Joolz Recalls Aer2 Car Seat Adapters for Strollers Due to Risk of Serious Injury from…
Joolz USA, of New York, New York
Updated 2 days agoAbout 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
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 2 days agoAbout 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…
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
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…
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 2 days agoAbout 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 2 days agoAbout 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 2 days agoAbout 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 2 days agoAbout 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 2 days agoAbout 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…
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…
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…
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 2 days agoAbout 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 2 days agoAbout 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
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…
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.
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…
Build-A-Bear Workshop Recalls Heartwarming Hugs Bears Due to Risk of Serious Injury or…
Build-A-Bear Workshop, of St Louis, Missouri
Updated Apr 30About 36,000 (In addition 520 w… units
The zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to children.
Hazard. The zipper slider on the side pouch can detach, posing a risk of serious injury or death from choking hazard to children.
What to do. Consumers should immediately stop using the recalled Heartwarming Hugs Bear and return it to a local Build-A-Bear Workshop store to receive a refund in the form of original payment or a gift card for the original purchase price redeemable toward any available Make-Your-Own furry friend and any othe…
Generac Power Systems Recalls Portable Generators Due to Risk of Serious Injury or Death…
Home Depot, Lowe's and other home improvement and hardware stores nationwide and online from May 2025 through February …
Updated Apr 16About 149,400 (In addition, abo… units
When first filling the recalled generator with gasoline, fuel can leak from the carburetor, posing a risk of serious injury or death from f…
Hazard. When first filling the recalled generator with gasoline, fuel can leak from the carburetor, posing a risk of serious injury or death from fire or burn hazard. Consumers with generators that have previously been filled with enough gasoline to move the gauge off "E," or have been used without any gasoline leakage, can continue to be used.
What to do
Consumers should immediately stop using the recalled Generac portable generator and go to https://www.generac.com/about/recalls/GP-Carburetor to check to see if your model and serial number are included in this recall
If your unit is included in the recall and has either not yet been filled with f…
Apex Gaming PCs Recalls Manik and Apex-branded ATX Computer Power Supplies Due to Risk of…
Apex Gaming PCs, of Houston, Texas
Updated Apr 16About 17,730 (In addition, abou… units
The units lack a permanent, on-product warning label identifying potential electrical shock and electrocution hazards, posing a risk of ser…
Hazard. The units lack a permanent, on-product warning label identifying potential electrical shock and electrocution hazards, posing a risk of serious injury or death if the unit is opened or disassembled.
What to do. Consumers should stop using the recalled computer power supplies immediately and contact Apex Gaming PCs Inc. for a free repair in the form of one permanent, UL-recognized, heat-resistant adhesive safety label containing an ANSI-compliant "Danger/Warning" shock hazard and "No User-Serviceable Parts…
Vitaquest International Recalls Multiple Iron Supplement Bottles and Packets Due to Risk…
Vitaquest International of West Caldwell, New Jersey
Updated Apr 9About 356,140 units
The dietary supplements contain iron, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The pa…
Hazard. The dietary supplements contain iron, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The packaging of the supplements is 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 immediately store the supplements out of sight and reach of children and contact Vitaquest International for information on how to obtain a free child-resistant replacement cap or storage pouch
Brand / Product Name Remedy Arey Not Today, Grey (60ct and 180ct) Cap Bari Life Complet…
SCUBAPRO Recalls Monorail Weight Pockets for Buoyancy Compensator Devices (BCDs) Due to…
Johnson Outdoors Diving d/b/a SCUBAPRO, of Racine, Wisconsin
Updated Apr 9About 2,800 (In addition, about… units
The D-ring handle that is used to unlock the weight pocket from the Buoyancy Compensator Device (BCD) can detach during use. If this happen…
Hazard. The D-ring handle that is used to unlock the weight pocket from the Buoyancy Compensator Device (BCD) can detach during use. If this happens, the user will not be able to remove the weight pocket in an emergency, in order to rise to the surface, posing a risk of serious injury or death from a drowning hazard.
What to do. Consumers should immediately stop using the recalled Monorail Weight Pocket and register online at https://scubapro.johnsonoutdoors.com/us/recalls for a free repair of the D-ring handle at a local authorized dealer or to obtain a prepaid shipping label to return the recalled weight pocket to SCUBAP…
Sangohe Reannounces and Expands Adult Portable Bed Rails Recall Due to Risk of Serious…
Zhongshan KDB Health Solutions (China)
Updated Apr 2About 36,500 (In January 2026, … 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 warning labels.
What to do
Consumers should immediately stop using the recalled adult portable bed rails and contact Sangohe for a full refund
Consumers should destroy the bed rails by cutting the handrails' foam padding and writing "RECALLED" on the upper and lower rails with permanent marker, take a photo of the destroyed…
Vive Health Recalls Adult Portable Bed Rails Due to Risk of Serious Injury or Death from…
Vive Health, of Naples, Florida
Updated Mar 26About 122,000 units
When the recalled bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of t…
Hazard. When the recalled bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
What to do
Consumers should stop using the recalled Vive Health Bed Rails immediately and contact Vive Health for a full refund
Consumers should write "RECALLED" on the upper and lower portions of the bed rails with permanent marker and take a photo of the marked bed rail with the buyer's name on a piece of …
AirClub Convertible Bassinets Recalled Due to Risk of Serious Injury or Death from Fall…
Online at Amazon.com from October 2023 through December 2025 for between $110 and $130.
Updated Mar 26About 110,400 units
The recalled convertible bassinets violate the mandatory standard for bedside sleepers because the mechanism used to attach the product to …
Hazard. The recalled convertible bassinets violate the mandatory standard for bedside sleepers because the mechanism used to attach the product to the adult bed creates an opening between the bedside sleeper and mattress, posing a deadly fall hazard to infants.
What to do
Consumers should stop using the recalled AirClub convertible bassinets immediately and contact AirClub for a replacement attachment mechanism
Consumers will be asked to cut off the two original L-shape straps, throw them away and follow the instructions provided to install the new four straps with…
4our Kiddies Tip Restraint Kits Recalled Due to Tip-Over Hazard; Risk of Serious Injury…
Shenzhen City Donglin E-Commerce d/b/a 4our Kiddies (China)
Updated Mar 26About 253,500 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 that can result in serious injuries or death to children or elderly consumers interacting with furniture that is secured to the wall with the defective plastic tip restraints. This is a hidden defect because consumers who purchase and install this product may…
What to do
Consumers should stop using 4our Kiddies plastic tip restraints immediately and contact 4our Kiddies for a free replacement tip restraint kit made of stainless steel
Consumers should keep children away from the unit while waiting for a replacement tip restraint kit and should dispose of the recall…
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
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.
Kroger HOMESTYLE Cheese AND Garlic CROUTONS NET WT 5 OZ (141g) UPC 0 11110 81353 4…
Sugar Foods
Updated Apr 2713,739cs/12/5oz pouches units
Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was r…
Hazard. Possible Salmonella in croutons. The firm was notified by their supplier that the non-fat milk powder used to manufacture the product was recalled due to possible salmonella.
Stoney Games Recalls Kluster Magnet Chess Games Due to Risk of Serious Injury or Death…
Stoney Games of Bexley, Ohio
Updated Mar 12About 151,600 units
The recalled magnet games violate the mandatory standard for toys because they contain loose high-powered magnets that fit within CPSC's sm…
Hazard. The recalled magnet games violate the mandatory standard for toys because they contain loose high-powered magnets that fit within CPSC's small parts cylinder, 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/…
What to do. Consumers should immediately stop using the recalled magnet games, take them away from children and contact Stoney Games for instructions on how to dispose of the recalled magnets and receive replacement magnets that are not small parts.
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…
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…
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…
Bayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury…
Bayer HealthCare, of Whippany, New Jersey
Updated Apr 30About 786,100 units
The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complyin…
Hazard. The 6 mL nasal sprays contain an imidazoline, which must be in child-resistant packaging or meet the labeling requirements for non-complying packaging, as required by the Poison Prevention Packaging Act. The 6 mL nasal spray's packaging is not child-resistant nor bears the required labeling statement, posing a risk of serious injury or illness from poisoning, if the contents are swallowed by youn…
What to do
Consumers should immediately secure the recalled bottles out of sight and reach of children and go to the webform posted on www.livewell.bayer.com/afrin-original-spray-recall to begin a request for a refund
Consumers will be asked to take and submit a photo of the product before disposing of it in…
Acer America Corporation Recalls Two-Wheeled Folding Electric Due to Risk of Injury from…
Acer America, of Irvine, California
Updated Apr 30About 510 (In addition, about 3… units
A loose screw can cause the front tube to fold down unexpectedly, posing a risk of injury from a fall hazard.
Hazard. A loose screw can cause the front tube to fold down unexpectedly, posing a risk of injury from a fall hazard.
What to do
Consumers should stop using the recalled folding electric scooter immediately and contact Acer at https://www.acer.com/us-en/support/alerts-recalls for instructions on how to tighten the screw
Free repair tools will be available to consumers upon request
32 Degrees Recalls Heated Socks Due to Burn Hazard
David Peyser Sportswear d/b/a 32 Degrees, of New York, New York
Updated Apr 23About 207,806 units
When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can po…
Hazard. When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard including burns.
What to do. Consumers should immediately stop using the heated socks and return them to Costco for a full refund.
Head USA Recalls Ski Boots Due to Risk of Serious Injury from Fall Hazard
Head USA, of Boulder, Colorado
Updated Apr 9About 1,365 (In addition, about… units
The fluorescent yellow materials of the boot shell and sole inserts can deteriorate and break, posing a risk of serious injury from a fall.
Hazard. The fluorescent yellow materials of the boot shell and sole inserts can deteriorate and break, posing a risk of serious injury from a fall.
What to do
Consumers should stop using the recalled ski boots immediately and contact Head USA or a Head authorized retailer
For recalled boots with fluorescent boot shell materials, Head will provide free replacement boots in a newer equivalent model upon return of the recalled boots
BISSELL Recalls Over One Million Steam Shot OmniReach Steam Cleaners Due to Risk of…
BISSELL Homecare of Grand Rapids, Michigan
Updated Apr 9About 1.7 million (In addition,… units
The recalled steam cleaners' attachments can unexpectedly detach from the steam cleaners and expel hot water or steam onto users during use…
Hazard. The recalled steam cleaners' attachments can unexpectedly detach from the steam cleaners and expel hot water or steam onto users during use, posing a serious burn hazard.
What to do
Consumers should stop using the recalled steam cleaner attachments immediately and contact BISSELL to receive free new attachments
Consumers should visit www.steamshot2026.com to register for the recall and for instructions on how to participate in the recall, including how to upload a photo showi…
E Mishan Recalls Granitestone Diamond Pro Blue Stainless Sauté Pans Due to Impact and…
E Mishan & Sons, of New York, New York
Updated Apr 2About 740,000 units
The metal cap on the screw that connects the sauté pan to the handle can become detached and forcefully eject when heated, posing impact an…
Hazard. The metal cap on the screw that connects the sauté pan to the handle can become detached and forcefully eject when heated, posing impact and burn hazards to consumers.
What to do
Consumers should stop using the recalled sauté pans immediately and contact E Mishan for a full refund
Consumers will be asked to return the recalled sauté pan
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…
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
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
Segmart 4-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over…
Online at Walmart from January 2025 through March 2026 for about $80.
Updated Apr 30About 16,440 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 immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access
Contact SOFT for instructions on how to identify affected units and dispose of the dressers to receive a full refund
American Honda Motor Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death…
American Honda Motor, of Torrance, California
Updated Apr 30About 12,600 (In addition, abou… units
The handlebar's clamp can unexpectedly cause the handlebar to rotate, posing a risk of serious injury or death due to a crash hazard.
Hazard. The handlebar's clamp can unexpectedly cause the handlebar to rotate, posing a risk of serious injury or death due to a crash hazard.
What to do. Consumers should stop using the recalled off-road motorcycles immediately and contact an authorized Honda Powersports dealer to schedule an appointment for a free inspection and if necessary, a replacement of the handlebar's clamp at the dealer's location.
Alliance Chemical Recalls 1-K Kerosene Heater Fluid Containers Due to Risk of Serious…
Alliance Chemical, of Taylor, Texas
Updated Apr 30About 30,155 units
The pre-filled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devic…
Hazard. The pre-filled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable kerosene fuel containers to be child-resistant. The container is not child-…
What to do
Consumers should stop using the recalled fuel containers immediately, place them out of reach of children and contact Alliance Chemical for a full refund
Consumers will be asked to provide a dated photo of the product and dispose of the fuel following local hazardous waste procedures
Autobrush Recalls Sonic Pro Children's Toothbrush Boxes Due to Risk of Serious Injury or…
Autobrush
Updated Apr 23About 48,000 units
The recalled delivery boxes violate the mandatory standard for consumer products containing button cell and coin batteries because they con…
Hazard. The recalled delivery boxes violate the mandatory standard for consumer products containing button cell and coin batteries because they contain a lithium coin battery that can be easily accessed by children, posing an ingestion hazard. The packaging also does not bear the required warning labels for products containing such batteries as required by Reese's Law. If button cell or coin batteries ar…
What to do
Consumers should stop using the boxes for the toothbrushes immediately, take them away from children and contact Autobrush for a $5 refund in the form of store credit
Consumers will be asked to write "Recalled" with permanent marker on the box and send a photo of the marked box to recall-support@a…
ZMC Group Recalls LED Finger Beam Lights Due to Risk of Serious Injury or Death from…
ZMC Group of Los Angeles, California
Updated Apr 16About 14,400 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 take the LED Finger Beam Lights away from children, stop using them immediately and contact ZMC Group for full refund or a replacement product
Consumers should remove the batteries, break each component in half and submit a photo of the destroyed pieces to [email protected]. …
Montessori Toy Sets Recalled Due to Risk of Serious Injury or Death from Choking Hazard…
Online at Amazon.com from October 2023 through November 2025 for about $30.
Updated Apr 16About 21,900 units
The Montessori toy sets contain an airplane shaped teething toy that has tentacle ends that can pose a choking hazard to young children. Th…
Hazard. The Montessori toy sets contain an airplane shaped teething toy that has tentacle ends that can pose a choking hazard to young children. The toys also violate the teething toy provision of the mandatory standard for children's toys.
What to do
Consumers should stop using the Montessori toy sets immediately and take them away from children and contact SpringFlower for a free replacement part or a refund
Consumers will be asked to cut off all the tentacles from the airplane shaped teething toy, write the date and customer's initials in pe…
JC Sales Recalls Lil' Buddies Pet Laser Toys Due to Risk of Serious Injury or Death from…
JC Sales
Updated Apr 16About 51,160 units
The Montessori toy sets contain an airplane shaped teething toy that has tentacle ends that can pose a choking hazard to young children. Th…
Hazard. The Montessori toy sets contain an airplane shaped teething toy that has tentacle ends that can pose a choking hazard to young children. The toys also violate the teething toy provision of the mandatory standard for children's toys.
What to do
Consumers should stop using the recalled pet toys, place them in an area that children cannot access and properly dispose of the batteries
Contact JC Sales for a full refund
Customers will be asked to email a photograph of the disposed items to [email protected]
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
ZOLIQUEX (China)
Updated Apr 16About 16,000 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 adult portable bed rails immediately and contact ZOLIQUEX for a full refund
Consumers should 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 with the buyer…
Magnetic Drinkware Charms Recalled Due to Risk of Serious Injury or Death from Magnet…
Maitys (China)
Updated Apr 9About 16,400 units
The recalled magnetic drinkware charms violate the mandatory standard for magnets because they contain loose magnets posing an ingestion ha…
Hazard. The recalled magnetic drinkware charms violate the mandatory standard for magnets because they contain 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 poiso…
What to do
Consumers should stop using the recalled drinkware charms immediately, take them away from children and contact Maitys for a full refund
Consumers will be asked to dispose of the charms and send a photo of the disposed product to [email protected]
Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Zhongshan Yungu Daily Products (China)
Updated Apr 9About 19,000 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 ZFZG-US for a full refund
Consumers should destroy the bed rail by cutting the storage bag off the upper rail and the safety strap in half, write "Recalled" in permanent marker on the main frame and upload a photo of the ma…
Sunnyyes LED Mini Lights Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from March 2024 through March 2026 for about $20.
Updated Mar 26About 26,000 units
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because the lights co…
Hazard. The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because the lights contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the screw used on the remote controls to secure the battery compartments that contain a lithium coin battery does not remain attached. Also, the pac…
What to do
Consumers should stop using the recalled LED lights immediately and place them in an area where children cannot access them
Consumers will be asked to disassemble and submerge all components in water
To receive a full refund, consumers will be asked to email a photo of the submerged product to us…
DIY Cold Plunge Recalls Sauna Heater Kits Due to Risk of Serious Injury or Death from…
Plunge Buddy, doing business as DIY Cold Plunge, of North Mankato, Minnesota
Updated Mar 26About 675 (In addition, about 1… units
Electrical conductors within the sauna heater kits can overheat, posing a fire hazard and risk of serious injury or death.
Hazard. Electrical conductors within the sauna heater kits can overheat, posing a fire hazard and risk of serious injury or death.
What to do
Consumers should stop using the recalled Sauna Heater Kit immediately and register at www.diycoldplunge.com/pages/recall for a full refund
Consumers will be asked to submit written and photo proof that the product has been destroyed/disposed of or request a prepaid shipping label to return the pro…
Wagner Spray Tech Recalls 900 Series Power Steamers Due to Burn Hazard
Wagner Spray Tech of Plymouth, Minnesota
Updated Mar 19About 700,000 (In addition, abo… units
The attached hose can get excessively hot and the nozzle/gun can expel hot water during use and after the trigger is engaged, posing a seri…
Hazard. The attached hose can get excessively hot and the nozzle/gun can expel hot water during use and after the trigger is engaged, posing a serious burn hazard to consumers.
What to do. Consumers should stop using the recalled steamers immediately and contact Wagner for a free repair kit, consisting of a hose sleeve, nozzle cover and funnel.
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…
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.
Samson International Recalls Bellevue and Oaklynn Canopy Bed Frames Due to Impact and…
Samson International, of High Point, North Carolina
Updated Apr 2About 5,600 (In addition, about… units
The canopy beams of the bed frames can collapse primarily when the bed is moved, posing impact and injury hazards to consumers.
Hazard. The canopy beams of the bed frames can collapse primarily when the bed is moved, posing impact and injury hazards to consumers.
What to do. Consumers should not move the recalled bed frames and contact Samson International immediately for a free repair and installation kit consisting of four metal brackets and mounting hardware.
Lifetime Brands Recalls BUILT LUUM Light Up Tumblers Due to Risk of Choking and Battery…
Lifetime Brands, owner of the BUILT brand, of Garden City, New York
Updated Mar 19About 75,700 units
The recalled LED tumblers can break, making the button cell batteries accessible to children and posing choking and ingestion hazards. When…
Hazard. The recalled LED tumblers can break, making the button cell batteries accessible to children and posing choking and ingestion hazards. 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 tumblers immediately, place them in an area that children cannot access and properly dispose of the battery
Contact Lifetime Brands for a full refund
Consumers will be asked to throw the piece with the LED light away and upload a photo of the product in th…
Tomum Minoxidil Hair Serum Spray Bottles Recalled Due to Risk of Serious Injury or Death…
Online at Amazon.com from March 2025 through September 2025 for about $20.
Updated Mar 5About 27,400 units
The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair …
Hazard. The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's 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 serum bottles out of sight and reach of children immediately and contact Belleka for a free replacement product, including two child-resistant bottles of serum (60 mL per unit)
Consumers will be asked to dispose of the recalled product bottle and send a photo o…
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.
Tzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to…
Tzumi Electronics of New York, New York
Updated Apr 23About 50,000 units
Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard.
Hazard. Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard.
What to do
Consumers should immediately stop using the adjustable dumbbell and contact Tzumi Electronics for a free replacement of the dumbbell and tray
Consumers should write the word "Recalled" across the dumbbell tray using permanent spray paint or marker, register at https://myfitrx.com/recall-52-lbs/ an…
Free-Standing Professional Gas Ranges Recalled Due to Risk of Burn Hazard; Manufactured…
Fisher & Paykel Appliances (Thailand) (Thailand)
Updated Apr 16About 433 (In addition, about 7… units
The ovens in the ranges can experience a delayed ignition, causing gas to accumulate and the oven door to open from combustion, posing a bu…
Hazard. The ovens in the ranges can experience a delayed ignition, causing gas to accumulate and the oven door to open from combustion, posing a burn hazard to users.
What to do
Consumers should stop using the ovens in the recalled gas ranges immediately and contact Fisher & Paykel for a free inspection and repair
Fisher & Paykel will provide professional in-home repair of the oven's ignitor
Consumers can continue to use the cooktop burners on the range
Sam's Club Recalls Member's Mark Children's Pajama Sets Due to Burn Hazard; Violates…
Hansoll Textile (South Korea)
Updated Apr 2About 18,000 units
The recalled pajama sets violate the mandatory standards for flammability of children's sleepwear, posing a risk of burn injuries to childr…
Hazard. The recalled pajama sets violate the mandatory standards for flammability of children's sleepwear, posing a risk of burn injuries to children.
What to do
Consumers should immediately stop using the recalled pajama sets, take them away from children and contact Sam's Club for information on how to receive a full refund
Consumers will be asked to return the product to their local store or to destroy the pajamas by cutting them in half and send a phot…
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…
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]
Qumeney Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from March 2024 through February 2026 for between $7 and $10 (6-pack) and between $15 and $18 (24-…
Updated Apr 30About 2,800 units
The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain b…
Hazard. The recalled bicycle lights 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. Additionally, the bicycle lights 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 bicycle lights immediately and contact Smfanlus for a full refund
Consumers will be asked to remove and properly dispose of the batteries and send a photo of the destroyed pieces of the light components to [email protected] to receive a…
Malker Bicycle Light Sets Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from October 2025 through November 2025 for between $7 and $10.
Updated Apr 30About 7,000 units
The recalled bicycle lights violate the mandatory standard for consumer products with button cell and coin batteries because they contain b…
Hazard. The recalled bicycle lights 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. Additionally, the bicycle lights 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 bicycle lights immediately and contact MalkerDirect for a full refund
Consumers should throw the bicycle lights away and send a photo of the product in the trash to [email protected]
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
Mobility Source Medical Technology of China
Updated Apr 30About 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 structural stability or retention strap requirements, posing a fall hazard. The bed rails' push pins and p…
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact Hepo Care Medical Equipment Online for a full refund
Consumers will be asked to destroy the bed rails by dismantling the bed rails, cutting off the storage bag and writing "RECALLED" on the upper and lower ra…
5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
UHOMEPRO (China)
Updated Apr 30About 5,190 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 immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access
Contact UHOMEPRO for instructions on how to identify affected units and dispose of the dressers to receive a full refund
Wiifo Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from…
Wiifo (China)
Updated Apr 23About 9,700 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 tower's sides, pos…
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 tower's 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 contact Wiifo for a full refund
Consumers will be asked to destroy the stool by disassembling it and send a photo of the destroyed stool to [email protected]
Consumers should then dispose of the destroyed product
mGanna Sodium Hydroxide Pellet Bags Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from November 2024 through March 2026 for about $10.
Updated Apr 23About 3,240 units
The recalled products contain sodium hydroxide (lye), which must be in child-resistant packaging as required by the Poison Prevention Packa…
Hazard. The recalled products contain sodium hydroxide (lye), which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child-resistant, posing a risk of chemical burns and irritation to the skin and eyes. The products also violate the labeling requirements for hazardous substances under the Federal Hazardous Substances Act (FHSA).
What to do
Consumers should stop using and secure the recalled sodium hydroxide product out of sight and reach of children immediately and contact Archie Xpress for a full refund
Consumers will be asked to write "RECALLED" on the back of the zip-top pouch and send a photo of the marked pouch to support@archi…
KMUYSL Big Red Barn Farm Animal Playsets Recalled Due to Risk of Serious Injury or Death…
Online at Amazon.com from July 2023 through June 2025 for about $20.
Updated Apr 233000 units
The recalled children's toys violate the small parts ban because the toy is intended for children under three years of age and the fence ha…
Hazard. The recalled children's toys violate the small parts ban because the toy is intended for children under three years of age and the fence handles can detach from the toy, posing a deadly choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact MISSJUNE for a full refund
Consumers will be asked to remove and properly dispose of the fence handles into the trash and send a photo of the disposed product to [email protected] to …
Cpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation…
Online at Amazon.com from October 2025 through November 2025 for about $50.
Updated Apr 23About 2,100 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 will then email photos of the destroyed pieces [email protected]…
Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment…
TOETOL HOME (China)
Updated Apr 23About 3,000 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 tower's sides, posi…
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 tower's sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should immediately stop using the recalled tower stools and contact TOETOL HOME for a full refund
Consumers will be asked to destroy the stool by disassembling it and send a photo of the destroyed stool to [email protected]
Sweetcrispy Recalls Pressure Washers Due to Serious Risk of Injury or Death from Shock…
Online at Amazon.com from July 2025 through January 2026 for between $60 and $130.
Updated Apr 162300 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Sweetcrispy for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord and send a photo of the destroyed power washer to [email protected]
Sanlebi Pet Vet Playsets Recalled Due to Risk of Serious Injury or Death from Battery…
Guangzhou Letao Keji Youxiangongsi, doing business as Letokids (China)
Updated Apr 16About 4,650 units
The Pet Vet Playset violates the mandatory standard for toys because the button cell batteries in the nail grinder and otoscope can be easi…
Hazard. The Pet Vet Playset violates the mandatory standard for toys because the button cell batteries in the nail grinder and otoscope can be easily accessed by children.
What to do
Consumers should take away the nail grinder and otoscope from children immediately, stop using them and remove and properly dispose of the batteries
Consumers will be asked to throw the nail grinder and otoscope components away and send a photo of the disposed components to [email protected] …
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
Patoolio Direct (China)
Updated Apr 162066 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Patoolio Direct for a full refund
Consumers will be asked to destroy the pressure washer by cutting the power cord in half and send a photo of the destroyed power washer to [email protected]
Mini Round Toddler Trampolines Recalled Due to Strangulation Hazard; Risk of Serious…
Shenzhen Segmart Technology Electronics (China)
Updated Apr 16About 1,200 units
Young children can become entangled in the straps of the hammock, punching bag and hand ring accessories, posing a strangulation hazard, wh…
Hazard. Young children can become entangled in the straps of the hammock, punching bag and hand ring accessories, posing a strangulation hazard, which can result in serious injury or death.
What to do
Consumers should remove the hammock, punching bag, hand ring and basketball board accessories immediately before continuing to use the trampoline
SEGMART will provide a $30 refund to consumers who remove and destroy the hammock, punching bag, hand ring and basketball board accessories
Le Hao Tool Recalls Pressure Washers Due to Serious Risk of Injury or Death from Shock…
Online at Amazon.com from November 2023 through January 2026 for between $60 and $130.
Updated Apr 163100 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Le Hao Tool 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]
Silks Recall Children's Loungewear Sets Due to Risk of Serious Injury or Death from Burn…
Online at Silksdesign.com from January 2024 through September 2025 for between $40 and $50.
Updated Apr 9About 7,900 units
The recalled children's loungewear violates mandatory flammability standards for children's sleepwear, posing a risk of serious injuries or…
Hazard. The recalled children's loungewear violates mandatory flammability standards for children's sleepwear, posing a risk of serious injuries or deadly burn hazards to children.
What to do
Consumers should immediately stop using the recalled loungewear, take it away from children and contact Silks for a full refund or store credit
Consumers should destroy the garments by cutting the top and bottom in half and send a photo of the destroyed garments to [email protected]
Prestige Import Group Recalls Supernova and Typhoon Lighters Due to Risk of Serious…
Prestige Import Group, of Deerfield, Florida
Updated Apr 9About 4,300 units
The recalled lighters violate the mandatory standard for cigarette lighters because they do not have the required child-resistant mechanism…
Hazard. The recalled lighters violate the mandatory standard for cigarette lighters because they do not have the required child-resistant mechanism, 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 a…
What to do
Consumers should stop using the recalled lighters immediately and contact Prestige Import Group for a full refund or store credit
Consumers will be asked to write "Recalled" in permanent marker and send a photo of the marked lighter to [email protected]
LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion…
Online at Amazon.com from March 2024 through February 2026 for about $20.
Updated Apr 9About 2,800 units
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain …
Hazard. The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings as required by Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause ser…
What to do
Consumers should stop using the recalled LED lights immediately and place them in an area where children cannot access them
Consumers will be asked to disassemble the lights and submerge all of the components in water
To receive a full refund, email a photo showing the submerged product to usa@ha…
Tuymec Minoxidil Hair Growth Spray Bottles Recalled Due to Risk of Serious Injury or…
Online at Amazon.com from June 2025 through August 2025 for about $24.
Updated Apr 2About 6,200 units
The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair …
Hazard. The hair serum contains minoxidil, which must be in child-resistant packaging as required by the Poison Prevention Packaging Act. The hair serum's packaging is 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 serum bottles out of sight and reach of children immediately and contact DrHealBeauty for a free empty replacement bottle with a child-resistant closure into which consumers should transfer the recalled bottle's contents.
HTRC and Haisito T400 Battery Chargers Recalled Due to Risk of Serious Injury and Death…
Huizhou Haitan Technology (China)
Updated Apr 2About 4,800 units
The chargers can ignite or cause a connected battery to ignite, posing a fire hazard and risk of serious injury and death.
Hazard. The chargers can ignite or cause a connected battery to ignite, posing a fire hazard and risk of serious injury and death.
What to do
Consumers should immediately stop using the recalled chargers and contact Huizhou Haitan Technology for instructions on how to return the chargers for a full refund
Consumers will be instructed to contact the firm to request a prelabeled and prepaid return package to be sent to them so they can re…
Coluans Christmas Light-Up Rings Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2025 through December 2025 for between $15 to $20.
Updated Apr 2About 3,540 units
The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring contai…
Hazard. The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring 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 take the recalled light-up rings away from children, stop using them immediately and remove and properly dispose of the batteries
Consumers will be asked to throw away the light-up rings and send a photo of the disposed product to [email protected] for a full refund
GLMZZ Fidget Magnet Ball Toys Recalled Due to Risk of Serious Injury or Death from Magnet…
Online at Amazon.com from February 2025 to October 2025 for about $15.
Updated Mar 26About 9,350 units
The magnet ball toys violate the mandatory standard for toys because they are high-powered magnets, posing an ingestion hazard to children.…
Hazard. The magnet ball toys violate the mandatory standard for toys because they are 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 contact GLMZZ to receive a full refund
Consumers will be asked to throw the magnet ball toys away and email photo of the disposal to [email protected]
FUNTOK Ride-On Trucks Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or…
Shenzhen Luobei Trading (China)
Updated Mar 26About 1,980 units
The truck's circuit board can overheat and ignite, posing fire and burn hazards.
Hazard. The truck's circuit board can overheat and ignite, posing fire and burn hazards.
What to do
Consumers should stop using the recalled ride-on truck immediately, unplug the truck if it is charging, and contact Shenzhen Luobei Trading Co. for instructions to receive a full refund
To obtain a refund, consumers will need to disable the ride-on truck by cutting the wires to the battery and sub…
CCCEI Brand Power Strips Recalled Due to Risk of Serious Injury or Death from Fire; Sold…
Online at Amazon.com from April 2024 to January 2026 for between $23 and $30.
Updated Mar 26About 5,543 units
The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The …
Hazard. The power strips do not contain supplementary overcurrent protection, which creates a risk of fire if the power strips are overloaded. The resulting fire can cause serious injury or death from smoke inhalation and burns.
What to do. Consumers should immediately stop using the CCCEI power strips and contact Middle Way Electronics to receive a full refund.
french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET…
French Broad Chocolate Factory
Updated Apr 2334/2.5oz boxes, 400/5oz boxes, … units
Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach …
Hazard. Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.
Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…
Cook
Updated Apr 211,253 units
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
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…
HALO Dream Recalls Magic Sleepsuits Due to Choking Hazard
HALO Dream, of New York City
Updated Mar 5About 45,000 units
The zipper head can detach from certain sleepsuits, posing a choking hazard to infants.
Hazard. The zipper head can detach from certain sleepsuits, posing a choking hazard to infants.
What to do
Consumers should stop using the recalled HALO Magic Sleepsuit immediately and go to the firm's website at http://www.sleepsuitrecall.com to participate in the recall
After registering, consumers will receive a coupon code that can be applied towards a replacement sleepsuit or a $50 store credit to…
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
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…
Specialized Bicycle Components Recalls Specialized Turbo Como SL Electric Bicycles Due to…
Specialized Bicycle Components, of Morgan Hill, California
Updated Mar 19About 5,720 units
The bike's fork steerer tube can develop a small fatigue crack that can lead to a progressive failure of the fork, posing a fall hazard.
Hazard. The bike's fork steerer tube can develop a small fatigue crack that can lead to a progressive failure of the fork, posing a fall hazard.
What to do
Consumers should stop using their Specialized Turbo Como SL bicycles immediately and contact their Authorized Specialized Retailer to schedule an appointment to bring their bike in for a free replacement of the fork at an authorized dealer location
Replacement parts are expected to be available in…
ProRider Recalls Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury…
ProRider, of Kent, Washington
Updated Mar 12About 9,546 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, 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 immediately stop using the recalled helmets and contact ProRider for a full refund
Consumers should destroy the helmet by cutting the straps and sending a photo of the destroyed helmet to [email protected] to obtain a refund
17 Stories Furniture 14-Drawer Dressers Recalled Due to Risk of Serious Injury or Death…
Hong Kong Baojia International (China)
Updated Mar 12About 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 standard 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
Contact Hong Kong Baojia International for instructions on how to identify affected units and dispose of the dressers to receive a full refund
Cubimana Island Storm 3 In 1 Building Sets Recalled Due to Risk of Serious Injury or…
Online at Amazon.com from October 2025 through January 2026 for about $30.
Updated Mar 5About 3,950 units
The Island Storm Building Sets violate the mandatory safety standard for toys because the battery compartment within the LED light piece co…
Hazard. The Island Storm Building Sets violate the mandatory safety standard for toys because the battery compartment within the LED light piece 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 take the Island Storm 3 In 1 Building Sets away from children immediately, stop using the recalled toys and remove and properly dispose of the batteries
Consumers will be asked to throw the product away and send a photo of the disposed product to [email protected] to …
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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…
Residential Elevators Recalls Elevator StrikeLock Hoistway Door Locking Device Due to…
Residential Elevators and authorized elevator dealers nationwide from April 2024 through March 2026 for about $1,000.
Updated Apr 30About 450 units
The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of seriou…
Hazard. The elevator's StrikeLock hoistway door locking device can allow the elevator cab to move with a landing door open, posing a risk of serious injury or death due to fall and injury hazards.
What to do. Consumers should immediately stop using the residential elevator systems where StrikeLock hoistway door locking devices are installed and contact Residential Elevators or the local elevator dealer that installed their residential elevator system to schedule a free repair of their StrikeLock hoistwa…
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
Online at Amazon.com from October 2025 through January 2026 for about $90.
Updated Apr 3050 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should immediately stop using the recalled pressure washers and contact DGIVOVO US for a free replacement pressure washer of at least equal value to the recalled pressure washer, including shipping
Consumers will be asked to destroy the pressure washer by unplugging it and cutting the po…
Earthtec Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from…
Tonyidea
Updated Apr 30About 211 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 stop using pools with the recalled pool drain covers immediately
To receive a refund, consumers should remove the drain cover from the pool, and destroy it, take a photo of the removed cover, and send it to Tonyidea by email at earthtecrecall@outloo…
Magnetic Stick Figure Sets Recalled Due to Risk of Serious Injury or Death from Magnet…
BlissfulDestiny (China)
Updated Apr 23About 140 units
The magnetic stick figures violate the mandatory standard for toys because they contain loose magnets posing an ingestion hazard to childre…
Hazard. The magnetic stick figures violate the mandatory standard for toys because they contain 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 death.
What to do
Consumers should stop using the recalled magnetic stick figures immediately and take them away from children
Contact BlissfulDestiny for information on how to receive a full refund
Consumers will be asked to throw the recalled magnetic stick figures away and email a photo of the disposed product …
HappyGira Recalls Sweetie Baby and Style Life Eleven Baby Loungers Due to Risk of Serious…
Online at HappyGira.com from September 2025 through February 2026 for between $70 and $100.
Updated Apr 23About 70 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 and they do not have a stand, posing a fall hazard. Additionally, an infant can fall out of the enclosed opening at the foot of the lounger or become entrapped. Furthermore, the sleeping pad's thickness exceeds the maximum limit, posing a…
What to do
Consumers should stop using the baby loungers immediately and contact HappyGira for a full refund
Consumers will be asked to destroy the loungers by removing the sleeping pad and bumpers covers, cutting the bumpers, sleeping pad and the covers in half, and send a photo of the destroyed pieces to?s…
Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment…
AMZCMJ DGD (China)
Updated Apr 23About 130 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 tower's sides, posi…
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 tower's 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 contact AMZCMJ DGD for a full refund
Consumers will be asked to destroy the stool by writing "recalled" in permanent marker on all sides, disassembling it and sending a photo of the destroyed stool to dgdtoddlertowerrecall@dchsk…
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
BAYOTAK USA (China)
Updated Apr 16360 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should immediately stop using the recalled pressure washers and contact BATOYAK USA for a free replacement pressure washer of at least equal value to the recalled pressure washer, including shipping
Consumers will be asked to destroy the pressure washer by unplugging it and cutting the p…
nvyue Magic Pocket Staffs Recalled Due to Projectile and Laceration Hazards; Imported by…
Xingwenfeng (China)
Updated Apr 16About 25,000 units
The protective pin mechanism on the Magic Pocket Staffs can fail to prevent unintentional expansion, posing serious projectile and lacerati…
Hazard. The protective pin mechanism on the Magic Pocket Staffs can fail to prevent unintentional expansion, posing serious projectile and laceration hazards. Even when engaged, the expansion occurs too rapidly for consumers to react, leaving virtually no opportunity for protection.
What to do
Consumers should stop using the Magic Pocket Staff immediately and contact Xingwenfeng for a full refund
Consumers will be asked to write their initials and the current date with permanent marker on the Magic Pocket Staff and send a photo of the marked Magic Pocket Staff to [email protected]…
Fun and Function Recalls Children's Metal Multi-Point Swing Frames Due to Risk of Injury…
Fun and Function, of Narberth, Pennsylvania
Updated Apr 16About 1,300 units
The swing frames can crack or break during use, posing a fall hazard, which can result in injury.
Hazard. The swing frames can crack or break during use, posing a fall hazard, which can result in injury.
What to do
Consumers should immediately stop using the recalled multi-point suspension swing frame and contact Fun and Function for a full refund
Consumers should register at https://funandfunction.com/pages/swing-recall and disassemble and dispose of the product, according to the directions provided on the …
Fengrong Tool Recalls Pressure Washers Due to Serious Risk of Injury or Death from Shock…
Online at Amazon.com from October 2025 through January 2026 for between $80 and $130.
Updated Apr 16About 500 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Fengrong Tool for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord and send a photo of the destroyed power washer to [email protected]
ATOYUS Children's Activity Cubes Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from January 2026 through February 2026 for about $26.
Updated Apr 16About 70 units
The recalled toys violate the small parts ban because the toys are intended for children under three and the toys' xylophone screws and clo…
Hazard. The recalled toys violate the small parts ban because the toys are intended for children under three and the toys' xylophone screws and clock hands can detach. In addition, the toys violate the mandatory safety standard for children's toys because the mallets have spherical ends, posing a choking hazard.
What to do
Consumers should immediately stop using the recalled toys, take them away from children and contact Melofaver US for a full refund
Consumers will be asked to destroy the toy by writing "recalled" on all sides of the multi-sided wooden cube and cutting the playmat in half and email a photo of the d…
Agiiman Recalls Pressure Washers Due to Serious Risk of Injury or Death from Shock and…
Online at Amazon.com from October 2025 through November 2025 for about $90.
Updated Apr 1680 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI), posing a serious risk of injury or death from shock and electrocution.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Agiiman for a full refund
Consumers will be asked to cut the power cord in half to destroy the pressure washer and send a photo of the destroyed pressure washer to [email protected]
Yeeluzan Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from May 2025 through March 2026 for about $32.
Updated Apr 9About 640 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 full refund to their original payment method, consumers should destroy the removed drain cover, take a clear photograph/video of the destroyed product as proof of destruct…
Wybotics Recalls Robotic Pool Vacuums Due to Burn and Fire Hazards
Wybotics of Tianjin, Chin
Updated Apr 9About 5,000 units
The lithium-ion battery in the recalled pool vacuums can overheat, posing burn and fire hazards to consumers.
Hazard. The lithium-ion battery in the recalled pool vacuums can overheat, posing burn and fire hazards to consumers.
What to do
Consumers should stop using the recalled robotic pool vacuums immediately and contact Wybotics to receive a free replacement WYBOT C2 robotic pool vacuum
Wybotics will provide a free return label for consumers to send the recalled product back to Wybotics
ShymeryDirect LED Lights Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from January 2026 through March 2026 for about $23.
Updated Apr 9About 295 units
The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain …
Hazard. The recalled LED lights violate the mandatory standard for consumer products containing button cell or coin batteries because they contain lithium coin batteries that can be accessed easily by children, posing an ingestion hazard. Additionally, the LED lights do not have the warnings required by Reese's Law. If coin batteries are swallowed, they can cause serious injuries, internal chemical burns…
What to do
Consumers should immediately stop using the recalled LED lights and place them in an area where children cannot access them
Consumers will be asked to disassemble and submerge all components in water
To receive a full refund, email a photo showing the submerged product to Shymeryrecall0402@outloo…
Shenzhen Shijingjie Network Technology Male-to-Male Extension Cords Recalled Due to Risk…
Online at Walmart.com from April 2025 through November 2025 for between $18 and $26.
Updated Apr 9About 200 units
The recalled male-to-male extension cords violate safety requirements because their exposed prongs can become energized when one end is plu…
Hazard. The recalled male-to-male extension cords violate safety requirements because their exposed prongs can become energized when one end is plugged into a generator or other power source, posing a risk of serious injury and death from electrocution. In addition, using the cords to supply power from a generator to a residential electrical system (backfeeding) poses a risk of electrocution and fire. Th…
What to do. Consumers should stop using the recalled extension cords immediately, taking care not to touch the live end of the cord when unplugging, and contact Shenzhen Shijingjie Network Technology for a full refund.
Shenzhen Baihang Recalls VEEKTOMX Mini Power Banks, Due to Fire and Burn Hazards; Sold on…
Shenzhen Baihang Technology (China)
Updated Apr 9About 8,000 units
The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
Hazard. The lithium-ion battery in the recalled power banks can overheat and ignite, posing fire and burn hazards to consumers.
What to do. Consumers should immediately stop using the recalled power banks and contact Shenzhen Baihang to verify power bank is part of the recall and receive a free replacement power bank.
Seasonal Specialties Recalls Members Mark 7' Pre-Lit Twinkling Bucks Due to Burn Hazard
Seasonal Specialties, of Eden Prairie, Minnesota
Updated Apr 9About 2,460 units
If the wires are connected incorrectly, the current limiting resistor can overheat, posing a burn hazard.
Hazard. If the wires are connected incorrectly, the current limiting resistor can overheat, posing a burn hazard.
What to do
Consumers should stop using the Members Mark 7' Pre-Lit Twinkling Buck immediately and contact Seasonal Specialties to request either a full refund or a repair kit
The repair kit includes new instructions on how to connect the wires, color-coded wire labels and a cord tag warning sticker
Muscccm Pool Drain Covers Recalled Due to Risk of Serious Injury or Death from Entrapment…
Qingyuan Fenle Sauna & Pool Equipment (China)
Updated Apr 9About 480 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 should remove the drain cover from the pool, take a photo of the removed cover, and send it to SZ Hengxun by email at [email protected]
Halloween Pumpkin Carving Kits Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from March 2024 through December 2025 for between $9 and $20.
Updated Apr 9About 650 units
The recalled carving kits violate the mandatory standard for consumer products with button cell and coin batteries because the button cell …
Hazard. The recalled carving kits violate the mandatory standard for consumer products with button cell and coin batteries because the button cell batteries in the tea lights can be accessed easily by children, posing an ingestion hazard. Additionally, the product and its packaging do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batterie…
What to do
Consumers should stop using the recalled carving kits immediately and contact Besslly Store for a full refund
Consumers will be asked to email a photograph of disposal to [email protected] to receive the refund
TecFlox Hair and Beard Growth Serum Bottles Recalled Due to Risk of Serious Injury or…
Amazon.com in October 2025 for about $30
Updated Apr 2About 900 units
The hair and beard growth serum contains minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packag…
Hazard. The hair and beard growth serum contains minoxidil, 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 immediately secure the recalled serum bottles out of sight and reach of children and contact TecFlox to receive free replacement serum bottles, including shipping
Only bottles with serum remaining will be replaced
Consumers will be asked to dispose of the bottles' contents and em…
OCUN NA Recalls Condor HMS Triple Carabiners Due to Risk of Serious Injury or Death from…
OCUN NA, of Park City, Utah
Updated Apr 2About 295 (in addition, about n… units
The carabiner's gate can malfunction where the gate does not close automatically and has to be closed manually by hand, posing a risk of se…
Hazard. The carabiner's gate can malfunction where the gate does not close automatically and has to be closed manually by hand, posing a risk of serious injury or death due to falling.
What to do
Consumers should stop using the recalled carabiner immediately and contact OCUN NA for a free replacement
Consumers will be asked to fill out the recall form and email it to [email protected] and follow the instructions to receive a prepaid return shipping label and return the recalled product
Gavoyeat Halloween Light-Up Rings Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from June 2025 through January 2026 for about $15.
Updated Apr 2About 800 units units
The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring contai…
Hazard. The recalled light-up rings violate the mandatory safety standard for toys because the battery compartment within the LED light ring 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 take the recalled light-up rings from children, stop using the recalled toys immediately and remove and properly dispose of the batteries
Consumers will be asked to throw away the light-up rings and send a photo of the disposed product to [email protected]
ELENKER Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2023 through February 2026 for about $80.
Updated Apr 2About 30 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users …
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, 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 Fuzhou Shiahaha Cultural Industry Development for a full refund
Consumers will be asked to write "RECALL" with permanent marker on the bed rails and then dispose of the recalled product in accordance with the state and loca…
Children's Toys Recalled Due to Risk of Serious Injury or Death from Choking Hazard…
Online at Amazon.com from November 2025 through December 2025 for about $15.
Updated Apr 2About 200 units
The recalled spiral tower toy sets violate the mandatory standard for toys because they contain small balls and are intended for children u…
Hazard. The recalled spiral tower toy sets violate the mandatory standard for toys 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 take the toys away from children immediately and contact Beestech for a full refund
Consumers will be asked to write "Recalled" with permanent marker on the toy and send a photo of the marked toy to [email protected]
MPINOI Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from…
Bioenrrty (China)
Updated Mar 26About 200 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. 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 Bioenrrty for a full refund
Consumers will be asked to destroy the bed rails by cutting the black safety strap in half and writing "RECALLED" on the upper and lower rails with permanent marker, take a photo o…
Lucerne 2% Cottage Cheese 2% Milkfat Small Curd Vitamin A Added Grade A. Net wt.24oz…
Albertsons Companies
Updated Mar 1612,222 tubs (24oz. per tub) units
Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.2…
Hazard. Metal fragments. The potential foreign object is a hard, metal (stainless steel), curled spring. Dimensions of a similar spring measure 2.27mm in cross-sectional thickness and 25.38mm in coil width. Spring ends are not sharp but may be sharp if broken/ cut.
Montebianco, 113542 Base Vegan, 2 Kg (4.41 Lb) Bag, packed 8 bags per master case of 2 Kg…
Disaronno Ingredients
Updated Mar 415 boxes (8 bags per case of 2K… units
Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being …
Hazard. Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *
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.
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyo…
Hazard. It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data.…
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001)…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 283314 units (816 US, 2498 OUS) units
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Integris-Allura system; System Code Description (Model Numbers): Integris CV…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 2825 units (11 US, 14 OUS) units
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potent…
Hazard. The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor …
Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the…
Bayer Medical Care
Updated Apr 2411,300 units (1650 US, 9650 OUS) units
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple cust…
Hazard. Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, le…
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to re…
Hazard. Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material…
Siemens Healthcare Diagnostics
Updated Apr 271725 (38025 US, 33700 OUS) units
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated …
Hazard. Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic …
Updated Apr 130775 units (25625 US, 5150 OUS) units
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
Updated Apr 1369650 units (150875 US, 218775… units
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF…
Erbe Medical
Updated Mar 31260,962 units
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
Gentuity
Updated Mar 23184 units (28 US, 156 OUS) units
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with th…
Hazard. The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters. This correction is intended to ensure that users are fully informed of how to recognize, avoid, and mitigate this condition to maintain accurate longitudinal (length) measurements during OCT imaging.
Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…
Cook
Updated Apr 24,245 units
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in…
MAGNESIUM SULFATE
Updated Mar 18784 (12x100mL) cartons units
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid…
Hazard. Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged…
Market of Choice
Updated May 4289 (9.5oz) units units
Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not dec…
Hazard. Undeclared allergen (sesame). Ingredients panel does not list sesame as sub-ingredient of Za'atar spice and Contains statement does not declare sesame.
Tainoki Fine Furniture Recalls Office Chairs Due to Risk of Serious Injury and Fall Hazard
Tainoki Fine Furniture, of Brea, California
Updated Mar 19About 2,200 units
The recalled chairs' base can bend, posing a fall hazard.
Hazard. The recalled chairs' base can bend, posing a fall hazard.
What to do
Consumers should stop using the recalled chairs immediately and visit https://www.tainoki.com/recall for instructions on how to participate in the recall
Consumers will be asked to submit photos of the recalled chairs, the model number and proof of destruction for a full refund
Infant Walkers Recalled Due to Risk of Serious Injury or Death from Fall Hazard; Violate…
Online at Amazon.com in January 2026 for about $90.
Updated Mar 19About 90 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 immediately stop using the recalled infant walkers and contact Goregent Official Store for a full refund
Consumers will be asked to disassemble the walker, remove the fabric seat, write "Recalled" on the top of the tray in permanent marker and send a photo of the recalled infant w…
Aisstxoer Adult Bicycle Helmets Recalled Due to Risk of Serious Injury or Death from Head…
Online at Amazon.com from October 2025 through November 2025 for about $25.
Updated Mar 19About 200 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, 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 adult helmets immediately and contact YXTDZ Store 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 to [email protected]
LIVEHOM 11-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over…
Online at Amazon.com from December 2025 through January 2026 for about $110.
Updated Mar 12About 370 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 immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access
Contact Simplehome for a full refund
Consumers will be asked to write "RECALL" with permanent marker on the dressers and send a photo of the mar…
Unique Brands Com Recalls Forever 21 Pajama Pants Due to Risk of Serious Injury or Death…
Online at Forever21.com from September 2025 through November 2025 for about $25.
Updated Mar 5About 230 units
The recalled children's pajama pants violate the mandatory standards for flammability of children's sleepwear, posing a burn hazard and ris…
Hazard. The recalled children's pajama pants violate the mandatory standards for flammability of children's sleepwear, posing a burn hazard and risk of serious injury or death to children.
What to do
Consumers should stop using the recalled pajama pants immediately and contact Unique Brands Com for a full refund
Consumers will be provided with a prepaid shipping label to return the recalled kids pajama pants
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…
Boston Scientific
Updated Mar 19685,776 units units
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchr…
Hazard. Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that requi…
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in…
Medline Industries, LP
Updated Mar 19486946 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
Medline Industries, LP
Updated Mar 19538201 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total)…
Medline Industries, LP
Updated Mar 191552486 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total)…
Medline Industries, LP
Updated Mar 19263739 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac…
Boston Scientific
Updated Mar 19718,456 units units
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchr…
Hazard. Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that requi…
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number…
B Braun Medical
Updated Mar 192,653,711 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number…
B Braun Medical
Updated Mar 191,174,271 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number…
B Braun Medical
Updated Mar 193,158,104 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number…
B Braun Medical
Updated Mar 19328,640 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slo…
Hazard. Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo unnecessary additional diagnostic testing. A patient may be treated for a disorder not present or receive delayed treatment for hyperthyroidism. For a pregnant pati…
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit…
Magellan Diagnostics
Updated Mar 13197893 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into …
Hazard. Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is…
ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600…
Siemens Medical Solutions USA
Updated Mar 10U.S. 758, OUS 2077 units
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the rep…
Hazard. During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.
The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6480,000 units
In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH…
Angiodynamics
Updated Mar 34925 units (985 boxes) units
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diam…
Hazard. The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
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…
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
Thermos Recalls 8.2 Million Stainless King Food Jars and Bottles Due to Serious Impact…
Thermos L.L.C., of Schaumburg, Illinois
Updated Apr 30About 5.8 million Stainless Kin… units
If perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefully eject when opened, w…
Hazard. If perishable food or beverages are stored in the container for an extended period of time, the stopper can forcefully eject when opened, which can result in serious impact injury and laceration hazards to the consumer.
What to do
Consumers should stop using the recalled Food Jars and Bottles immediately and contact Thermos to receive a free replacement pressure relief stopper or replacement Bottle, depending on the model
For recalled 3000 and 3020 Food Jars, consumers will be asked to throw away the stopper and send a phot…
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month…
Hazard. CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
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,…
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.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 2713,320 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose val…
Hazard. A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe i…
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP…
ARROW INTERNATIONAL
Updated Apr 1034,568 units
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be…
Hazard. Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Becton Dickinson &
Updated Apr 725,760 units units
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating…
Hazard. BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, …
Hazard. Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list …
Hazard. Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in …
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap…
Erbe Medical
Updated Mar 3123,359 units
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula…
Zimmer
Updated Mar 3066960 units
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles i…
Hazard. Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, p…
Hazard. Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an in…
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, c…
Hazard. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setu…
Hazard. Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak…
Advanced Bionics
Updated Mar 2345173 units
The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a to…
Hazard. The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.
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
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month …
Hazard. Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg…
OCTREOTIDE ACETATE
Updated Mar 1721,930 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg…
OCTREOTIDE ACETATE
Updated Mar 1719,869 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection pr…
Hazard. Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Nexgrill Recalls Over 10.2 Million Metal Wire Bristle Grill Brushes Due to Ingestion…
Nexgrill Industries of Chino, California
Updated Mar 26About 10.2 million 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 immediately stop using the recalled grill brushes and contact Nexgrill for a full refund to be issued as a gift card
Consumers will be provided with a registration code as part of the recall process and will be directed to upload a photograph of their grill brush with that code an…
Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)
Medline Industries, LP
Updated Mar 1922116 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 1910400 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 1921288 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics
Updated Mar 1818,080 units units
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potentia…
Hazard. Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA7005 on the Dimension System. This imprecision may lead to erroneously decreased or increased creatinine patient results
Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads…
Medline Industries, LP
Updated Mar 1628550 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep…
Medline Industries, LP
Updated Mar 1640845 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep…
Medline Industries, LP
Updated Mar 1617550 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single…
Stryker Sustainability Solutions
Updated Mar 1256,740 cuffs units
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintai…
Hazard. Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac…
Medtronic
Updated Mar 1177510 units units
ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Impl…
Hazard. ventricular fibrillation (VF) during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and C…
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In…
OCTREOTIDE ACETATE
Updated Apr 242,200 kits units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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.
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 285,537 units units
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical we…
Hazard. Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 273,550 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by ma…
Hazard. The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 273,130 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 275,940 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product…
GE Medical Systems Information Technologies
Updated Apr 241249 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in…
GE Medical Systems Information Technologies
Updated Apr 242187 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF…
GE Medical Systems Information Technologies
Updated Apr 242366 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
GE Medical Systems Information Technologies
Updated Apr 241835 units
Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparkin…
Hazard. Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush becomes dislodged, electrical sparking at the printer head can result in charring or discoloration of thermal printer paper. Ignition of the paper could potentially result in serious thermal injury.
Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow tra…
Hazard. Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm…
Novapproach Spine
Updated Apr 231259 units
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to secure…
Hazard. Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System…
Shimadzu Medical Systems
Updated Apr 203487 units units
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if pow…
Hazard. Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;
Covidien, LP
Updated Apr 152448 units units
The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from enviro…
Hazard. The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Becton Dickinson &
Updated Apr 72,200 units units
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating…
Hazard. BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen …
Hazard. Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may b…
Hazard. Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, c…
Hazard. Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to…
Hazard. Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco…
Hologic
Updated Mar 231200 units units
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modifica…
Hazard. It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducte…
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.
Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum c…
Hazard. Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg…
OCTREOTIDE ACETATE
Updated Mar 171,897 Cartons units
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection a…
Hazard. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a rece…
Hazard. Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France…
IVIZIA DRY EYE
Updated Apr 23
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufact…
Hazard. Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufact…
Hazard. Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct …
Hazard. Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating…
American Contract Systems
Updated Mar 197,311 kits units
Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose …
Hazard. Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 193290 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 197004 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 193000 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 192228 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 193170 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 192153 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 193588 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 191294 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 199805 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 194016 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 194324 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 191824 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,848 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number…
B Braun Medical
Updated Mar 194,884 units units
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative press…
Hazard. Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Mar 191,033 units units
Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determine…
Hazard. Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY…
Medical Action Industries 306
Updated Mar 172030 kits units
Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconn…
Hazard. Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold"
Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as…
Medline Industries, LP
Updated Mar 164050 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 161590 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
AVID Medical
Updated Mar 136,052 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
AVID Medical
Updated Mar 132,392 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
AVID Medical
Updated Mar 132,932 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM r…
Hazard. insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users incl…
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for…
Brahms
Updated Mar 125,254 units
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which requi…
Hazard. Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ra…
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.
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.
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.
Pediatric care bed; Product Designation: KayserBett IDA;
KAYSERBETTEN & KG
Updated May 4372 units units
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child)…
Hazard. If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even de…
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Updated Apr 30
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyo…
Hazard. It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data.…
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 270 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27990 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL…
Becton Dickinson &
Updated Apr 27150 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in…
Becton Dickinson &
Updated Apr 27290 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27890 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…
Becton Dickinson &
Updated Apr 27330 units units
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The…
Hazard. This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code…
GE Medical Systems Information Technologies
Updated Apr 24476 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by…
GE Medical Systems Information Technologies
Updated Apr 2414 units units
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemet…
Hazard. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U…
Bolton Medical
Updated Apr 22
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from …
Hazard. Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System…
GE Medical Systems China
Updated Apr 2116 units
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information bein…
Hazard. Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.
A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These …
Hazard. A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on t…
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 146 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number…
Philips North America
Updated Apr 1414 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2…
Philips North America
Updated Apr 1486 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.
Philips North America
Updated Apr 1415 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2…
Philips North America
Updated Apr 146 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116…
Philips North America
Updated Apr 148 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model…
Philips North America
Updated Apr 1425 untis units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model…
Philips North America
Updated Apr 1454 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2…
Philips North America
Updated Apr 1422 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2…
Philips North America
Updated Apr 14103 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.
Philips North America
Updated Apr 141 unit units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2…
Philips North America
Updated Apr 147 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model…
Philips North America
Updated Apr 1464 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF)…
Philips North America
Updated Apr 143 units units
The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's …
Hazard. The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code…
Jolife AB
Updated Apr 13153 systems units
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The docu…
Hazard. Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection…
Hazard. Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P
Medline Industries, LP
Updated Apr 108 kits units
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled thes…
Hazard. Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to…
Hazard. Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath i…
Hazard. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Becton, Dickinson and
Updated Apr 8183 units
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead…
Hazard. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking…
MICROVENTION
Updated Apr 638 units
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configura…
Hazard. Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…
Windstone Medical Packaging
Updated Apr 2150 kits (US only) units
Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding…
Hazard. Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica
Updated Apr 1359 units units
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorre…
Hazard. Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON…
Boston Scientific
Updated Mar 30148 units units
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (bot…
Hazard. For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these feature…
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US…
Boston Scientific
Updated Mar 302 units units
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (bot…
Hazard. For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these feature…
AIDBAGs are first aid kits of convenience composed of individually labeled devices…
North American Rescue
Updated Mar 2721 units
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the softwar…
Hazard. Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment.…
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
GE Medical Systems
Updated Mar 2611 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE Medical Systems
Updated Mar 2624 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE Medical Systems
Updated Mar 2633 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE Medical Systems
Updated Mar 265 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
GE Medical Systems
Updated Mar 2625 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE Medical Systems
Updated Mar 2610 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE Medical Systems
Updated Mar 2638 units units
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Sma…
Hazard. GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems
Updated Mar 2542 units
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pres…
Hazard. Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within…
Foundation Medicine
Updated Mar 2410 units units
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT soft…
Hazard. Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic…
DISCOUNT DRUG MART
Updated Mar 20N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey…
DISCOUNT DRUG MART
Updated Mar 20N/A units
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of …
Hazard. This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection pr…
Hazard. Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
Centinel Spine
Updated Mar 2030 units units
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Lar…
Hazard. Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc…
Centinel Spine
Updated Mar 2030 units units
Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Lar…
Hazard. Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH…
Medline Industries, LP
Updated Mar 19152 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19380 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 19208 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 19413 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19306 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19340 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19120 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 19632 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1…
Medline Industries, LP
Updated Mar 19924 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19160 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows…
Medline Industries, LP
Updated Mar 19104 kits units
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indic…
Hazard. During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation …
Hazard. The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 16432 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled…
Medline Industries, LP
Updated Mar 16120 kits units
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol …
Hazard. Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.
AVID Medical
Updated Mar 13180 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.
AVID Medical
Updated Mar 13204 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.
AVID Medical
Updated Mar 13222 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.
AVID Medical
Updated Mar 1375 kits units
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection …
Hazard. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is…
Magellan Diagnostics
Updated Mar 13284 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is…
Magellan Diagnostics
Updated Mar 13136 units
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary sam…
Hazard. Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variati…
Hazard. During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Windstone Medical Packaging
Updated Mar 11475 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Windstone Medical Packaging
Updated Mar 11520 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Windstone Medical Packaging
Updated Mar 11380 units units
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration …
Hazard. The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connecti…
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Updated Mar 10119 units units
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in t…
Hazard. An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
Updated Mar 9
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been ob…
Hazard. During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono…
Siemens Medical Solutions USA
Updated Mar 9
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been ob…
Hazard. During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
Philips Spectral CT on Rails. Model Number: 728334.
PHILIPS MEDICAL SYSTEMS
Updated Mar 73 systems units
Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at …
Hazard. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? or should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area …
The product is a handheld ultraviolet-C germicidal wand and contains a combination of…
Uvlizer c/o RAIS INTERNATIONAL
Updated Mar 6334 units
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommende…
Hazard. In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No…
Tornier
Updated Mar 5233 units
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and ar…
Hazard. Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
