In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer…
Accuray
Updated Jun 16292 units units
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If pers…
Hazard. In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inap…
Hazard. Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Siemens Healthcare Diagnostics
Updated Jul 67018 units units
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) …
Hazard. Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c_E) results; Increased rate of reaction cuvette QC failures and Delayed results due to QC failures.
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to th…
Hazard. Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life. Reduced bleach concentration may compromise the effectiveness of disinfection, potentially allowing for the survival and persistence of pathogenic microorganisms.
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…
Contego Medical
Updated Jun 295069 units
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-fi…
Hazard. Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction; and if this condition were to occur during a procedure, the result may be loss of intended integrated embolic protection.
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an…
Medtronic Perfusion Systems
Updated Jun 243,621 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an…
Medtronic Perfusion Systems
Updated Jun 241,424 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…
Medtronic Perfusion Systems
Updated Jun 243,110 units units
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hy…
Hazard. Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lea…
Hazard. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack…
Windstone Medical Packaging
Updated Jun 173378 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Medtronic MiniMed
Updated Jun 163,465 units
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are ena…
Hazard. For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF…
Argon Medical Devices
Updated Jun 156928 units
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrient…
Hazard. Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…
Abiomed
Updated Jun 111,540 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU…
Medline Industries, LP
Updated Jun 111601 units units
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr…
Abiomed
Updated Jun 115,017 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…
Abiomed
Updated Jun 111,223 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
ICU Medical
Updated Jun 105059 units units
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to …
Hazard. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack…
Windstone Medical Packaging
Updated Jun 87306 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Spicy Breakfast Burrito sold under the following brand names: FRESH & READY FOODS Spicy…
M.G. Foods
Updated Jul 18498 burritos units
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is …
Hazard. Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 diss…
Hazard. Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets)…
Boehringer Ingelheim Pharmaceuticals
Updated Jun 12560 bottles units
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previousl…
Hazard. CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol…
PURPREP
Updated Jun 11N/A units
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were inste…
Hazard. Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL…
Medline Industries, LP
Updated May 289,272 kits units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B…
Medline Industries, LP
Updated May 289,272 kits units
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the …
Hazard. Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from t…
Hazard. Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2)…
Medline Industries, LP
Updated May 211,512 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…
Windstone Medical Packaging
Updated May 211080 kits units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in…
WALLAC OY
Updated May 183,274 units units
Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the r…
Hazard. Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca…
Boston Scientific
Updated May 129750 units units
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anti…
Hazard. Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent c…
Hazard. A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on…
Hazard. There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differin…
Atlan A350. Model Number: 8211500. anesthesia workstation
Draeger
Updated May 73,515 units units
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ven…
Hazard. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART…
Medline Industries, LP
Updated May 66775 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model…
Olympus of the Americas
Updated May 53,241 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Olympus of the Americas
Updated May 51,156 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Olympus of the Americas
Updated May 53,663 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
My Wife's Slaw, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands…
Jes Withrow
Updated May 510 individual units (TOTAL) units
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safet…
Hazard. Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.
My Wife's Slaw Jalapeno Heat, packaged in 8 oz. and 16 oz. glass mason jars with metal…
Jes Withrow
Updated May 510 individual units (TOTAL) units
Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safet…
Hazard. Product was manufactured and distributed without the benefit of an approved food establishment inspection and the required regulatory safety parameters could not be verified.
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim…
Straumann USA
Updated Jul 16175 units units
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length inst…
Hazard. Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the …
Hazard. There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
GE Medical Systems Information Technologies
Updated Jul 1011 units units
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient moni…
Hazard. A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or access to Protected Health Information (PHI).
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect platea…
Hazard. The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified surgery as the plateau cannot be inserted and an alternative product would be needed. If the incorrect plateau were to be implanted, this is associated with increased risk of wear, which could result in a reduced standin…
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection…
Spectra Medical Devices
Updated Jul 6TBD units
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised,…
Hazard. Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis…
IsoTis OrthoBiologics
Updated Jul 298 units
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine an…
Hazard. Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description…
Biomet
Updated Jul 111 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description…
Biomet
Updated Jul 122 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description…
Biomet
Updated Jul 110 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description…
Biomet
Updated Jul 112 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Aniara Diagnostica
Updated Jul 14 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Aniara Diagnostica
Updated Jul 19 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Aniara Diagnostica
Updated Jul 17 units units
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead t…
Hazard. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description…
Biomet
Updated Jul 126 units
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potentia…
Hazard. Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused by an exposed saw blade.
SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.
KENT IMAGING
Updated Jun 3077 units
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has f…
Hazard. The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shipping mode." When this occurs, an affected device will not resume charging when reconnected to power and becomes temporarily unusable/ unavailable for wound imaging until corrected.
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
GE Medical Systems Information Technologies
Updated Jun 29163 units units
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to…
Hazard. Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results wer…
Hazard. Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% post-reconstitution sodium azide concentration, with the worst outcome being mild skin or eye irritation and no serious harm…
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifi…
Hazard. Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…
Beckman Coulter
Updated Jun 26
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifi…
Hazard. Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…
Boston Scientific
Updated Jun 1968 units units
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or…
Hazard. Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended…
Ferno-Washington
Updated Jun 19278 units
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the w…
Hazard. Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Freudenberg Medical
Updated Jun 1740 units units
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box fo…
Hazard. Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Freudenberg Medical
Updated Jun 1712 units units
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box fo…
Hazard. Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part…
Windstone Medical Packaging
Updated Jun 17100 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX…
Windstone Medical Packaging
Updated Jun 1724 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part…
Windstone Medical Packaging
Updated Jun 1715 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray…
Windstone Medical Packaging
Updated Jun 17950 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that…
Hazard. Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin exposure can cause an acute inflammatory process.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part…
Windstone Medical Packaging
Updated Jun 1760 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single…
Windstone Medical Packaging
Updated Jun 17580 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part…
Windstone Medical Packaging
Updated Jun 1715 kits units
Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing …
Hazard. Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrient…
Hazard. Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life o…
Hazard. Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement…
Tosoh Bioscience
Updated Jun 12310 units units
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer…
Hazard. The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or …
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…
Abiomed
Updated Jun 11846 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and…
Boston Scientific
Updated Jun 11400 units units
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve d…
Hazard. Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve …
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline…
Medline Industries, LP
Updated Jun 11155 kits units
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with…
Hazard. Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…
Boston Scientific
Updated Jun 116 units units
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOIN…
Hazard. Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…
PHILIPS MEDICAL SYSTEMS
Updated Jun 11182 units
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tr…
Hazard. The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…
Abiomed
Updated Jun 11196 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…
Abiomed
Updated Jun 1196 units units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Hazard. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…
Orthofix U.S.
Updated Jun 1048 units units
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF…
Medline Industries, LP
Updated Jun 10163 kits units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breac…
Hazard. Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267
Medline Industries, LP
Updated Jun 10163 kits units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breac…
Hazard. Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device.
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and …
Hazard. Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, …
Hazard. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibilit…
Hazard. Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack…
Windstone Medical Packaging
Updated Jun 8927 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack…
Windstone Medical Packaging
Updated Jun 8919 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU…
Medline Industries, LP
Updated Jun 852 kits units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which we…
Hazard. The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF…
Micro Therapeutics
Updated Jun 813 units units
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm …
Hazard. Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF…
Micro Therapeutics
Updated Jun 86 units units
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm …
Hazard. Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw materi…
Hazard. Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU…
Medline Industries, LP
Updated Jun 8318 kits units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which we…
Hazard. The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part…
Windstone Medical Packaging
Updated Jun 8465 units units
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological S…
Hazard. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monit…
Hazard. Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5…
BUDESONIDE
Updated May 29N/A units
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and …
Hazard. Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the prop…
Hazard. Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the prop…
Hazard. Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
Optima XR200amx, Mobile Digital-Ready Radiographic System
GE Medical Systems
Updated Jun 54 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochl…
Hazard. Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a …
Optima XR240amx, Mobile Digital Radiographic System
GE Medical Systems
Updated Jun 524 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
Optima XR220amx, Mobile Digital-Ready Radiographic System
GE Medical Systems
Updated Jun 538 units units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional tes…
Hazard. GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column tra…
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Integra LifeSciences (NeuroSciences)
Updated Jun 5633 units units
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time…
Hazard. The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following…
Philips North America
Updated Jun 5909 units units
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resu…
Hazard. Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI…
Maquet Cardiovascular
Updated Jun 2205 units units
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a …
Hazard. Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Argon Medical Devices
Updated Jun 1850 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria f…
Hazard. Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a…
Emano Metrics
Updated May 29685 units
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 H…
Hazard. Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, an…
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY…
Medline Industries, LP
Updated May 2875 kits units
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART…
Medline Industries, LP
Updated May 28396 kits units
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific produ…
Hazard. Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops del…
Hazard. A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. T…
Hazard. Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designat…
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Inter-Med
Updated May 27500 units
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and c…
Hazard. Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting.
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Philips North America
Updated May 26285 units units
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk…
Hazard. Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Philips North America
Updated May 26169 units units
Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk…
Hazard. Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Innovasis
Updated May 225 units
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion …
Hazard. Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with undersized condition which could prevent mating tip from engaging with the pedicle screw tulip and rod during tightening, which may lead to surgical delay, intervention/alternative methods to perform final tightening step.
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible…
W L Gore & Associates
Updated May 2213 units units
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without trans…
Hazard. 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible…
W L Gore & Associates
Updated May 2213 units units
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without trans…
Hazard. 10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and …
Hazard. Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008…
Instrumentation Laboratory
Updated May 2132 units units
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established man…
Hazard. The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010…
Instrumentation Laboratory
Updated May 21109 units units
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing spe…
Hazard. The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single…
Karl Storz Endoscopy
Updated May 2145 units
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endosco…
Hazard. Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2)…
Medline Industries, LP
Updated May 21333 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Medline Industries, LP
Updated May 21176 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical…
Windstone Medical Packaging
Updated May 21200 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p…
Laborie Medical Technologies
Updated May 21372 units units
Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside…
Hazard. Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system's internal tubing or at the hydrophobic filter and waterproof pressure sensors. Accumulated moisture may affect airflow or pressure measurement performance if not properly removed.
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2)…
Medline Industries, LP
Updated May 21512 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND…
Medline Industries, LP
Updated May 21250 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Medline Industries, LP
Updated May 21180 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical…
Windstone Medical Packaging
Updated May 21200 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical…
Windstone Medical Packaging
Updated May 2145 units units
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus p…
Hazard. Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
Medline Industries, LP
Updated May 21270 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
Medline Industries, LP
Updated May 21420 kits units
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently bein…
Hazard. Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number…
Baxter Healthcare
Updated May 21
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage …
Hazard. There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons …
Hazard. The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a no…
Hazard. Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a no…
Hazard. Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.
Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.
AVID Medical
Updated May 19112 kits units
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlu…
Hazard. Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S
Updated May 18400 units units
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment…
Hazard. The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring of renal disease in intended users.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Abiomed
Updated May 1810 units units
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss o…
Hazard. Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St…
Medline Industries, LP
Updated May 153 units
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual p…
Hazard. Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or …
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Alphatec Spine
Updated May 133 units
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) fu…
Hazard. Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has …
Hazard. Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood circulation and become lodged within blood vessels.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Octopus Evolution AS Tissue Stabilizer, Model TS2500
Medtronic Perfusion Systems
Updated May 12288 units units
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short t…
Hazard. During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class…
Hazard. Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for device. Improperly labeled - omitted labels required under 21 CFR 1040.10 / IEC 60825-1 via LN#56. Missing certification and proper manufacturer's ID label. Was not accompanied by compliant User Information. Formalized…
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead…
Inspire Medical Systems
Updated May 1110 impacted units units
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material d…
Hazard. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead…
Inspire Medical Systems
Updated May 1150 impacted units units
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material d…
Hazard. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 867 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 827 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 821 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…
Instrumentation Laboratory
Updated May 83 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with…
Instrumentation Laboratory
Updated May 8122 units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3…
Instrumentation Laboratory
Updated May 84 US units
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an inc…
Hazard. Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Ventec Life Systems
Updated May 81 units
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup ala…
Hazard. Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE Medical Systems SCS
Updated May 8340 servers units
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the A…
Hazard. GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error …
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.…
Hazard. User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information
Atlan A350XL. Model Number: 8621600. anesthesia workstation
Draeger
Updated May 7394 units units
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ven…
Hazard. The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2)…
Medline Industries, LP
Updated May 6233 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)…
Medline Industries, LP
Updated May 6503 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2)…
Medline Industries, LP
Updated May 6227 units units
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride …
Hazard. The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune…
Stryker
Updated May 61 unit units
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have compl…
Hazard. It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Fresenius Kabi USA
Updated May 632 systems units
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion a…
Hazard. Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Olympus of the Americas
Updated May 5190 units units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer…
Hazard. Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
