Little Giant Recalls Ladders with Rapid Locks Due to Risk of Serious Injury from Fall…
Little Giant Ladder Systems, of Springville, Utah
Updated 4 days agoAbout 3,662,000 units
The ladders can suddenly retract if the Rapid Locks are not fully engaged, posing a fall hazard to consumers.
Hazard. The ladders can suddenly retract if the Rapid Locks are not fully engaged, posing a fall hazard to consumers.
What to do
Consumers should stop using the recalled ladders immediately until they review the information at www.littlegiantladders.com/pages/recalls or via the QR code on the ladder and contact Little Giant for a repair kit containing warning labels and instructions
Baby Brezza Enterprises Recalls SuperFast Sterilizer Dryers Due to Overheating and Burn…
Baby Brezza Enterprises, of Newark, New Jersey
Updated 4 days agoAbout 29,000 (In addition, abou… units
The recalled sterilizer dryers can overheat when plugged in and operating, posing a risk of injury from a burn hazard if the surface is han…
Hazard. The recalled sterilizer dryers can overheat when plugged in and operating, posing a risk of injury from a burn hazard if the surface is handled.
What to do
Consumers should stop using the recalled sterilizer dryers immediately and contact Baby Brezza Enterprises for a free replacement sterilizer dryer, including shipping at no cost to the consumer
Consumers will be asked to register at https://babybrezza.com/pages/about?view=v3-recalls, complete the …
Kikea Store Recalls X-VESOLJE Nursing Pillows Due to Risk of Serious Injury or Death from…
Sold Online At: Amazon.com from April 2025 through June 2026 for between $24 and $34.
Updated 4 days agoAbout 19,596 units
The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, po…
Hazard. The recalled nursing pillows violate the mandatory safety standards for nursing pillows 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 Kikea Store for a full refund
Consumers will be asked to cut the pillow in half after confirming the recalled pillow with the firm and send a photo of the destroyed pillow to [email protected]
Arlopu Recalls Slide Playsets Due to Risk of Serious Injury and Death from Head and Neck…
Arlopu (China)
Updated 4 days agoAbout 10,318 units
The recalled products contain multiple openings where a child’s torso can fit through the opening, but a child’s head cannot, posing a risk…
Hazard. The recalled products contain multiple openings where a child’s torso can fit through the opening, but a child’s head cannot, posing a risk of serious injury and death due to head and neck entrapment hazards. Additionally, the basketball nets on the recalled products with model number KT-CS17 can come unhooked from the rim, forming a loop large enough for a child’s head, posing entangleme…
What to do
Consumers should stop using the Arlopu Slide Playsets immediately and store them away from children
Contact Arlopu for a free repair kit, which includes redesigned panels, basketball hoops and installation instructions
Consumers will be asked to provide a photo of the product showing the model nu…
Bose Recalls Lithium-Ion Battery Packs for S1 Pro and S1 Pro+ Bluetooth Speaker Systems…
Bo, of Framingham, Massachusetts
Updated 4 days agoAbout 634,759 (In addition, abo… units
The recalled lithium-ion battery packs can overheat and ignite, posing a risk of injury from fire and overheating hazards.
Hazard. The recalled lithium-ion battery packs can overheat and ignite, posing a risk of injury from fire and overheating hazards.
What to do
Consumers should remove the recalled battery packs installed in any S1 Pro and S1 Pro+ Portable Bluetooth Speaker Systems and stop using the battery packs immediately
Once the battery pack is removed, consumers may continue to use their S1 Pro and S1 Pro+ Portable Bluetooth Speakers while connecte…
NTI and HTP Brand Gas Boilers Recalled Due to Risk of Serious Injury or Death from Fire…
Ariston Canada (Formerly NTI Boilers) (Canada)
Updated Oct 294,726 (In addition, 2,261 were … units
The condensate dish inside the boiler can crack during a delayed ignition, allowing unburned gas to build up inside the sealed cabinet. If …
Hazard. The condensate dish inside the boiler can crack during a delayed ignition, allowing unburned gas to build up inside the sealed cabinet. If the gas ignites, the front cover can suddenly detach, posing a risk of serious injury or death from fire, carbon monoxide (CO) poisoning, and impact hazards.
What to do
Consumers should stop using the recalled boilers immediately and contact Ariston to schedule a free repair by a certified technician
Consumers who must continue using the boiler while awaiting repair should have working smoke and carbon monoxide alarms in their homes
Sanven Technology Recalls Vevor BMX Bicycles Due to Risk of Serious Injury or Death from…
Sanven Technology, Rancho Cucamonga, California.
Updated 4 days agoAbout 1,950 units
The bicycles violate the mandatory safety regulation for bicycles, because they are not equipped with a chain guard. Loose clothing can get…
Hazard. The bicycles violate the mandatory safety regulation for bicycles, because they are not equipped with a chain guard. Loose clothing can get entrapped in the chain drive, posing a risk of serious injury or deadly crash hazard. In addition, the bicycles do not comply with the labeling requirements.
What to do
Consumers should stop using the BMX bicycles immediately and contact Sanven Technology for a free repair kit
Consumers will be shipped free chain guards, with detailed installation tutorials and provided with after-sales support (such as customer service email) to help solve any issues arising dur…
Magnetopia Recalls Magnetic Building Cubes and Blocks Due to Risk of Serious Injury or…
Magnetopia (Hong Kong)
Updated 4 days agoAbout 7,600 units
The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to …
Hazard. The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and…
What to do
Consumers should stop using the recalled magnetic building cubes immediately and contact Magnetopia for a full refund
Consumers will be provided with a pre-paid label to return the recalled magnetic cubes to receive a refund
Jiastfeng Recalls HAUOMS Eight-drawer Dressers Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com from May 2025 through September 2026 for about $150.
Updated 4 days agoAbout 1,392 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Jiastfeng for a full refund
Consumers will be asked to write in permanent marker “RECALLED” on the top, front and sides of the dress…
C.A.M.P. Recalls Mountain Ice Axes Due to Risk of Serious Injury or Death from Fall Hazard
C.A.M.P. USA, of Golden, Colorado
Updated 4 days agoAbout 2,230 units
A screw on the recalled mountain ice axes can loosen during use, causing the handle or pick to detach, posing a risk of serious injury or d…
Hazard. A screw on the recalled mountain ice axes can loosen during use, causing the handle or pick to detach, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using the recalled mountain ice axes immediately and register at https://www.camp-usa.com/x-bolt-recall-102026 to receive a free repair kit
Consumers should have the model and batch number available, which can be found on the side of the axes’ shaft
DREO Recalls DR-HSH015 Space Heaters Due to Fire and Burn Hazards
DREO
Updated Oct 29About 338,800 (In addition, abo… units
The recalled space heaters can overheat and ignite, posing fire and burn hazards.
Hazard. The recalled space heaters can overheat and ignite, posing fire and burn hazards.
What to do
Consumers should stop using the recalled space heaters immediately and contact DREO for a free replacement space heater
Consumers will be asked to unplug the space heater, destroy it by cutting the electrical cord and follow instructions to send a photo of the destroyed heater
U.S. Titan Recalls X-Pro Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury…
U.S. Titan
Updated 4 days agoAbout 117 units
The recalled ATVs violate the mandatory ATV safety standard because the speed-adjusting module included with the vehicle allows for the ATV…
Hazard. The recalled ATVs violate the mandatory ATV safety standard because the speed-adjusting module included with the vehicle allows for the ATV’s speed to be adjusted in excess of the maximum speed for vehicles intended for children 6 years old and older, posing a risk of serious injury or death from a crash.
What to do
Consumers should stop using the speed-adjusting module included with the vehicle immediately and contact X-PRO for a $100 refund
Consumers can continue using the vehicle without the module
Consumers will be asked to return the module using a prepaid shipping label
Yinklev Recalls Jocoevol 6-Drawer Dressers Due to Risk of Serious Injury or Death from…
Sold Online At: Amazon.com from December 2024 through July 2026 for about $160.
Updated Oct 29About 32,791 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Yinklev for a full refund
Consumers will be asked to write in permanent marker “RECALLED” on the dresser and send a photo of the mar…
RootStim Recalls Minoxidil Hair Regrowth Treatment Bottles Due to Risk of Serious Injury…
Sold Online At: Amazon.com from August 2025 through February 2026 for between $20 and $40.
Updated Oct 29About 11,000 units
The recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Pac…
Hazard. The recalled hair regrowth products contain minoxidil, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The bottle is not child-resistant, posing a risk of serious injury or death from poisoning if the contents are ingested by young children.
What to do
Consumers should secure the recalled products out of sight and reach of children immediately and contact RootStim for instructions on receiving a replacement product
Consumers will be asked to write “RECALLED” on the bottle, discard the bottle and send a photo of the discarded bottle to finerg…
PILLANI Recalls Nursing Pillows Due to Risk of Serious Injury or Death from Suffocation…
Sold Online At: Amazon.com from April 2026 through September 2026 for between $30 and $40.
Updated Oct 29About 25,762 units
The recalled nursing pillows violate the mandatory safety standards for nursing pillows because they can obstruct an infant’s breathing, po…
Hazard. The recalled nursing pillows violate the mandatory safety standards for nursing pillows 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 nursing pillows immediately and contact PILLANI for a full refund
Consumers will be asked to send a photo of the product and be provided with disposal instructions
Consumers should then dispose of the recalled product
HatsanUSA Recalls Blitz Air Rifles Due to Risk of Serious Injury or Death from Projectile…
HatsanUSA, of Bentonville, Arkansas
Updated Oct 15About 16,170 units
The recalled air rifles can fire unexpectedly when releasing the bolt before the air rifle is fully cocked, posing a risk of serious injury…
Hazard. The recalled air rifles can fire unexpectedly when releasing the bolt before the air rifle is fully cocked, posing a risk of serious injury or death from projectile hazard.
What to do
Consumers should stop using the recalled air rifles immediately, make sure they are unloaded and contact HatsanUSA for a free trigger assembly replacement which will be mailed along with instructions
If the consumer does not want to complete the replacement of the air rifle trigger assembly on the…
3M Company Recalls Scotch™ Thermal Laminators Due to Risk of Serious Injury or Death from…
3M, of St. Paul, Minnesota
Updated Oct 15About 53,634 units
The recalled thermal laminators can overheat, posing a fire hazard.
Hazard. The recalled thermal laminators can overheat, posing a fire hazard.
What to do
Consumers should stop using and unplug the recalled thermal laminators immediately and contact 3M Company to receive a full refund
Consumers will be asked to fill out the online recall registration form at https://www.scotchbrand.com/3M/en_US/scotch-brand/tl1302Z-laminator-recall/, confirm that th…
Giant Bicycle Recalls LED-Light Keys Included with SureLock Bike Lock Sets Due to Risk of…
Giant Bicycle, of Newbury Park, California
Updated Oct 8About 3,630 (In addition, 1,395… units
The LED-light key that was included with certain SureLock Bicycle Lock sets violates the mandatory safety standard for consumer products wi…
Hazard. The LED-light key that was included with certain SureLock Bicycle Lock sets violates the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries ar…
What to do
Consumers should stop using the recalled LED-light key that was included with certain SureLock Bicycle Lock sets immediately and contact Giant Bicycle for a $5 refund
Consumers will be asked to bring the LED key to an authorized Giant retailer to participate in the recall and receive the refund
DR Power Equipment Recalls Pilot and Premier Trimmer Mowers Due to Risk of Serious Injury…
Generac Power Systems, of Waukesha, Wisconsin
Updated Oct 8About 42,860 (In addition, abou… units
Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards.
Hazard. Grass and debris can accumulate in the trimmer mowers and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled trimmer mowers immediately and contact DR Power Equipment for a free repair kit
If consumers have concerns about installing the repair kit, contact DR Power Equipment to schedule a free repair installation from an authorized dealer
Agrish Reannounces and Expands Recall of Adult Portable Bed Rails Due to Risk of Serious…
Zhongshan Lebo Medical (China)
Updated Oct 1About 35,083 units (About 5,000… 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. The bed rails do not meet structural stability or retention strap requirements, posing a fall h…
What to do
Consumers should immediately stop using the recalled adult portable bed rails and contact Agrish Direct for a full refund
Consumers will be asked to go to http://www.agrish.online/recall to register for the recall and receive instructions on how to dispose of the recalled bed rail
Sauna360 Recalls Infrared Saunas, Hybrid Infrared Saunas and Infrared Kits Due to Risk of…
Sauna360, of Cokato, Minnesota
Updated Sep 17About 41,580 (In addition, abou… units
The infrared panels in the saunas and kits can short circuit, causing them to overheat, posing a risk of serious injury from fire and burn …
Hazard. The infrared panels in the saunas and kits can short circuit, causing them to overheat, posing a risk of serious injury from fire and burn hazards.
What to do. Consumers should stop using the infrared and hybrid saunas immediately and contact Sauna360 to schedule a free in-home repair from a professional installer.
Esjay US Recalls Toddler Busy Board Montessori Toys Due to Risk of Serious Injury or…
Esjay US (China)
Updated Sep 17About 276,000 units
The recalled toy violates the small parts ban because the product is for children under three years of age and the red knobs can detach, po…
Hazard. The recalled toy violates the small parts ban because the product is for children under three years of age and the red knobs can detach, posing a deadly choking hazard.
What to do
Consumers should take the recalled toy away from children, stop using it immediately and contact Esjay for instructions on the repair
Consumers will be asked to unzip the page with red knobs, write “RECALLED” on both sides of the page and throw it away
ZMC Group Expands Recall of Light-Up Children’s Toys Due to Risk of Serious Injury or…
ZMC Group, of Los Angeles, California
Updated Sep 10About 245,124 (ZMC Group previo… units
The recalled light-up toys violate the mandatory safety standard for children’s toys because the toys contain button cell batteries that ca…
Hazard. The recalled light-up toys violate the mandatory safety standard for children’s toys because the toys contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the toys immediately, take them away from children and contact ZMC Group for a full refund
Consumers will be asked to remove the batteries, write “RECALLED” or a large “X” on the product with a permanent marker and submit a photo of the disposed product to recal…
Triumph Motorcycles Recalls Closed Course Competition Motorcycles Due to Risk of Serious…
Triumph Motorcycles America, of Atlanta, Georgia
Updated Sep 10About 1,560 (In addition, about… units
The engine rocker arm on the recalled motorcycles can seize or stick and the exhaust valves can remain open or break, posing a risk of seri…
Hazard. The engine rocker arm on the recalled motorcycles can seize or stick and the exhaust valves can remain open or break, posing a risk of serious injury or death from a crash hazard.
What to do
Consumers should stop using 2025 and 2026 Triumph TF450 models Closed Course Competition Motorcycles immediately and contact Triumph Motorcycles for a free repair
Consumers can check if their VIN is included in this recall at https://www.triumphmotorcycles.com/owners/recalls
Dual Fuel Ranges Recalled Due to Risk of Serious Injury or Death from Fire or Explosion…
AGA Rangemaster (United Kingdom)
Updated Sep 10About 3,992 (In addition, about… units
Dual Fuel Ranges with a missing cap from the gas test port can cause a gas leak, posing a risk of serious injury or death from fire or exp…
Hazard. Dual Fuel Ranges with a missing cap from the gas test port can cause a gas leak, posing a risk of serious injury or death from fire or explosion hazards.
What to do
Consumers should shut off the gas supply to avoid the risk of gas leak immediately and contact AGA Rangemaster
Consumers should promptly determine if their range is subject to recall by locating the model/serial number on the rating plate (on the bottom panel under the storage drawer) and visiti…
Cade California Electronic Recalls Finger Light Toys Due to Risk of Serious Injury or…
Sold At: Amazon.com from March 2015 through July 2026 for between $5 and $16.
Updated Sep 10About 179,739 units
The recalled finger lights violate the mandatory safety standard for toys because the toys contain button cell batteries that can be easily…
Hazard. The recalled finger lights violate the mandatory safety standard for toys because the toys contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact Cade California Electronic for a full refund
Consumers will be asked to properly dispose of the finger lights into the trash and send a photo of the disposed product to [email protected]. …
Skip Hop Recalls Baby Sesame Street Elmo Silicone Teethers Due to Risk of Serious Injury…
The William Carter, of Atlanta, Georgia
Updated Sep 3About 22,660 (In addition, abou… units
The black eyes can detach from the recalled teether if frozen, posing a risk of serious injury or death from a choking hazard.
Hazard. The black eyes can detach from the recalled teether if frozen, posing a risk of serious injury or death from a choking hazard.
What to do
Consumers should stop using the recalled teether immediately, take it away from children and contact Skip Hop Inc. at www.skiphoprecall.com to obtain a refund in the form of a gift card and further instructions on disposal of the product
The gift card can be used at any The William Carter Company …
Walmart Reannounces Recall of Mainstays Nine-Drawer Fabric Dressers Due to Risk of…
Hop Thang Interior Wood (Vietnam)
Updated Aug 27About 165,250 (About 165,000 of… units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of …
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risk of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers if they are not anchored to the wall immediately, place them in an area that children cannot access and contact Walmart for a full refund
Consumers will be asked to return the dressers’ drawers to any Walmart store and dispose of the dressers’ …
Workbless Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and…
Amazon.com, BestBuy, Kohls, Lowe's, Overstock, Target and Walmart from April 2025 through July 2026 for between $97 and…
Updated Aug 20About 2,200 (In addition, about… units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious ri…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Workbless for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to [email protected]
KTM North America Recalls Off-Road Motorcycles Due to Risk of Serious Injury or Death…
KTM North America, of Amherst, Ohio
Updated Aug 20About 21,040 (In addition, abou… units
The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash…
Hazard. The rear brake caliper can crack or break, reducing the brake system's effectiveness, posing a risk of serious injury or death due to crash hazard.
What to do. Consumers should stop riding the recalled motorcycles immediately and contact an authorized GASGAS or Husqvarna Motorcycle dealer to schedule a free repair at the dealership.
Yamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death…
Yongkang Dingchang Industry and Trade (China)
Updated Aug 13About 1,050 (Yamazuki vehicles … units
The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting…
Hazard. The recalled youth ATVs violate the mandatory safety standard for ATVs because the parking brakes fail to hold and the ATV's speed limiting device is not set to the restricted speed required for children ages six (6) and older, posing a crash hazard. Additionally, the ATVs are missing the required rear safety reflectors, reducing visibility of the youth ATV to other vehicles, posing a deadly cras…
What to do
Consumers should stop using the recalled youth ATVs immediately and contact Yamazuki for a free repair kit, including shipping
The repair kit consists of replacement parking brake latches, rear safety reflectors, an owner's manual storage bag and repair tools
Taleco Gear Recalls Baby Jumpers, Baby Swings and 2-in-1 Baby Jumper & Swings Due to Risk…
Tale Gear, of La Verne, California
Updated Aug 13About 41,100 (In addition, 150 … units
The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging r…
Hazard. The baby jumper, baby swing and 2-in-1 baby jumper & swing can become unstable, posing fall and impact hazards. Additionally, the hanging restraint straps and seat openings can pose strangulation hazards.
What to do
Consumers should stop using the recalled products immediately and contact Taleco Gear to receive a full refund
Consumers will be provided with instructions on how to destroy the recalled products and provide photos of the destroyed parts to obtain a full refund
Goody King Magnetic Building Cubes and Blocks Recalled Due to Risk of Serious Injury or…
Yi Suen Commerce (Hong Kong)
Updated Aug 13About 213,500 units
The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to …
Hazard. The recalled magnetic building cubes contain magnets that can become loose if the cubes break or open, posing a magnet ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects, and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and…
What to do
Consumers should stop using the recalled magnetic building cubes immediately and contact Yi Suen Commerce for a full refund
Consumers will be provided with a pre-paid label to return the recalled magnetic cubes to receive a refund
Winston Porter and Seeday 3-Drawer, 4-Drawer, and 5-Drawer Dressers Recalled Due to Risk…
The 3-Drawer Dresser was sold on Amazon.com from February 2026 through June 2026 for about $110. The 4-Drawer Dresser w…
Updated Aug 6About 2,000 5-Drawer Dressers, … units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Consumers should contact Linyi Lingmoxuan and Seeday for instructions on how to identify affected units and dispose of the dressers to receive a …
Recall of Cpzzkq Baby Loungers Expanded Due to Risk Serious Injury or Death from…
Online at Amazon.com from May 2026 through June 2026 for between $30 to $50.
Updated Jul 30About 2,195 (CetoPMax previousl… units
The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's b…
Hazard. The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a serious risk of injury or deadly suffocation hazard.
What to do
Consumers should stop using the baby loungers immediately and contact CetoPMax for a refund
Consumers will be asked to remove the foam and pad from the baby lounger's cover and cut the cover, foam and pad in half
Consumers should then email photos of the destroyed pieces to CetoPMaxRecall@outlook…
Heated Sherpa Throws and Blankets Recalled Due to Risk of Serious Injury or Death from…
Online at Amazon.com from August 2021 through December 2025 for between $40 and $60.
Updated Jul 30About 178,000 units
The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and…
Hazard. The electrical cord on the recalled throws and blankets can detach and ignite, posing a risk of serious injury or death from fire, burn and shock hazards.
What to do
Consumers should stop using the recalled throws and blankets immediately and contact OCTROT for a full refund
Consumers will be asked to destroy the throws and blankets by unplugging the electrical cord and cutting it in half, and to send a photo of the destroyed product, showing the cut electrica…
Galanz Americas Recalls Retro Refrigerators Due to Risk of Serious Injury or Death from…
Zhongshan Galanz (China)
Updated Jul 30About 121,680 units
The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire…
Hazard. The recalled refrigerators' internal electrical components can short circuit and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do. Consumers should unplug and stop using the recalled refrigerators immediately until repaired and contact Galanz to schedule free in-home repair by a qualified technician.
BenQ America Recalls GV31 Portable Projectors Due to Risk of Serious Injury or Death from…
BenQ America, of Costa Mesa, California
Updated Jul 30About 1,249 (In addition, about… units
The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards.
Hazard. The recalled projectors' lithium-ion battery can overheat, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the projectors immediately and contact BenQ for a free battery repair or replacement projector, including shipping
Consumers will be asked to register at https://www.benq.com/en-us/support/gv31recall.html and receive a prepaid label and package to return the recalled pr…
Lithonia Lighting Recalls RSX Luminaires with Adjustable Tilt Arm Mountings Due to Risk…
Lithonia Lighting, of Atlanta, Georgia
Updated Oct 22About 11,532 units
The knuckle of the recalled adjustable tilt arm mountings can fail, allowing the luminaire to fall from the mounting arm, posing a risk of …
Hazard. The knuckle of the recalled adjustable tilt arm mountings can fail, allowing the luminaire to fall from the mounting arm, posing a risk of serious injury due to impact hazard.
What to do
Consumers should keep clear of the area directly beneath the Luminaire and contact Lithonia Lighting to schedule a free repair
Lithonia Lighting will arrange for a qualified professional to replace the recalled adjustable tilt arm mount with a new complete adjustable arm assembly
Pacearth Direct Recalls PACEARTH Swing Seats Due to Risk of Serious Injury from Fall…
Sold Online At: Amazon.com from May 2017 through June 2026 for between $27 and $57.
Updated Oct 8About 110,550 units
The seats, metal carabiners or quick links, or webbing straps of the recalled swing seats can break during use, posing a risk of serious in…
Hazard. The seats, metal carabiners or quick links, or webbing straps of the recalled swing seats can break during use, posing a risk of serious injury due to fall hazard.
What to do
Consumers should stop using the recalled swing seats immediately and contact Pacearth Direct for a full refund
Consumers will be asked to write "RECALLED" on the swing seat with permanent marker, take a photo of it, including the PACEARTH logo and email to [email protected]
Kobayashi Recalls Rechargeable Hand Warmers Due to Risk of Serious Injury from Fire and…
Sold At: Bass Pro Shops, Meijer, Target and The Home Depot and other stores nationwide and online, including Amazon.com…
Updated Oct 1About 77,000 (In addition, abou… units
The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury fro…
Hazard. The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury from fire and burn hazards.
What to do
Consumers should stop using the recalled hand warmers immediately and contact Kobayashi for a full refund
Consumers will be asked to go to https://hothands.com/recall-notice-rechargeable and follow the instructions to obtain a claim number
Consumers will also be asked to destroy the product by wr…
Gobi Heat Recalls Rechargeable Hand Warmers Due to Risk of Serious Injury from Fire and…
Sold Online At: GobiHeat.com from October 2024 through August 2026 for between $20 and $40.
Updated Oct 1About 5,500 (In addition, about… units
The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury fro…
Hazard. The lithium-ion battery and electrical components in the recalled hand warmers can overheat and ignite, posing a risk of serious injury from fire and burn hazards.
What to do
Consumers should stop using the recalled hand warmers immediately and contact Gobi Heat for a full refund or store credit, equal to full refund of the purchase price plus 20% of that amount
Consumers will be asked to go to https://gobiheat.com/pages/handwarmer-recall to obtain a claim number and i…
Gazelle USA Recalls Urban Arrow Cargo Electric Bikes Due to Fall Hazard
Gazelle USA, of Santa Cruz, California
Updated Oct 1About 1,032 (In addition, about… units
The front bolt in the seat post clamping mechanism can break, causing the seat to become loose, posing a fall hazard.
Hazard. The front bolt in the seat post clamping mechanism can break, causing the seat to become loose, posing a fall hazard.
What to do
Consumers should stop using the recalled bicycles immediately and contact Gazelle USA to receive a free replacement seat post and saddle that consumers can either install themselves with no special tools or take to an Urban Arrow dealer to be installed at no charge
Dollar Tree Stores Recalls Electric Balloon Pumps Due to Burn Hazard
Sold At: Dollar Tree stores nationwide and online at dollartree.com, and doordash.com between August 2025 and July 2026…
Updated Oct 1About 360,500 units
The recalled electric balloon pumps can overheat, posing a burn hazard.
Hazard. The recalled electric balloon pumps can overheat, posing a burn hazard.
What to do
Consumers should stop using the recalled electric balloon pumps immediately and return it to any Dollar Tree store to receive a full refund
Consumers who purchased the electric balloon pump online should contact the firm to receive a pre-paid shipping label to return the recalled product to receiv…
Sauna360 Expands Recall of Tylö Halmstad and Kiruna Hybrid Saunas Due to Fall Hazard; New…
SFactor (China)
Updated Sep 17About 6,000 (Sauna 360 previous… units
The saunas contain a bench that can collapse, posing a fall hazard to consumers. The previous recall repair was ineffective; a new repair i…
Hazard. The saunas contain a bench that can collapse, posing a fall hazard to consumers. The previous recall repair was ineffective; a new repair is now being offered.
What to do
Consumers should stop using the saunas immediately, even if they received the 2025 recall remedy and contact Sauna360 for another free repair
Sauna360 will provide a professional installer to retrofit the benches with additional hardware and supports
Daikin Comfort Technologies Manufacturing Recalls Amana Through-The-Wall Air Conditioners…
Daikin Comfort Technologies Manufacturing, of Houston, Texas
Updated Sep 3About 4,633 (In addition, about… units
The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
Hazard. The snubber circuit can emit flames if it shorts, posing a risk of serious injury due to fire hazard.
What to do
Consumers should stop using the recalled product immediately and contact Daikin Comfort Technologies Manufacturing, Inc. (DCT) to submit a request for a full refund of the unit
Consumers will be required to provide their contact information, cut the product’s cord, and then upload a photo of the…
Branch Recalls Ergonomic Chairs Due to Fall Hazard
Branch
Updated Sep 3About 16,000 (In addition, abou… units
The backrests of the chairs can detach, posing a fall hazard to consumers.
Hazard. The backrests of the chairs can detach, posing a fall hazard to consumers.
What to do
Consumers should stop using the recalled chairs immediately and contact Branch for a free repair kit consisting of a replacement backrest, installation instructions, three bolts and an Allen key
Consumers will be provided with instructions on how to determine if their backrests are included in the…
Cooluli Recalls 10-Liter and 15-Liter Minifridges Due to Fire and Burn Hazards
Ningbo Iceberg Electronic Appliance (China)
Updated Aug 13About 250,000 units
The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.
Hazard. The recalled minifridges' electrical switch can short circuit, posing fire and burn hazards.
What to do
Consumers should stop using the recalled minifridges immediately and contact Cooluli for a free replacement power cord
Consumers will be asked to visit www.cooluli.com/pages/product-notices-recalls to enter the model and batch numbers to determine whether their minifridge is included in the recall…
Costway Recalls Convertible High Chairs Due to Risk of Serious Injury or Death from…
Sold At: Walmart and Target stores nationwide and online at Costway.com from May 2023 through July 2026 for between $84…
Updated Oct 22About 3,332 units
The convertible high chairs violate the mandatory safety standard for high chairs because they do not contain a passive restraint system an…
Hazard. The convertible high chairs violate the mandatory safety standard for high chairs because they do not contain a passive restraint system and a child can slip through the opening between the feeding tray and seat and become entrapped or fall, posing a risk of serious injury or death.
What to do
Consumers should immediately stop using the recalled high chairs and contact Costway for a free replacement high chair
Consumers will be asked to provide a receipt or a photo of the product and will receive a prepaid label to return the recalled product to Costway
Romorgniz Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from…
Zhangzhou Jinhao Sen Smart Home (China)
Updated Oct 8About 12,078 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Romorgniz for a full refund
Consumers will be asked to write in permanent marker "RECALLED" on the top, front and sides of the dresser, …
GBYMIUY Recalls Magnetic Stick Figure Toy Sets Due to Risk of Serious Injury or Death…
GBYMIUY (China)
Updated Oct 1About 10,750 units
The magnetic stick figure toy sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an i…
Hazard. The magnetic stick figure toy sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, bl…
What to do
Consumers should take the stick figures away from children immediately, stop using them and contact GBYMIUY for a full refund
Consumers will be asked to throw away the stick figure toys and send a photo of the disposed toys to [email protected]
ABC Trading Recalls Squishy Toys Due to Risk of Serious Injury or Death from Water Bead…
ABC Trading, of Vernon, California
Updated Oct 1About 37,000 units
The squishy toys violate the mandatory safety standard for toys because the water beads inside the toys expand larger than permitted, posin…
Hazard. The squishy toys violate the mandatory safety standard for toys because the water beads inside the toys expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking, and intestinal obstruction hazards inside a child's body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
What to do
Consumers should stop using the squishy toys immediately and contact ABC Trading for a full refund
Consumers will be asked to write "RECALLED" in permanent marker on the squishy toys, throw the toy away and email a photo of the disposed toy to [email protected]
ZCK01 Recalls Kesyup Mattresses Due to Risk of Serious Injury or Death from Fire Hazard…
ZCK01 (China)
Updated Sep 24About 48,405 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattresses immediately and contact ZCK01 for a full refund
Consumers will be asked to destroy the mattress by writing in permanent marker “Recalled,” their name and the date on mattress’ top surface, and to email a photo of the destroyed mattress to k…
Yuyitop Recalls Aitjunz 8-Drawer Dressers Due to Risk of Serious Injury or Death from…
Dongguan Meiying Sen Smart Home (China)
Updated Sep 24About 25,073 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 contact yuyitop at [email protected] to receive a free retrofit kit containing counterweight blocks with inst…
ABC Trading Recalls Light-Up Children’s Toys Due to Risk of Serious Injury or Death from…
ABC Trading, of Vernon, California
Updated Sep 24About 43,674 units 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 recalled light-up toys immediately and contact ABC Trading for a refund
Consumers will be asked to email [email protected] a photograph showing the product being disposed of in the trash
Colerinsec Recalls Jerify Magnetic Stick Figure Toy Sets Due to Risk of Serious Injury or…
Colerinsec (China)
Updated Sep 17About 38,507 units
The magnetic humanoid toy Sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an inges…
Hazard. The magnetic humanoid toy Sets violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood …
What to do
Consumers should take the magnetic humanoid toys away from children immediately, stop using them and contact Colerinsec for a full refund
Consumers will be asked to throw away the magnetic toys and submit a photo of the disposed toys to [email protected]
Sweet Cubby Recalls Children's Loungewear Sets Due to Risk of Serious Injury or Death…
Sold Online At: SHEIN.com from June 2025 through May 2026 for between $8 and $12.
Updated Sep 10About 12,461 units
The recalled children’s loungewear sets violate the mandatory flammability standard for children’s sleepwear, posing a risk of serious burn…
Hazard. The recalled children’s loungewear sets 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 loungewear sets immediately, take them away from children and contact Sweet Cubby for a full refund
Consumers will be asked to destroy the loungewear sets by cutting them in half and send a photo of the destroyed loungewear sets to [email protected]
Prepared Hero Recalls Fire Spray Canisters Due to Risk of Serious Injury or Death from…
Prepared Hero, of Sheridan, Wyoming
Updated Sep 10About 31,000 units
The recalled fire spray canister can deteriorate overtime, causing it to rupture and fail to operate during a fire, posing the risk of seri…
Hazard. The recalled fire spray canister can deteriorate overtime, causing it to rupture and fail to operate during a fire, posing the risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the fire spray canisters immediately and visit www.preparedhero.com/pages/recall for instructions on how to receive a free replacement unit and how to properly dispose of the recalled fire spray canister according to local and state regulations
MONDRAKER USA Recalls Mountain Bicycles Equipped with ONOFF S9 Carbon MTB Handlebars Due…
MONDRAKER USA, of Boulder, Colorado
Updated Sep 3About 177 (In addition, about 5… units
The affected handlebars may crack or fracture during use, which can lead to loss of control, posing a risk of serious injury or death from …
Hazard. The affected handlebars may crack or fracture during use, which can lead to loss of control, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using affected bicycles immediately and verify whether their bicycle is affected using the serial number verification tool available at: https://mondraker.com/wo/en/recall-s9
If the bicycle is identified as affected, consumers should contact an authorized Mondraker dealer to …
Montessori Baby Toy Sets Recalled Due to Risk of Serious Injury or Death from Choking…
Chillife Official
Updated Aug 27About 20,134 units
The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings ar…
Hazard. The recalled baby toy sets contain a pull string teething toy that violates the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The silicone strings can reach the back of children’s throat and become lodged, posing a risk of respiratory distress and deadly choking hazard.
What to do
Consumers should stop using the pull string teether toys immediately, take them away from children and contact Chillife Official for a partial refund of $5.40
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker “DESTROYED” on the main body…
Diamond Wipes International Recalls MD Wipe Outz Numbing Tattoo Wipes Due to Risk of…
Diamond Wipes International, of Chino, California
Updated Aug 27About 55,250 units
The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Ac…
Hazard. The recalled numbing wipes contain lidocaine, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The packaging of the wipes is not child-resistant, posing a risk of serious injury or death from poisoning if the contents of the wipes are ingested by young children.
What to do
Consumers should secure the wipes out of sight and reach of children immediately and contact Diamond Wipes for a full refund
Consumers will be asked to write “RECALLED” on the packet and send a photo of the marked packet to [email protected]
TooyBing Wooden Bead Stacking Toys Recalled Due to Risk of Serious Injury or Death from…
Guangzhou Yide Toys (China)
Updated Aug 13About 21,758 units
The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a dead…
Hazard. The recalled toys violate the small parts ban because they are intended for children under three years old and the wooden beads pose a deadly choking hazard to young children.
What to do
Consumers should stop using the toys immediately, take them away from children, and contact TooyBing for free replacement
Consumers will be asked to destroy the toys by cutting the red and yellow string laces, writing in permanent marker "RECALLED" on the top of the wooden pegged stand and send a …
Southern Telecom Recalls Brookstone-Branded Tabletop Fire Pits Due to Risk of Serious…
Southern Telecom, of Brooklyn, New York
Updated Aug 13About 48,700 units
Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as fl…
Hazard. Use of the fire pits can result in uncontrolled pool fires where flames burn across the surface of pooled or spilled alcohol, as well as flame jetting from fuel containers, resulting in serious or fatal burns.
What to do
Consumers should stop using the Brookstone-branded Tabletop Fire Pits immediately and contact Southern Telecom to receive a full refund
Consumers can email a photo of the fire pit with "Recalled," their name, and the date written on it in permanent marker to [email protected] and then…
Trsmima Zipline Kits and Zipline Spring Brakes Recalled Due to Fall and Collision…
HuNanBoLuoDianZiShangWuYouXianGongSi D/B/A Trsmima or Hunan Pineapple Electronic Commerce (China)
Updated Jul 30About 60,720 zipline kits and a… units
The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not …
Hazard. The zipline kit's steel cable, turnbuckle and seat can detach or break during use, posing a fall hazard. The zipline spring brakes are not stiff enough to safely slow a rider down and the kit design does not include an emergency brake, posing collision and fall hazards.
What to do
Consumers should stop using the TT Trsmima zipline kits and zipline spring brakes immediately and contact Trsmima for a full refund
Consumers will be asked to uninstall the zipline kits and destroy them by cutting the safety belt, seat rope and if included in their model, rachet strap, in half and…
Joyin Expands Recall of Sloosh Dive Sticks Due to Risk of Serious Injury from Impalement…
Joyin US, of Chandler, Arizona
Updated Jul 30About 404,000 (Joyin previously… units
The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shal…
Hazard. The recalled dive sticks violate the federal dive sticks ban because they exceeded the compress limit, posing an impalement hazard. In shallow water, children may fall or land on a dive stick, resulting in serious piercing injuries. Facial and eye injuries are also possible when children attempt to retrieve the sticks underwater.
What to do
Consumers should stop using the recalled dive sticks immediately, take them away from children and dispose of them
Consumers will be asked to take a photo of the disposed dive sticks in the trash and email it to Joyin at [email protected]
Once received, Joyin will send the consumer redesigned div…
Jake's Fireworks Recalls World Class Fireworks "Skull Strobe" Rockets Due to Risk of…
Jake's Fireworks, of Pittsburg, Kansas
Updated Jul 30About 132,440 units
The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards.
Hazard. The recalled fireworks rockets can explode prematurely before reaching their intended height, posing explosion and burn hazards.
What to do
Consumers should stop using the fireworks rockets immediately and contact Jake's Fireworks for a full refund
Consumers will be asked to return the fireworks devices to the retail location where they purchased the product or the nearest Jake's Fireworks retail location
Vanderhall North America Recalls All Model Year 2024-2026 Brawley Electric Recreational…
Vanderhall North America, of Provo, Utah
Updated 4 days agoAbout 190 units
The seat belts in Brawley ROVs can permanently lockup in the fully retracted position. If this occurs, consumers would be unable to reset t…
Hazard. The seat belts in Brawley ROVs can permanently lockup in the fully retracted position. If this occurs, consumers would be unable to reset the seat belt and put it on when the vehicle is operating, posing injury and crash hazards to consumers.
What to do
Consumers should stop using the recalled vehicles immediately and contact an authorized Vanderhall dealer to schedule a free repair
A technician will install an insert into the seat belt guide slot on each seat that will reduce the speed the seat belt retracts, preventing the lockup from occurring
SOOWERY Recalls 8-Drawer Fabric Dressers Due to Risk of Serious Injury or Death from…
Sold Online At: Amazon.com from December 2025 through August 2026 for about $106.
Updated Oct 29About 138 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact SOOWERY for a full refund
Consumers will be asked to write in permanent marker “RECALLED” on the top, front and sides of the dresser…
Longjili Trading Recalls Pamag Pieeoo Mattresses Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com in March 2026 for between $80 and $95.
Updated Oct 29About 50 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattresses immediately and contact Longjili Trading for a full refund
Consumers will be asked to destroy the mattress by writing in permanent marker “RECALLED,” on the top surface of the mattress and send a photo of the marked mattress to Pamagpieeoo@ou…
VQQQ Gas Patio Heaters Recalled Due to Risk of Serious Injury or Death from Fire and Burn…
Sold Online At: Amazon.com from July 2024 through August 2026 for about $346.
Updated Oct 22About 100 units
Components on the recalled patio heaters can malfunction, causing gas to be released, posing a risk of serious injury or death from fire an…
Hazard. Components on the recalled patio heaters can malfunction, causing gas to be released, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled patio heaters immediately, shut the valve at the portable gas source, disconnect the gas hose and contact VQQQ for a full refund
Consumers will be asked to write in permanent marker "Recalled" on the heater's base and send a photo of the marked heater to vq…
FoShanShiNanHaiQuNuoAiTongZhuangShangHang Recalls CIYTI Light-Up Princess Costumes Due to…
Sold Online At: Amazon from February 2025 through June 2025 for between $21 and $35.
Updated Oct 22About 94 units
The costumes violate the mandatory safety standard for toys because the button cell batteries can be accessed easily by children, posing a …
Hazard. The costumes violate the mandatory safety standard for toys because the button cell batteries can be accessed easily by children, posing a deadly ingestion hazard. 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 princess costumes away from children immediately, stop using them and contact FoShanShiNanHaiQuNuoAiTongZhuangShangHang for a full refund
Consumers will be asked to write "RECALLED" with permanent marker on the dress, crown, wand, and remote, then throw away the toys and …
usOpal Recalls Xalirium Portable Bed Rails Due to Risk of Serious Injury or Death from…
usOpal (China)
Updated Oct 15About 200 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. The bed rails do not meet structural stability or retention strap requirements, posing a fall h…
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact usOpal for a full refund
Consumers will be asked to cut the black storage bag and straps and to cut the foam padding on the bed rails, write "RECALLED" on the upper and lower bed rails, and send a photo of th…
Papablic, of USA Recalls Convertible Bedside Sleepers Due to Risk of Serious Injury or…
Sold Online At: Amazon.com and papablic.com from April 2025 through July 2026 for about $190.
Updated Oct 15About 248 units
The bedside sleepers with play yard extensions violate the mandatory safety standard for play yards because the mattress can become displac…
Hazard. The bedside sleepers with play yard extensions violate the mandatory safety standard for play yards because the mattress can become displaced, causing a baby to become entrapped between the sleeping pad and bottom posing a deadly suffocation hazard. In addition, the latching and locking mechanism can fail, causing the product to collapse, posing a risk of serious injury or deadly entrapment and f…
What to do
Consumers should stop using the convertible bedside sleeper immediately and contact Papablic for a refund
Consumers will be asked to disassemble the product, cut the mattress and fabric components in half and email photos of the destroyed components to [email protected]
Walmart Recalls Over 4.4 Million Expert Grill Brushes Due to Ingestion Hazard
Walmart of Bentonville, Arkansas
Updated Oct 1About 4,477,655 units
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious intern…
Hazard. Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
What to do
Consumers should stop using the recalled grill brushes immediately and contact Walmart for a full refund or a credit for use at any Walmart store or Walmart.com
Consumers will be asked to return their recalled brushes to Walmart or discard them
Char-Broil Recalls Bistro Pro Electric Grills Due to Risk of Electric Shock
Char-Broil, of Columbus, Georgia
Updated Sep 17About 10,605 (In addition, 342 … units
The grounding wire for the grill's heating element can disconnect and lose fault protection, posing an electric shock hazard.
Hazard. The grounding wire for the grill's heating element can disconnect and lose fault protection, posing an electric shock hazard.
What to do
Consumers should stop using the recalled electric grills immediately and contact Char-Broil for a free repair kit
Consumers will be asked to register at www.charbroil.com/BistroProFix to receive repair instructions, a screwdriver, a wrench, screws and a label to affix to the grill after repair
Conair Expands Recall of Cuisinart Grill Brushes Due to Ingestion Hazard; Over 3.6…
Conair of Stamford, Connecticut
Updated Aug 27About 1,905,805 additional brus… units
Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious intern…
Hazard. Small metal wire bristles can detach from the brushes and stick to the grill or food, posing an ingestion hazard and risk of serious internal injuries that could require surgery.
What to do
Consumers should stop using the recalled grill brushes immediately and contact Conair for a full refund or a credit for use at Cuisinart.com for a full refund plus 20% of the cash refund amount
Consumers will be asked to discard the recalled grill brushes
Modine Manufacturing Company Recalls Airedale Heating and Cooling Ventilation Fans Due to…
Modine Manufacturing, of Racine, Wisconsin
Updated Aug 20About 6,061 (In addition, about… units
The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing …
Hazard. The ventilation fan motor in the heat pumps can short circuit if water gets on the circuit board, causing the units to overheat and posing a fire hazard.
What to do
Consumers should stop using the recalled heat pumps immediately and contact Modine Manufacturing Company for written instructions to unplug the recalled ventilation fan or to switch the internal disconnect in the fan to the "off" position
Consumers should contact their Modine distributor to arrang…
OKK Trading Recalls Easter LED Headbands Due to Risk of Serious Injury or Death from…
OKK Trading, of Vernon, California
Updated Aug 6About 25,200 units
The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batterie…
Hazard. The recalled headbands violate the mandatory safety standard for toys with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, internal chemical burns, and death.
What to do
Consumers should stop using the Easter LED Headbands immediately and contact OKK Trading for a refund
Consumers will be asked to email [email protected] a photograph showing the product being properly disposed of in the trash
Liuqibax Adult Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
Luqiba (China)
Updated Aug 6About 12,000 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.
What to do
Consumers should stop using the recalled bed rails immediately and contact Luqiba for a full refund
Consumers will be asked to destroy the bed rails by dismantling them, cutting off the safety strap and storage bag and writing in permanent marker "RECALLED" on the upper and lower rails, and email …
Woodure Toddler Kitchen Step Stools Recalled Due to Risk of Serious Injury and Death from…
Shenzhen Muqiqu Creative Development (China)
Updated Jul 30About 91,000 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled tower stools immediately and store them away from children
Contact Shenzhen Muqiqu Creative Development for a repair kit, which includes protective nets, stabilizing feet and installation instructions
The firm will mail the free repair kit directly to cons…
HARPPA Recalls Nordi Toddler Tower Stools Due to Risk of Serious Injury and Death from…
HARPPA, of Denver, Colorado
Updated Jul 3047,166 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled stools immediately and store them away from children
Contact HARPPA for a free repair kit, including shipping
The repair kit consists of protective nets, stabilizing feet and installation instructions
Golden Link Recalls Fantastic Four Cups and Captain America Popcorn Helmet Containers…
Golden Link, of Middletown, New York
Updated Jul 30About 55,350 units
The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain butto…
Hazard. The cups and containers violate the mandatory standard for consumer products with button cell and coin batteries because they contain button cell batteries that can be accessed easily by children, posing an ingestion hazard. In addition, the products do not bear the warning labels required by Reese's Law. If button cell or coin batteries are swallowed, the ingested batteries can cause serious inj…
What to do
Consumers should stop using the Fantastic Four Cups and Captain America Popcorn Helmet Containers immediately and contact Golden Link for a refund of the purchase price of the product
Consumers will be asked to dispose of the product and send a photo showing proof of disposal to productrecall@gold…
15-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
Changzhou Jiaxuan Intelligence Furniture (China)
Updated Jul 30About 12,800 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact EnHomee-Direct for instructions on how to identify affected units and dispose of the dressers to receive a full refund
The lithium-ion battery in the power banks can explode or ignite, posing fire and burn hazards to consumers.
Hazard. The lithium-ion battery in the power banks can explode or ignite, posing fire and burn hazards to consumers.
What to do
Consumers should stop using the recalled power banks immediately and contact NEWDERY for instructions on how to receive a full refund
To receive a refund, consumers will be required to submit a photo of their recalled power bank showing the model number, serial number and the word “recalled” a…
Melissa & Doug Recalls Fire Truck Activity Board Toys Due to Risk of Serious Injury from…
Melissa & Doug, of Wilton, Connecticut
Updated Sep 17About 84,000 units
The fire hose port can come loose and detach, posing a risk of serious injury from choking hazard.
Hazard. The fire hose port can come loose and detach, posing a risk of serious injury from choking hazard.
What to do. Consumers should stop using the fire truck activity board immediately and register at www.melissaanddoug.com/recall for instructions on how to receive a free replacement fire truck activity board, register for a full refund of $30 in the form of a check or receive a $40 melissaanddoug.com store cre…
Goal Zero Recalls YETI 3000X Power Stations Due to Serious Risk of Injury from Fire and…
Goal Zero, of Draper, Utah
Updated Aug 20About 46,200 units
The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
Hazard. The recalled power station's circuit board can overheat, posing a risk of serious injury from fire and burn hazards.
What to do. Consumers should stop using the power stations immediately and install the free repair in the form of a firmware update available through the Goal Zero application or contact Goal Zero for firmware installation at no cost.
ONTHEWEI Recalls Baby Bath Seats Due to Risk of Serious Injury or Death to Children from…
Sold Online At: Amazon.com in April 2026 for between $40 and $50.
Updated Oct 8About 2,140 units
The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posin…
Hazard. The recalled bath seats violate the mandatory standard for infant bath seats because they are unstable and can tip over while in use, posing a risk of serious injury or death due to drowning.
What to do
Consumers should stop using the recalled bath seats immediately and contact ONTHEWEI for a full refund
Consumers will be asked to destroy the bath seat by writing in permanent marker "RECALLED" on the front of the bath seat, disassembling it by removing the back rest and arm restraints and cutting…
Decathlon America Recalls Van Rysel GRVL AF Bicycles Due to Risk of Serious Injury or…
Decathlon America, of San Francis, California
Updated Oct 8About 1,150 units
The recalled bicycles' front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard.
Hazard. The recalled bicycles' front lock nut can loosen during use, causing the front wheel to dislodge or loosen over time, posing a crash hazard.
What to do
Consumers should stop using the recalled bicycles immediately and take them to the nearest Recreational Equipment (REI Co-op) location for a free inspection and repair service of the front fork assembly
Anyone unable to visit an REI Co-op location can contact Decathlon Customer Service directly fo…
Hayward Industries Recalls Universal Pool Heaters Due to Risk of Serious Injury or Death…
Hayward Industries, of Charlotte, North Carolina
Updated Sep 17About 4,600 units
During operation, the heaters can produce high levels of carbon monoxide (CO), posing a risk of serious injury or death from carbon monoxid…
Hazard. During operation, the heaters can produce high levels of carbon monoxide (CO), posing a risk of serious injury or death from carbon monoxide poisoning.
What to do. Consumers should stop using the pool heater immediately and contact Hayward Industries to schedule a free in-home inspection and repair by a qualified technician.
Friedrich Air Conditioning Recalls KÜHL Window Air Conditioners Due to Risk of Serious…
Friedrich Air Conditioning, of San Antonio, Texas
Updated Sep 17About 2,000 units
The control board inside the motor of the recalled air conditioners can fail, posing a risk of serious injury or death from fire and burn h…
Hazard. The control board inside the motor of the recalled air conditioners can fail, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled air conditioners immediately and visit www.friedrich.com/product-recall to receive information on how to determine if their unit is covered by the recall
Consumers should have the air conditioner’s serial number, which can be found on the inside of the un…
Junkins Recalls DHASUWT Hair Dryer Brushes Due to Risk of Serious Injury or Death from…
Sold At: Amazon.com from October 2024 through June 2026 for about $27
Updated Sep 10About 1,738 units
The recalled hair dryer brushes lack an integrated immersion protection device, which presents a substantial product hazard to consumers, p…
Hazard. The recalled hair dryer brushes lack an integrated immersion protection device, which presents a substantial product hazard to consumers, posing the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in to an electrical source. The recalled hair dryer brushes also pose the risk of death or serious injury from smoking and fire hazards.
What to do
Consumers should unplug and stop using the recalled hair dryers immediately and contact Junkins to receive a full refund
Consumers will be asked to cut the power cord and provide a photo of the destroyed product to [email protected]
Guang Zhou Recalls Wantefully Hair Dryer Brushes Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com from February 2026 through March 2026 for about $30.
Updated Sep 10About 2,295 units
The recalled hair dryer brushes are in violation of federal regulations for hair dryers as they lack an integrated immersion protection dev…
Hazard. The recalled hair dryer brushes are in violation of federal regulations for hair dryers as they lack an integrated immersion protection device, which presents a substantial product hazard to consumers and the risk of death or serious injury from electrocution or shock if the hair dryers fall into water while plugged in. In addition, the recalled hair dryer brushes can overheat, posing a burn haza…
What to do
Consumers should unplug and stop using the recalled hair dryers immediately and contact Guang Zhou to receive a full refund
Consumers will be asked to cut the power cord and provide a photo of the destroyed product to [email protected]
FJTJBSI Recalls Six-Drawer Dressers Due to Risk of Serious Injury or Death from Tip-Over…
Sold Online At: Amazon.com from November 2024 through July 2026 for about $170.
Updated Sep 10About 9,000 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, place them in an area that children cannot access and contact FJTJBSI for a full refund
Consumers will be asked to write in permanent marker “RECALLED” on the dresser and send a photo of the mar…
OKK Trading Recalls Rainbow Mystery Squishy Bun Toys Due to Risk of Serious Injury or…
OKK Trading, of Vernon, CA
Updated Sep 3About 7,200 units
The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitt…
Hazard. The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
What to do
Consumers should stop using the squishy dumpling toys immediately and contact OKK Trading for a full refund
Consumers will be asked to write “RECALLED” in permanent marker on the squeezy dumpling and its tan plastic container, throw the toy away, and email a photo of the disposed toy to recall…
Gizoon Direct Recalls Six-Drawer Double Dressers Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com from May 2025 through August 2026 for between $138 and $171.
Updated Sep 3About 4,396 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Gizoon Direct for a full refund
Consumers will be asked to write in permanent marker "RECALLED" on the top and all sides of the dresser …
GIHNJSI Squeezy Dumplings Toys Recalled Due to Serious Ingestion, Choking and Obstruction…
Sold Online At: Amazon.com from May 2026 through June 2026 for about $20.
Updated Sep 3About 8,000 units
The squeezy toys contain water beads. If ingested, water beads expand and can pose deadly ingestion, choking, and intestinal obstruction ha…
Hazard. The squeezy toys contain water beads. If ingested, water beads expand and can pose deadly ingestion, choking, and intestinal obstruction hazards inside a child’s body, resulting in severe discomfort, vomiting, dehydration, and a risk of death to a child.
What to do
Consumers should stop using the Squeezy Dumplings toys immediately and contact Chenyuanhui for a full refund
Consumers will be asked to write “RECALLED” in permanent marker on the Squeezy Dumpling and on its tan plastic container, throw the toy away and email a photo of the disposed toy to GIH…
Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment…
Sold Online At: Amazon.com from June 2025 through April 2026 for between $40 and $50.
Updated Sep 3About 2,200 units
The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail o…
Hazard. The recalled bed rails violate the mandatory standard for adult portable bed rails because users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. The bed rails also do not meet retention strap requirements, posing a fall hazard. The bed rails’ push pins and push pin holes are …
What to do
Consumers should stop using the recalled adult portable bed rails immediately and contact Loyoda for a full refund
Consumers will be asked to cut the black safety strap in half and write “RECALLED” on the upper and lower bed rails with a permanent marker, take a photo of the marked bed rail an…
HABA USA Recalls Rainbow Rattle Grasping and Teething Toys Due to Risk of Serious Injury…
HABA USA
Updated Aug 27About 2,000 units
The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plasti…
Hazard. The glued knot on the elastic cord can become untied on the recalled product, allowing young children access to the small wooden and plastic pieces, posing a risk of serious injury or death from choking and ingestion hazards.
What to do
Consumers should stop using the rattle grasping and teething toy immediately, take it away from children and contact HABA USA to receive a full refund
Consumers will be asked to destroy the toy by cutting the elastic cord, taking a photo of it and uploading a photo of the destroyed toy with their …
JINHEZO Mini Waterproof LED Tea Lights Recalled Due to Risk of Serious Injury or Death…
Mystic ZO (China)
Updated Aug 20About 2,798 units
The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batte…
Hazard. The LED Tea Lights violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause serious injurie…
What to do
Consumers should stop using the recalled LED Tea Lights immediately and contact Mystic Zo for a full refund
To receive a refund, consumers will be asked to email their order number or bar code number, if available, along with a photo of the tea lights disposed of in the trash to jinhemaoyi2016@sin…
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories, Hand Pendants…
Medline Industries, LP
Updated Aug 14771,127 total units
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overh…
Hazard. Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED…
Medline Industries, LP
Updated Aug 14771,127 total units
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overh…
Hazard. Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, sparking, melting, burning, or fire. Additional products added to 11/26/2025 recall.
GigaCloud Technology USA Recalls Merax Murphy Beds Due to Risk of Serious Injury or Death…
GigaCloud Technology (USA), of El Monte, California
Updated Aug 13About 1,250 units
During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.
Hazard. During assembly or disassembly, the frame of the wall bed can fall onto consumers, posing deadly impact, crush and laceration hazards.
What to do
Consumers should stop using the recalled Murphy beds immediately and contact GigaCloud Technology for a free repair kit
Consumers that have not assembled the Murphy bed will receive a repair kit consisting of unloaded piston springs, updated assembly instructions and inspection instructions
DUMOS Nine-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over…
Jiangsu Jiayubo Furniture (China)
Updated Aug 13About 8,981 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should immediately stop using the recalled dressers if they are not anchored to the wall and place them in an area that children cannot access
Consumers should contact DUMOS for a full refund
Consumers will be asked to destroy the dressers by cutting the drawers in half and writing in p…
Deli Jerry Fuel Containers Recalled Due to Risk of Serious Injury or Death from Burn…
Online at Walmart.com from April 2025 through June 2026 for about $36.
Updated Aug 13About 1,750 units
The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not chi…
Hazard. The recalled fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act. The closure is not child-resistant, posing a risk of burns and poisoning to children.
What to do
Consumers should stop using the recalled fuel containers immediately and contact Deli OfficeSupplies for a full refund
Consumers will be asked to destroy the fuel container by writing in permanent maker "RECALLED" on the product and to send a photo of the destroyed fuel container to service@steeli…
COMMOWNER Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
AZ Home Concept (China)
Updated Aug 131,694 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encoura…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact AZ Home Concept for a full refund
Consumers will be asked to destroy the pressure washer by cutting the unplugged power cord in half and send a photo of the destroyed power washer to [email protected].…
PUMPKIN SPICE NO BAKE COOKIE NET WT 3.5 oz. INGREDIENTS: WHOLE GRAIN OATS, MILK…
Best Friends Bakery
Updated Aug 171,416/3.5oz cookies units
Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed i…
Hazard. Peanuts & Eggs. The firm list peanuts in the ingredient statement but omitted them from the contain statement. They also have eggs listed in the contain statement but there are no eggs in the product.
Bodum USA Recalls 5.9 Million French Press Coffee Makers with Replaceable Glass Carafes…
Bodum USA, of New York, New York
Updated Oct 295.9 million units
The carafe can unexpectedly break during use if the glass carafe is damaged or cracked, including by use of a metal spoon to stir the coffe…
Hazard. The carafe can unexpectedly break during use if the glass carafe is damaged or cracked, including by use of a metal spoon to stir the coffee, posing a risk of serious burn injuries.
What to do
Consumers should stop using metal spoons or utensils to stir coffee in the glass carafe immediately and contact Bodum to receive a plastic Bodum stirring spoon and warning label
The label reminds consumers not to use cracked or damaged carafes and not to use metal spoons to stir contents in the gl…
Loving Thyself Rocks Recalls Crystal Glass Cups Due to Risk of Serious Injury from…
Sold At: Loving Thyself store and on-line at https://www.instagram.com/lovingthyselfrocksandfossils/?hl=en and https://…
Updated Oct 15About 600 units
Glass can break inside the recalled cups while in use, posing a risk of serious injury from ingestion and laceration hazards.
Hazard. Glass can break inside the recalled cups while in use, posing a risk of serious injury from ingestion and laceration hazards.
What to do
Consumers should stop using the recalled crystal cup immediately and register at http://www.lovingthyselfrocks.com/recall to receive a full refund in the form of original payment
Consumer will be asked to fill out an online form and submit a photograph with the word "RECALL" written on the front o…
Primark Recalls 101 Dalmatians Faux Leather Children’s Coin Purses Due to Phthalate…
Primark US, of Boston, Massachusetts
Updated Oct 15About 2,100 units
The coin purses contain higher phthalate concentration levels. Phthalates can be harmful if young children are exposed to sufficient amount…
Hazard. The coin purses contain higher phthalate concentration levels. Phthalates can be harmful if young children are exposed to sufficient amounts, including through ingestion, and certain phthalates have been associated with adverse health effects, particularly effects on development and the hormone system.
What to do. Consumers should stop using the coin purses immediately, keep them away from children and return them to a Primark store for a full refund in the original form of payment.
Char-Broil Recalls Bistro Pro Electric Grills Due to Risk of Electric Shock
Char-Broil, of Columbus, Georgia
Updated Sep 17About 10,605 (In addition, 342 … units
This recall involves the Charbroil Bistro Pro Electric Grills with model descriptions Bistro Pro Electric Grill & Griddle + Charcoal, Bistro Electric Grill + Charcoal and Bistro Pro Tabletop Electric Grill. The grills were sold in full-size and tabletop configurations in Black (black and gray), Red, Blackout (all black) and Emerald (green). The units have a “CB” logo plate on the front of the lid and “CHARBROIL” printed on the front control panel. The product label listing the model and serial number, including a four‑digit manufacturing date code in year and month (YYMM) format, is…
What to do
Consumers should stop using the recalled electric grills immediately and contact Char-Broil for a free repair kit
Consumers will be asked to register at www.charbroil.com/BistroProFix to receive repair instructions, a screwdriver, a wrench, screws and a label to affix to the grill after repair
Wnttmt Baby Walkers Recalled Due to Risk of Serious Injury or Death from Fall and…
Online at Amazon.com from February 2026 through March 2026 for between $65 and $75.
Updated Aug 6About 1,310 units
The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to s…
Hazard. The recalled infant walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard. In addition, the infant walkers have leg openings that allow the child to slip down until the child's head can become entrapped, posing a risk of serious injury or death.
What to do
Consumers should stop using the recalled infant walkers immediately and contact WURUI.BABY for a full refund
Consumers will be asked to disassemble the walker, cut the fabric seat, write "Recalled" on the top of the tray in permanent marker and send a photo of the recalled infant walker to wbabywa…
Wichard Groupe North America Recalls Courant Spliced Kalimba Climbing Ropes Due to Risk…
Courant, of Angers, France
Updated Aug 6About 1,050 units
The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard.
Hazard. The spliced termination ends on the recalled ropes can fail unexpectedly, posing a risk of serious injury or death from fall hazard.
What to do
Consumers should stop using the recalled ropes immediately and contact Wichard Groupe North America for a free replacement rope, including shipping
Consumers will be asked to complete the registration form at https://www.wichardgroupe.us/news/post/recall-spliced-kalimba to receive a pre-paid shipp…
Play Yard and Crib Mattresses Recalled Due to Risk of Serious Injury or Death from…
Voomf (China)
Updated Aug 6About 2,401 units
The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain pla…
Hazard. The recalled mattresses violate the mandatory safety standard for crib mattresses because the mattresses may not adequately fit certain play yards, posing a deadly entrapment hazard. Babies can suffocate in gaps between an undersized mattress, or extra padding, and side walls of a product, especially when the infant's face becomes trapped against the side and the mattress, preventing the infant f…
What to do
Consumers should stop using the mattresses immediately and contact Voomf for a full refund
Consumers will be asked to destroy the mattresses by writing in permanent marker "Recalled," cutting the play yard mattress in half and cutting the full-sized mattress cover diagonally across the entire matt…
Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet…
Shenzhen Yuejia Mei Maoyi Youxian Gongsi (Shenzhen Yuejia Mei Trading), doing business as BUSOHA (China)
Updated Aug 6About 2,186 units
The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to c…
Hazard. The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poisoning and de…
What to do
Consumers should take the fidget sliders away from children, stop using them immediately and contact BUSOHA for a full refund
Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to [email protected] to receive a refund
Little Rawr Pull String Teething Toys Recalled Due to Risk of Serious Injury or Death…
Online at Amazon.com from September 2025 through April 2026 for between $11 to $15.
Updated Aug 6About 2,180 units
The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The …
Hazard. The recalled teething toys violate the mandatory standard for toys because the silicone strings are smaller and longer than permitted. The strings can reach the back of children's throat and become lodged, posing a serious risk of respiratory distress and a deadly choking hazard.
What to do
Consumers should stop using the teething toy immediately, take it away from children and contact Okabesini-us to receive a full refund
Consumers will be asked to destroy the toy by cutting all silicone strings and writing in permanent marker "RECALLED" on the main body of the toy and send a photo …
KC Imports and Exports Recalls Mini Laser Pointer Keychains Due to Risk of Serious Injury…
KC IMPORTS AND EXPORTS, of Vernon, California
Updated Aug 69,600 units
The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because th…
Hazard. The Mini Laser Pointer Keychains violate the mandatory safety standard for consumer products with button cell and coin batteries because the button batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause s…
What to do
Consumers should stop using the recalled laser keychains immediately and contact KC Import and Export for refund
To receive a refund, email a photo of the products disposed of in the trash to [email protected]
Head Watersports Recalls Apeks Second Stage Scuba Regulators Recalled Due to Risk of…
Head Watersports of Delray Beach
Updated Aug 6About 1,105 units
The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk …
Hazard. The recalled second stage regulators can restrict air flow to the user at depths exceeding 45 meters (approximately 147 feet), posing risk of serious injury or death from a drowning hazard.
What to do. Consumers should stop using the recalled second stage scuba regulators immediately and bring the product to any HEAD Watersports Authorized Retailer who will replace the valve spindle assembly at no cost to the consumer.
DR Power Equipment Recalls Lawn Mowers Due to Risk of Serious Injury or Death from…
Generac Power Systems, of Waukesha, Wisconsin
Updated Aug 6About 320 (In addition, 9 were … units
The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blad…
Hazard. The recalled mowers violate the mandatory safety standard for walk-behind power lawn mowers because the blades can operate without the blade control system engaged or continue to operate even after the release of the control, posing a serious laceration hazard.
What to do
Consumers should stop using the recalled mowers immediately unless they have already received a free repair kit in the mail from DR Power and it has been installed
If the repair kit has not been installed, contact DR Power to receive updated repair instructions or schedule a free repair from an au…
A2batt Recalls EEMB Lithium Coin Battery Chargers Due to Risk of Serious Injury or Death…
Online at Amazon.com from August 2024 through March 2026 for about $14.
Updated Aug 6About 4,930 units
The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the ch…
Hazard. The recalled battery chargers violate the mandatory standard for consumer products containing button cell or coin batteries, because the charger has lithium coin batteries that can be accessed easily by children. In addition, the coin batteries provided with the battery charger are not in child-resistant packaging, and the packaging does not have the warnings, as required by Reese's Law. When but…
What to do
Consumers should stop using the charger immediately, remove the batteries and place them in an area that children cannot access
Contact A2batt to receive a full refund
Consumers will be asked to write "RECALL" on the charger
If batteries remain in packaging, dispose of the batteries according to…
Mommy's Baby Lovely Deluxe Baby Doll Playsets Recalled Due to Risk of Serious Injury or…
Online at Temu.com from August 2024 through November 2025 for about $31.
Updated Jul 30About 1,034 units
The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories …
Hazard. The recalled doll playsets violate the small parts ban because the toys are for children under three years old and some of the accessories are small parts, posing a deadly choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children, and contact TOYHW for a full refund
Consumers will be asked to throw away the baby doll playset and email a photo of the disposed product to [email protected] to receive a full refund
5-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and…
Online at Amazon.com from September 2023 through June 2026 for about $180.
Updated Jul 30About 1,980 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact KAIFAM for instructions on how to identify affected units and receive a full refund
Consumers will be asked to write "RECALLED" on the t…
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx…
ARGATROBAN
Updated Oct 1318,991 vials units
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material…
Hazard. Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (…
Hazard. Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term s…
Hazard. Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
The Conqueror Recalls Avengers Medals Due to Risk of Serious Injury or Death from Magnet…
Sold Online At: www.theconqueror.events and through The Conqueror App from March 2026 through May 2026 for about $50.
Updated Oct 8About 476 units
The recalled medals violate the mandatory safety standard for magnets because the high-powered magnets may detach, posing a deadly ingestio…
Hazard. The recalled medals violate the mandatory safety standard for magnets because the high-powered magnets may detach, 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, twisting, and/or blockage of the intestines, blood poi…
What to do
Consumers should stop using the Avengers Infinity Gauntlet Medal immediately and contact The Conqueror for instructions on receiving a full refund or a replacement medal
Consumers will be asked to cut the ribbon from the medal and write "RECALLED" in permanent marker on the medal and ribbon, throw…
Snow Peak Recalls Propane Fireplace Inserts and Lava Rocks Due to Risk of Serious Injury…
Snow Peak USA, of Portland, Oregon
Updated Oct 8About 100 units
The fireplace's lava rocks can ignite and explode when heated in the propane insert, posing a risk of serious injury or death from burn and…
Hazard. The fireplace's lava rocks can ignite and explode when heated in the propane insert, posing a risk of serious injury or death from burn and fire hazards.
What to do
Consumers should stop using the propane insert and lava rocks fireplace accessories immediately and contact Snow Peak for a full refund
Consumers will be provided with a prepaid shipping label to return the propane insert and lava rocks
For replacement lava rocks only, the consumer can keep the p…
YunHeng Recalls LandTale Bed Rails Due to Risk of Serious Injury or Death from Entrapment…
Sold Online At: Amazon.com from February 2026 to June 2026 for about $43.
Updated Oct 1About 730 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 YunHeng for a full refund
Consumers will be asked to destroy the bed rail by cutting off the handle's foam grip, disassembling the product and writing in permanent marker "RECALLED" on the upper and lower rai…
LLK Trading Recalls Mochi Malrang Mystery Dumpling Toys Due to Risk of Serious Injury or…
Sold At: Easy Wholesale in San Jo, California in July 2026 for about $10.
Updated Oct 1About 480 units
The mystery dumpling toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than pe…
Hazard. The mystery dumpling toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking, and intestinal obstruction hazards inside a child's body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
What to do
Consumers should stop using the mystery dumpling toys immediately and contact LLK Trading for a full refund
Consumers will be asked to write "RECALLED" in permanent marker on the squeezy dumpling and its tan plastic container, throw them away, and email a photo of the items in the trash to llktrad…
Golden Resale Recalls Portable Camping Showers Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com and Walmart.com from February 2026 through August 2026 for about $60.
Updated Oct 1About 400 units
The recalled camping showers' immersion heaters can quickly ignite when they are partially or completely out of water, posing a risk of ser…
Hazard. The recalled camping showers' immersion heaters can quickly ignite when they are partially or completely out of water, posing a risk of serious injury or death from a fire hazard.
What to do
Consumers should stop using the Portable Camping Showers immediately and contact Golden Resale toll-free at 855-927-2440 for a full refund
The refund process will be initiated through Amazon or Walmart's return systems
If consumers decide to continue with the full refund process, they will be sen…
Designs Direct Recalls Cupcakes and Cashmere Brand Three-Light Floor Lamps, Due to Risk…
Designs Direct, d/b/a Designs Direct Creative Group, of Covington, Kentucky
Updated Oct 1About 4,200 units
When plugged in or switched on, the lamp cord or internal wiring can smoke, melt, spark, overheat or ignite, posing a risk of serious injur…
Hazard. When plugged in or switched on, the lamp cord or internal wiring can smoke, melt, spark, overheat or ignite, posing a risk of serious injury from fire and burn hazards.
What to do
Consumers should stop using the recalled lamp immediately, turn it off, and unplug it
Consumers will be asked to cut the cord and provide a photograph of the destroyed lamp, following the instructions at https://www.designsdirectllc.com/recalls/
Designs Direct will issue a full refund to consumer…
Xinan Home Recalls WinxMatrs Mattresses Due to Risk of Serious Injury or Death from Fire…
Xinan Home (China)
Updated Sep 24About 792 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattresses immediately and contact Xinan Home for a full refund
Consumers will be asked to destroy the mattress by writing in permanent marker “RECALLED,” on the top surface of the mattress and on the mattress label and send photos of the marked mattres…
Style Homeware Recalls Emerspring Mattresses Due to Risk of Serious Injury or Death from…
Sold Online At: Amazon.com from January 2026 through May 2026 for $226.
Updated Sep 24About 263 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do. Consumers should stop using the recalled mattresses immediately and contact Style Homeware to receive a free fitted cover to put over their mattress, which will bring the mattress into compliance with mandatory flammability standards.
Love To Dream Recalls Portable Sleep Machines Due to Risk of Injury from Fire and Burn…
Love To Dream, of Wilmington, Delaware
Updated Sep 24About 4,000 units
The lithium-ion battery in the recalled portable sleep machines can overheat if the charger is not compatible with the unit, posing a risk …
Hazard. The lithium-ion battery in the recalled portable sleep machines can overheat if the charger is not compatible with the unit, posing a risk of injury from fire and burn hazards.
What to do
Consumers should stop using the recalled sleep machines immediately and register at https://lovetodream.com/recall to receive a full refund
Consumers should have the model number and date code, which can be found on the side of the unit, when they register
Hyperfuels Recalls Methanol and Ethanol Fuel Containers Due to Risk of Serious Injury or…
Sold At: The Asylum Automotive Store in Houston, Texas and online at Hyperfuels.com and Amazon.com from May 2024 throug…
Updated Sep 24About 124 units
The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices…
Hazard. The recalled 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 flame jetting hazard. Furthermore, the methanol container is not child-resistant as required under the Poison Prevention Packaging Act, posing a risk of serious injury or death if the co…
What to do
Consumers should stop using the fuel containers immediately and contact Hyperfuels for a full refund or a replacement product
Consumers will be asked to destroy the fuel container by writing in permanent maker “RECALLED” on the product and to send a photo to [email protected]
5Color Recalls Children’s Bicycle Helmet and Pads Sets Due to Risk of Serious Injury or…
Sold Online At: Amazon.com in May 2026 for between $25 and $26.
Updated Sep 24About 324 units
The helmets in the recalled sets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impac…
Hazard. The helmets in the recalled sets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the impact attenuation, retention system, 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 5Color for a full refund of the set
Consumers will be asked to destroy the recalled helmet by cutting the straps and email a photo of the destroyed helmet to [email protected]
Consumers should then dispose of the recalled helmet
Toyworld168 Recalls Rainbow Mystery Squishy Bun Toys Due to Risk of Serious Injury or…
Toyworld168, of Orlando, Florida
Updated Sep 17About 276 units
The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitt…
Hazard. The squishy bun toys violate the mandatory safety standard for toys because the water beads inside the dumplings expand larger than permitted, posing a deadly ingestion hazard. If a water bead is ingested, it can pose ingestion, choking and intestinal obstruction hazards inside a child's body, resulting in severe discomfort, vomiting, dehydration and a risk of death to a child.
What to do
Consumers should stop using the squishy dumpling toys immediately and contact Toyworld168 for a full refund
Consumers will be asked to write "RECALLED" in permanent marker on the squeezy dumpling and its tan plastic container, throw the toy away and email a photo of the disposed toy to toyworld168…
Tongyang Cycling Recalls Basecamp Bicycle Helmets Due to Risk of Serious Injury or Death…
Sold Online At: Amazon.com from July 2024 through July 2026 for about $34.
Updated Sep 17About 315 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. In addition, the helmets have a button cell battery that does not bear the wa…
What to do
Consumers should stop using the helmets immediately and contact Tongyang Cycling for a full refund
Consumers will be asked to destroy the recalled helmet by cutting the straps and send a photo of the destroyed helmet to [email protected]
SHEIN Distribution Corporation Recalls Pull and Chew Montessori Teething Toys Due to Risk…
SHEIN Distribution, of Los Angeles, California
Updated Sep 17About 644 units
The recalled teething toys violate the mandatory safety standard for toys because the silicone strings are smaller and longer than permitte…
Hazard. The recalled teething toys violate the mandatory safety 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 a deadly choking hazard.
What to do
Consumers should stop using the recalled teething toys immediately, take them away from children, and contact SHEIN for a refund
Consumers will be asked to cut the teething toy’s silicone strings and send a photo of the destroyed toy to [email protected]
Regfear Recalls BedsPick Mattresses Due to Risk of Serious Injury or Death from Fire…
Sold Online At: Amazon.com from February 2025 through May 2026 for between $140 to $200.
Updated Sep 17About 818 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 mattresses immediately and contact Regfear for a full refund
Consumers will be asked to destroy the mattress, write in permanent marker “Recalled,” on the mattress’ top surface and email a photo of the destroyed mattress to [email protected].…
LANCHEZ Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
Ningbo Lanchez E-Commerce of China
Updated Sep 17329 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, which may encoura…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, which may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact LANCHEZ for a full refund
Consumers will be asked to unplug the pressure washer, destroy it by cutting the power cord in half and send a photo of the destroyed power washer, showing the model number, to service@lanch…
Victgoal Recalls Bicycle Helmets Due to Risk of Serious Injury or Death from Head Injury…
Dongguan Hongtu Sports Goods (China)
Updated Sep 10About 40 units
The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the retention system,…
Hazard. The recalled helmets violate the mandatory safety standard for bicycle helmets because the helmets do not comply with the retention system, 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 Victgoal for a full refund
Consumers will be asked to destroy the helmets by cutting the straps and then sending a photo of the destroyed product, showing the helmet’s production date to [email protected]
SQT Recalls Lontcs Busy Boards Due to Risk of Serious Injury from Lead Poisoning; Violate…
SQT LLC
Updated Sep 10About 1,835 units
The toys’ zipper contains levels of lead that exceed the standard set in the federal lead paint ban. Lead is toxic if ingested by young chi…
Hazard. The toys’ zipper contains levels of lead that exceed the standard set in the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health issues.
What to do
Consumers should stop using the busy boards immediately and contact SQT for a full refund
Consumers will be asked to destroy the toys by unscrewing its components, write in permanent marker “RECALLED” on the board, and send a photo of the destroyed toy to [email protected]
SHEIN Distribution Corporation Recalls Spiral Toys Due to Risk of Serious Injury or Death…
SHEIN Distribution of Los Angeles, California
Updated Sep 3About 963 units
The toys violate the small ball ban because they contain small balls and are intended for children under three years of age, posing a deadl…
Hazard. The toys violate the small ball ban because they contain small balls and are intended for children under three years of age, posing a deadly choking hazard.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact SHEIN for a full refund
Consumers will be asked to affirm they disposed of the entire toy, including the small balls
Nanjing Wu Hai Smart Home Appliance Store Recalls Alanca 6-Drawer Dressers Due to Risk of…
Sold Online At: Wayfair.com from April 2025 through June 2026 for between $206 and $240.
Updated Sep 3About 261 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standards as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall, place them in an area that children cannot access and contact Nanjing Wu Hai Smart Home for full refund
Consumers will be asked to write in permanent marker “RECALLED” on the top, front and side…
Steelite Pressure Washers Recalled Due to Risk of Serious Injury or Death from Shock and…
Longer 3D (China)
Updated Aug 27About 128 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of …
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing a risk of serious injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact Longer 3D for a full refund
Consumers will be asked to destroy the power washer by cutting the unplugged power cord in half and send a photo of the destroyed pressure washer to [email protected]
Pressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and…
YERYORK (China)
Updated Aug 27300 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious ri…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and an adequate-length power cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact YERYORK for a full refund
Consumers will be asked to unplug the pressure washer, destroy it by cutting the power cord in half, and send a photo of the destroyed power washer, showing the model number, to yeryorkrecal…
Little Loves & Co. Recalls Youth Clothing with Drawstrings Due to Risk of Serious Injury…
Little Loves &, of Olympia, Washington
Updated Aug 27About 590 units
The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazar…
Hazard. The drawstrings in the recalled clothing can get caught on objects and cause death or serious injury to children due to an entrapment hazard.
What to do
Consumers should take the recalled clothing away from children immediately and contact Little Loves & Co. for a full refund after return of the product
Consumers should contact Little Loves & Co. to receive a pre-paid shipping label to return the garment
Kmaier Recalls Infant Walkers Due to Risk of Serious Injury or Death from Fall Hazard…
Sold Online At: Target.com in June 2026 for between $62 and $70.
Updated Aug 27About 243 units
The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at …
Hazard. The recalled walkers violate the mandatory standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step, posing a deadly fall hazard.
What to do
Consumers should stop using the recalled walkers immediately and contact Kmaier for a full refund
Consumers will be asked to disassemble the walker; destroy it by cutting the walker’s fabric seat and writing in permanent marker “Recalled” on the top of the tray; and send a photo of the destr…
Excel Industries Recalls Accessory LED Light Kits Due to Risk of Serious Injury from Fire…
Excel Industries, of Hesston, Kansas
Updated Aug 27About 1,800 units
The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard.
Hazard. The light bars can overheat or produce flames, posing a risk of serious injury from a fire hazard.
What to do
Consumers should stop using the accessory LED Light Kits immediately and contact their point-of-sale dealers to receive a refund upon return of the light kit
Light kits installed on mowers can be removed either at the local dealer or at the consumer’s residence
AudioLineOut Recalls Studio Six Headphone Amplifiers Due to Risk of Serious Injury or…
Sold At: Independent stereo stores nationwide and online at aloaudio.com from December 2014 through December 2022 for a…
Updated Aug 27About 90 units
When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or d…
Hazard. When the amplifiers are used with aftermarket metal base tubes, the bare metal can become electrified, posing a risk of serious injury or death from electrocution.
What to do
Consumers should stop using the recalled amplifiers immediately and contact AudioLineOut for a free repair
Consumers should contact AudioLineOut at [email protected] for a prepaid shipping label to ship back the product for repair
Alternatively, consumers can utilize the originally supplied va…
Koorlian Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard…
Dreams Bedding Technology PTE. (Singapore)
Updated Aug 20About 251 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do. Consumers should stop using the recalled mattress immediately and contact Dreams Bedding Technology to receive a free cover to put over their mattress to bring it into compliance with the mandatory flammability standards.
CCM Hockey U.S. Recalls FMHVR Hybrid Visors and ACCHVR Replacement Visor Accessories Due…
CCM Hockey U.S., of Maple Grove, Illinois
Updated Aug 20About 12,957 units
The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact haz…
Hazard. The recalled hockey visors and replacement visor accessories can crack upon impact, posing a risk of injury due to laceration or impact hazards.
What to do
Consumers should stop using the recalled visors and visor accessories immediately and return the products to the nearest participating retailer for a free replacement
Consumers can choose from the FV1 full visor, FM780 combo cage, or FM580 combo cage
Sunnyside Corporation Recalls 1-K Kerosene Heater and Appliance Fuel Containers Due to…
Amazon.com online and Do-It Best Hardware Stores from May 2026 through July 2026 for about $13.
Updated Aug 13About 960 units
The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mit…
Hazard. The pre-filled fuel containers violate the mandatory safety standards of the Portable Fuel Container Safety Act because they lack flame mitigation devices, posing a deadly risk of flash fire and burn hazard.
What to do
Consumers should stop using the recalled fuel bottles immediately, place them out of reach of children, and contact Sunnyside for a full refund
Consumers will be asked to write "RECALLED" with permanent marker on the bottle; and submit a photo of it to [email protected]
SUGIFT Recalls SUGIFT Pressure Washers Due to Serious Risk of Injury or Death from Shock…
SUGIFT, of Albany, NY
Updated Aug 1313 units
The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encoura…
Hazard. The recalled pressure washers lack an integral ground-fault circuit-interrupter (GFCI) and, because the power cord is short, it may encourage use of an extension cord, posing serious risks of injury or death from shock and electrocution hazards.
What to do
Consumers should stop using the recalled pressure washers immediately and contact SUGIFT for a full refund
Consumers will be asked to destroy the pressure washer by cutting the power cord in half (the product should be completely turned off and unplugged from power outlet) and send a photo of the …
Shengsen Prank Sound Makers Recalled Due to Risk of Serious Injury or Death from Battery…
Online at Amazon.com from April 2024 through April 2026 for about $8.
Updated Aug 13About 667 units
The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithi…
Hazard. The recalled sound maker violates the mandatory safety standard for consumer products with button cell and coin batteries because the lithium coin batteries can be accessed easily by children, posing an ingestion hazard. Additionally, the packaging and product do not have the warnings required under Reese's Law. When button cell or coin batteries are swallowed, the ingested batteries can cause se…
What to do
Consumers should stop using the sound maker immediately and contact Shengsen Toys for a full refund
Consumers will be asked to properly dispose of the sound maker into the trash and send a photo of the disposed product to [email protected]
Note: Button cell and coin batteries are hazardous
Ritchey Design Recalls Carbon Bicycle Forks Due to Risk of Serious Injury or Death from…
Ritchey Design, of Reno, Nevada
Updated Aug 13About 775 units
The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's…
Hazard. The alloy insert located in the front crown hole of the carbon fork can come loose, causing an accessory to fall off and land on the bike's front wheel, posing a risk of serious injury or death from a fall and crash hazard.
What to do
Consumers are asked to stop using the bicycles equipped with the recalled fork immediately
Please inspect the front crown hole for any attached racks or accessories
The threaded hole located above the front wheel should be closed immediately
Consumers should register at https://ritcheylogic.com/…
Mattresses Recalled Due to Risk of Serious Injury or Death from Fire Hazard; Violate…
Online at Amazon.com from November 2025 through March 2026 for between $120 and $140.
Updated Aug 13About 774 units
The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
Hazard. The recalled mattresses violate the mandatory flammability standard for mattresses, posing a risk of serious injury or death from fire.
What to do
Consumers should stop using the recalled mattresses immediately and contact Qabefy for a full refund
Consumers will be asked to destroy the mattress, by writing in permanent marker "Recalled," their name and the current date on the mattress's top surface, and to email a photo of the destroyed matt…
Fastbuy Recalls Zimtown Portable Gas and Fuel Cans Due to Risk of Serious Injury or Death…
Online at Walmart.com and Zimtown.com from May 2026 through July 2026 for between $32 and $63.
Updated Aug 13About 200 units
The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child…
Hazard. The fuel containers violate the requirement for closures under the Children's Gasoline Burn Prevention Act because the closure is not child-resistant, posing a risk of burns and poisoning to children.
What to do
Consumers should stop using the gas and fuel containers immediately and contact Fastbuy for a full refund
Consumers should disassemble the spout, cut it into pieces with scissors and dispose of it separately from the container
Consumers will be asked to write "RECALLED" on the container and submi…
CuberShop Magnetic Speed Cubes Recalled Due to Risk of Serious Injury or Death from…
SKY CUBE HK (China)
Updated Aug 13About 132 units
The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing…
Hazard. The recalled magnetic cubes violate the mandatory standard for toys because the cubes were packaged with loose high-powered magnets, posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other, or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestin…
What to do
Consumers should take the recalled loose magnets away from children, stop using them immediately, and contact SKY CUBE HK for information on how to receive a $5 refund
Consumers will be asked to throw away the magnets and email a photo of the disposed magnets to [email protected]
The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". How…
Hazard. The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020117
Steris
Updated Sep 21106758 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
Hayward Industries Recalls Universal Pool Heaters Due to Risk of Serious Injury or Death…
Hayward Industries, of Charlotte, North Carolina
Updated Sep 17About 4,600 units
This recall involves Hayward-branded HDFS400 Universal-HC Series pool heaters. The 400,000 BTU dual-fuel gas heaters are brown with black atop and measure 21 inches long, 28 inches wide and 31 inches high. The pool heaters have a digital display control panel at the top and a molded base with integrated tie-down connections. The heater’s name plate is below the vent with the word “Hayward” appearing at the bottom of the name plate and the model number “HDFS400” appears at the top of the name plate.
What to do. Consumers should stop using the pool heater immediately and contact Hayward Industries to schedule a free in-home inspection and repair by a qualified technician.
Friedrich Air Conditioning Recalls KÜHL Window Air Conditioners Due to Risk of Serious…
Friedrich Air Conditioning, of San Antonio, Texas
Updated Sep 17About 2,000 units
This recall involves KÜHL Q and KÜHL S Window Air Conditioners. The products have a gray front and a black air discharge grille and have the name Friedrich and the Friedrich logo in the lower left corner of the unit. The Kühl Q front control panel is located on the top left corner of the unit, and the Kühl S front control panel is located on the right side of the unit below the discharge grille. The models are KCVQ08B10A, KHVQ10B11A, KCVS08B10A, KCVS12B10A, KCVS12B30A and KCVS16B30A. The model and serial number are located inside the air conditioners. Only some serial numbers below have m…
What to do
Consumers should stop using the recalled air conditioners immediately and visit www.friedrich.com/product-recall to receive information on how to determine if their unit is covered by the recall
Consumers should have the air conditioner’s serial number, which can be found on the inside of the un…
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working a…
Hazard. Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO…
Medtronic Neuromodulation
Updated Sep 856,331 (US); 40,211 (OUS) units
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working a…
Hazard. Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE…
Beckman Coulter
Updated Sep 2146 US, 170 OUS units
Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configu…
Hazard. Beckman Coulter has identified a software issue affecting DxC 500 AU Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system defau…
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522…
Beckman Coulter
Updated Sep 2146 US, 170 OUS units
Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configura…
Hazard. Beckman Coulter has identified a software issue affecting DxC 500i Clinical Analyzers when testing plasma samples. Following user configuration of a Clinical Chemistry test to use units different from the system default, a subsequent configuration change and activation of the draft configuration in the System Configuration page may cause the analyzer to revert the test units to the system default…
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
POLYMED / POLYMED CANCER DIAGNOSTIC PRODUCTS
Updated Aug 25448400 units
During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup …
Hazard. During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…
Boston Scientific
Updated Aug 24262,686 units
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact m…
Hazard. Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes…
ICU Medical
Updated Aug 20185,688 units units
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of th…
Hazard. Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction…
Percussionaire
Updated Aug 18228,596 units
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction…
Percussionaire
Updated Aug 18228,277 units
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number…
American Nitrile Operations
Updated Aug 1499,724,000 units
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient…
Hazard. Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient…
Hazard. Gloves may exhibit defects such as tears, missing fingers, and debris. Use of defective gloves may lead to healthcare personnel and patient exposure to infectious pathogens leading to infection or cross-contamination, or exposure to chemical agents leading to irritation or systemic toxicities.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylen…
Hazard. Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.
Vanderhall North America Recalls Brawley GTS Electric Recreational Off Highway Vehicles…
Vanderhall North America, of Provo, Utah
Updated Aug 6About 210 units
The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of ser…
Hazard. The recalled recreational off highway vehicle can maintain speed or accelerate when the accelerator pedal is released, posing a risk of serious injury or death from a crash hazard.
What to do
Consumers should stop using their vehicles immediately and contact Vanderhall North America for instructions on how to update their vehicles to firmware version 7.1.0 through the Vanderhall customer mobile app
The updated software was released on April 15, 2026, and can be identified by Vanderhall…
Syera Projecting Finger Light Toys Recalled Due to Risk of Serious Injury from Battery…
Online at Temu.com from December 2025 through April 2026 for between $8 and $16.
Updated Aug 6About 184 units
The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily…
Hazard. The recalled LED finger lights violate the mandatory safety standard for toys because they contain button cell batteries that can be easily accessed by children. If button cell or coin batteries are swallowed, the ingested batteries can cause serious injuries, including internal chemical burns, and death.
What to do
Consumers should stop using the recalled toys immediately, take them away from children and contact Syera for a full refund
Consumers will be asked to remove and properly dispose of the finger lights into the trash and send a photo of the disposed product to [email protected]
Magnetic Fidget Sliders Recalled Due to Risk of Serious Injury or Death from Magnet…
Huoshan County Haozhou E-commerce, doing business as PIXLABBY (China)
Updated Aug 6860 units
The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestio…
Hazard. The magnetic fidget sliders violate the mandatory standard for toys because they can liberate loose high-powered magnets posing an ingestion hazard to children. When high-powered magnets are swallowed, the ingested magnets can attract each other or other metal objects and become lodged in the digestive system. This can result in perforations, twisting, and/or blockage of the intestines, blood poi…
What to do
Consumers should take the fidget sliders away from children, stop using them immediately and contact PIXLABBY for a full refund
Consumers will be asked to throw away the fidget sliders and submit a photo of the disposed toys to [email protected] to receive a refund
Fitueyes Recalls Laziza Dressers Due to Risk of Serious Injury or Death from Tip-Over and…
Fitueyes, of City of Industry, California
Updated Aug 6About 150 units
The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of…
Hazard. The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in risks of serious injuries or death to children. The dressers violate the mandatory safety standard as required by the STURDY Act.
What to do
Consumers should stop using the recalled dressers immediately if they are not anchored to the wall and place them in an area that children cannot access
Contact Fitueyes for a full refund
Consumers will be asked to write the word "recalled" on the top and all sides of the dresser with a permanent…
OCOOPA Direct Recalls 1.5 Million Rechargeable Hand Warmers Due to Risk of Serious Injury…
OCOOPA Direct (China)
Updated Jul 30About 1.5 million units
The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn h…
Hazard. The lithium-ion battery in the recalled hand warmers can overheat and ignite, posing a risk of serious injury or death from fire and burn hazards.
What to do
Consumers should stop using the recalled hand warmers immediately and contact OCOOPA Direct for a full refund in the form of an OCOOPA gift card or the original form of payment
Consumers will be asked to write in permanent marker "RECALLED" on the hand warmer and submit a photo showing that markin…
Mangohood Direct Kids Kitchen Standing Towers Recalled Due to Risk of Serious Injury and…
Mangohood Direct (China)
Updated Jul 30105 units
The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sid…
Hazard. The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the front and back sides, posing a risk of serious injury and death due to tip over, fall and entrapment hazards.
What to do
Consumers should stop using the recalled tower stools immediately and store them away from children until repaired
Contact Hangzhou Xinyanchuangxin for repair parts, which include stabilizing feet and installation instructions
The firm will mail the repair parts directly to consumers free of char…
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may resul…
Hazard. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may resul…
Hazard. Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of…
Hazard. Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN)…
Johnson & Johnson Surgical Vision
Updated Jul 31111,478 units
Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resista…
Hazard. Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma or descemet's membrane detachment.
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13…
GE Medical Systems Information Technologies
Updated Jul 3029,570 (23,632 US; 5,938 OUS) units
Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition …
Hazard. Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events.
Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely eleva…
Hazard. Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.
Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx…
ARGATROBAN
Updated Oct 131944 vials units
Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material…
Hazard. Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
Hampton Bay Halwin 52-Inch Ceiling Fans Recalled Due to Impact and Injury Hazards…
Youngo, of Huizhou, China
Updated Aug 13About 9,460 units
The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.
Hazard. The fan blades can separate from the fan motor flywheel, posing impact and injury hazards to consumers.
What to do
Consumers should stop using the recalled ceiling fans immediately and contact Youngo for either a full refund by ACH payment or store credit in the form of a Home Depot gift card
To receive either option, consumers should contact Youngo with proof of purchase or a photograph of the serial number (…
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular acc…
Hazard. Ultrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which may be unavailable outside of the hospital (ambulances/aircraft/field); 2) At connection between transducer USB cable to tablet/phone, there may be an unstable connection/may disconnect disrupting function. May cause diagnosis/treatment delay.
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020116
Steris
Updated Sep 2111806 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
V*Home, Model Number: PRT-01444-000, Package PN:PRT-01445-000. used for ventilatory…
Ventec Life Systems
Updated Sep 1725,112 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
V+Pro Model Number: PRT-01185-000, Package PN:PRT-01198-000; Model Number: PRT-01185-001…
Ventec Life Systems
Updated Sep 1739,568 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000…
Ventec Life Systems
Updated Sep 1730,120 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline…
Medline Industries, LP
Updated Sep 236199 kits units
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound e…
Hazard. Compression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration and irrigation, formation of scar tissue, and infection.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA
Updated Aug 3129,737 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama…
Mindray DS USA
Updated Aug 3111,831 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA
Updated Aug 3144,651 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Steris
Updated Aug 311185 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Steris
Updated Aug 312205 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA
Updated Aug 3139,891 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 2-Line, Red…
ASP Global
Updated Aug 2455050 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-Line, Blue…
ASP Global
Updated Aug 2453040 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum…
ASP Global
Updated Aug 2410060 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-Line, Blue…
ASP Global
Updated Aug 2465640 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-Line, White…
ASP Global
Updated Aug 2445960 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red…
ASP Global
Updated Aug 2436680 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-Line, White…
ASP Global
Updated Aug 2434550 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Rollator, Bariatric, Basic Steel, Burgundy, mechanical walker with four legs and a metal…
Medline Industries, LP
Updated Aug 141824 units units
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnec…
Hazard. The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…
Cranberry Chicken Salad Wedge 4.5 oz package in Wedge plastic and clear container with a…
FRESHPOINT CENTRAL FLORIDA
Updated Sep 41093 units units
The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, i…
Hazard. The chicken salad sandwich has an improperly declared allergen (egg). While egg is included in the ingredients list on the package label, it is not included in the allergen Contains statement.
Clorox Puerto Rico Recalls 6 Million Scented Mistolin and Lestoil Multi-Purpose Cleaners…
Clorox Manufacturing of Puerto Ri, Puerto Ri
Updated Sep 3About 6.3 million units
The recalled products may contain bacteria, including Pseudomonas aeruginosa, which is an environmental organism found widely in soil and w…
Hazard. The recalled products may contain bacteria, including Pseudomonas aeruginosa, which is an environmental organism found widely in soil and water. People with weakened immune systems or external medical devices who are exposed to Pseudomonas aeruginosa face a risk of serious infection that may require medical treatment. The bacteria can enter the body if inhaled, through the eyes, or through a brea…
What to do
Consumers should stop using the recalled cleaners immediately
Consumers will be asked to register at https://mistolinrecall.expertinquiry.com/ and submit a picture of the 12-digit UPC code printed on the label and a picture of the date code printed on the side of the bottle and dispose of the prod…
Audio Partnership Recalls Cambridge Audio Yoyo (M) Portable Bluetooth Speakers Due to…
Audio Partnership (England)
Updated Sep 3About 714 units
The lithium-ion batteries in the Cambridge Audio Yoyo (M) Portable Bluetooth Speaker can overheat, posing a fire hazard.
Hazard. The lithium-ion batteries in the Cambridge Audio Yoyo (M) Portable Bluetooth Speaker can overheat, posing a fire hazard.
What to do
Consumers should stop using the recalled speakers immediately, disconnect them from the power supply, stop charging them, store them away from combustible materials and contact Audio Partnership for a full cash refund of $218 or Cambridge Audio online store voucher of $350
Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE…
Medline Industries, LP
Updated Aug 11489 kits units
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…
Medline Industries, LP
Updated Aug 11447 kits units
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental cond…
Hazard. The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Baxter Healthcare
Updated Aug 1114601 units units
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volu…
Hazard. A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU…
Cardinal Health 200
Updated Aug 1017503 kits units
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contamina…
Hazard. The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
Fresenius Medical Care Renal Therapies Group
Updated Aug 1018,600 units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
Fresenius Medical Care Renal Therapies Group
Updated Aug 1062,544 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that…
Lutronic
Updated Aug 61065 units
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potential…
Hazard. Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBCo…
Hazard. Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC pre-installed with Microsoft SQL Server 2022 Express. When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started. This causes a delay in obtaining patient re…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…
Howmedica Osteonics
Updated Jul 3012,156 US units
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Produc…
Hazard. Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and infla…
BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…
Bard Access Systems
Updated Jul 3080,200 units
After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or…
Hazard. After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases, users may experience difficulty/inability to remove obturator, due to it locking to the needle hub, due to out-of-tolerance dimensions and IFU unclarity, which may result in new needle placement, which may result in delayed therapy
StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.
Nova Biomedical
Updated Jul 2920,616 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.
Nova Biomedical
Updated Jul 2910,941 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl…
OurPharma
Updated Sep 31,610 bags units
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2…
Hazard. Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instan…
Hazard. Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quickly than expected during use. Patients are at some risk for injury if a significant fall/drop were to occur due to this issue.
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Steris
Updated Aug 31233 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris
Updated Aug 31217 units
Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor …
Hazard. Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage fr…
Hazard. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal…
Medline Industries, LP
Updated Aug 14835 units units
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnec…
Hazard. The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach from the rollator. If the front wheels become loose or detach during use, there is risk of severe adverse events. The immediate consequences could include falls resulting in head tr…
Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potenti…
Hazard. Subrecall of a kitted device from SafeGuard Medical due to internal testing identified an issue affecting the device's sterile pad, potentially causing the sterile pad to degrade over time. The degradation may cause remnants of the nonwoven pad material to dislodge on the wound or in close proximity to the wound.
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory…
Ventec Life Systems
Updated Sep 174,369 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC+Pro Model Number: PRT-00900-001, Package PN:PRT-00973-000. used for ventilatory…
Ventec Life Systems
Updated Sep 171,534 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN Model Number: PRT-01100-000, Package PN:PRT-01126-000. used for ventilatory support.
Ventec Life Systems
Updated Sep 171,532 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VCSN+Pro Model Number: PRT-01184-000, Package PN:PRT-01172-000. used for ventilatory…
Ventec Life Systems
Updated Sep 174,368 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 162547 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270
Boston Scientific Cork
Updated Sep 161912 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 163145 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161442 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161212 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161135 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 161292 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 161349 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 163284 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 168542 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 167945 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of p…
Hazard. Silk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product design, that if discovered prior to use may cause surgical delay. If used, fluid could cause reduced suture tensile strength or knot security, tissue irritation/inflammatory tissue response, and treatment failure, including wound dehiscence/bleeding.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name…
Medline Industries, LP
Updated Sep 21834 kits units
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation …
Hazard. Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA
Updated Aug 311,699 units units
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and sy…
Hazard. Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result in delays or ending procedures.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 18" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 242750 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 241100 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 241740 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…
Philips North America
Updated Aug 211447 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…
Philips North America
Updated Aug 212038 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained…
Radiometer Medical ApS
Updated Aug 185395 units
In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, i…
Hazard. In vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including whole blood samples no longer suitable for testing FHbF and ctBil, 2) Reportable ranges for some parameters, 3) Analyzer configuration, and 4) limitations and warnings.
MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF…
Microgenics
Updated Aug 171366 units
Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Para…
Hazard. Vial-to-vial variability in MAS¿ Omni"IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, Lot OPRO29061A results in low Parathyroid Hormone (PTH) recovery, which may lead to a delay in reporting patient PTH results.
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid …
Hazard. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand …
Hazard. Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Falling stand may cause impact or crushing injuries, particularly to the feet, legs, hands or arms of the operator or nearby persons.
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary…
American Contract Systems
Updated Aug 101,804 kits total units
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant…
Hazard. Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection…
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary…
American Contract Systems
Updated Aug 101,804 kits total units
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant…
Hazard. Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection…
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contamina…
Hazard. The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Fresenius Medical Care Renal Therapies Group
Updated Aug 106,624 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving…
GE Healthcare
Updated Jul 311856 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage…
GE Healthcare
Updated Jul 311443 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Enterprise Archive V8, software product for receiving, archiving, and sending electronic…
GE Healthcare
Updated Jul 311298 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
Nova Biomedical
Updated Jul 291,858 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.
Nova Biomedical
Updated Jul 298,939 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Windstone Medical Packaging
Updated Jul 293,260 kits units
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-P…
Hazard. The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.
Nova Biomedical
Updated Jul 292,044 units units
A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermitten…
Hazard. A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when a new barcode is scanned, resulting in the prior barcode information remaining displayed on the screen for the current tes…
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net…
Sun Noodle
Updated Aug 4140 packages units
Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle packag…
Hazard. Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
HexaVue Focus Integration System, a single, all-in-one system that handles operating room…
Steris
Updated Sep 2358 systems units
A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appeari…
Hazard. A software issue may result in unintended mismatch of patient information on manually printed images. Incorrect patient information appearing on printed images could create a documentation discrepancy or incorrect association of clinical images with a patient record.
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following…
Beckman Coulter
Updated Sep 21336 units units
Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. R…
Hazard. Rotors have been found with a non-conforming microstructure, which may result in some rotors breaking into two or more pieces during use. Rotors that break into multiple pieces during use may result in significant damage to materials (i.e., samples) being processed in the centrifuge and to the centrifuge instrument.
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following…
Beckman Coulter
Updated Sep 2192 units units
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate)…
Hazard. Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to bi…
RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115
Steris
Updated Sep 21374 units units
If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess va…
Hazard. If the vented cap becomes blocked, gas may accumulate and the bottle may swell due to increased internal pressure. In some cases, excess vapor or liquid chemistry may escape from the bottle when the cap is twisted during opening, which could result in user exposure if required personal protective equipment (PPE) is not properly used. Such exposure may result in injury to the user or others in clo…
VC Model Number: PRT-01098-000, Package PN:PRT-01125-000. used for ventilatory support.
Ventec Life Systems
Updated Sep 17930 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC+Pro (Japan) Model Number: PRT-00900-100, Package PN:PRT-00973-100. used for…
Ventec Life Systems
Updated Sep 17606 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for…
Ventec Life Systems
Updated Sep 17325 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory…
Ventec Life Systems
Updated Sep 17180 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory…
Ventec Life Systems
Updated Sep 17100 units units
Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interr…
Hazard. Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra…
Cook
Updated Sep 1697 units units
The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate to…
Hazard. The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
Howmedica Osteonics
Updated Sep 16359 trays units
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16609 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16206 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16632 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16860 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16926 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480
Boston Scientific Cork
Updated Sep 1645 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1676 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16112 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470
Boston Scientific Cork
Updated Sep 16382 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16156 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16598 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1639 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16378 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
Philips North America
Updated Sep 16174 units
Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastruc…
Hazard. Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX).
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16486 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16902 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16459 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 16126 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16228 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16384 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16550 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 1686 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16357 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 16689 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16658 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16748 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Boston Scientific Cork
Updated Sep 16358 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Boston Scientific Cork
Updated Sep 16381 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number…
Boston Scientific Cork
Updated Sep 16432 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number…
Boston Scientific Cork
Updated Sep 16620 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number…
Boston Scientific Cork
Updated Sep 1642 units
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segme…
Hazard. The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When bl…
Hazard. Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time may lead to a small amount of residual moisture remaining after sterilization.
CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to…
Hazard. CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting insulin. Instead, the calculator conti…
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Boston Scientific
Updated Sep 10403 units
Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature assoc…
Hazard. Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
AVID Medical
Updated Sep 856 kits units
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit…
Hazard. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Halyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH30.
AVID Medical
Updated Sep 880 kits units
A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit…
Hazard. A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number…
Nihon Kohden America
Updated Sep 8808 units
Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of th…
Hazard. Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics
Updated Sep 4321 units units
In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while …
Hazard. In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600…
Medtronic MiniMed
Updated Sep 2623 units
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 …
Hazard. A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled time to remind users to take their long…
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and ma…
Hazard. Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiologi…
Hazard. Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
Philips North America
Updated Aug 281 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T)…
Philips North America
Updated Aug 2891 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341…
Philips North America
Updated Aug 28216 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software…
Philips North America
Updated Aug 28107 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3…
Philips North America
Updated Aug 28243 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 1…
Hazard. A navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch MacBook Pro battery, subject to an Apple battery recall, that may overheat and pose a fire safety risk.
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106…
Philips North America
Updated Aug 28340 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108…
Philips North America
Updated Aug 28422 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192…
Philips North America
Updated Aug 286 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11…
Philips North America
Updated Aug 285 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software…
Philips North America
Updated Aug 28131 units
When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data…
Hazard. When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is used in conjunction with third-party software for tractography (e.g. for mapping nerve fiber pathways in the brain), the software will not be able to correctly process the DTI data for reconstruction.
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patie…
Hazard. Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10)…
ASP Global
Updated Aug 2450 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24360 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 2480 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Olympus of the Americas
Updated Aug 2450 units units
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters…
Hazard. There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24820 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24410 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24180 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 24850 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Olympus of the Americas
Updated Aug 2472 units units
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters…
Hazard. There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 1 LINE (10) Model/Catalog…
ASP Global
Updated Aug 2430 units
Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf li…
Hazard. Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is 5 years.
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X…
PHILIPS MEDICAL SYSTEMS
Updated Aug 21539 units
Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thick…
Hazard. Software issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or unintended system motion.
iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm)…
SI-BONE
Updated Aug 21100 units units
The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance can…
Hazard. The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR…
Philips North America
Updated Aug 21965 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers…
Philips North America
Updated Aug 21387 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…
Philips North America
Updated Aug 21922 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T)…
Philips North America
Updated Aug 2191 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Philips North America
Updated Aug 2115 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…
Philips North America
Updated Aug 2137 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S)…
Philips North America
Updated Aug 21596 units
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such th…
Hazard. A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wo…
Hazard. Robotic system square drive failed to meet design specifications potentially resulting in pin becoming stuck in square driver or the pin wobbling during drilling.
Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed)…
Hazard. Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection for moisture exposure, slow battery char…
EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number…
Bard Peripheral Vascular
Updated Aug 2099 units
Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH0…
Hazard. Breast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code HH01-00020009) , 2) Pressure sensor (code E01-0054000E), which prompts the user to restart and re-calibrate; errors may lead to interruption or prolongation of the biopsy procedure, or the need for additional tissue sampling or repeat biopsy.
Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty i…
Hazard. Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20…
Hazard. Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF…
Stryker Sustainability Solutions
Updated Aug 1810 units
Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if use…
Hazard. Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.
Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrica…
Hazard. Stimulator device contains a defective printed circuit board assembly (PCBA) that may cause the device to unintentionally deliver electrical stimulation to the patient, or allow an unintended electrical current to reach the patient.
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code…
Philips North America
Updated Aug 1862 units
The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast t…
Hazard. The Bolus tracking scan application may crash with a system error message. Bolus Tracker shots may continue to occur even if the contrast threshold is reached. This may result in the patient receiving additional radiation.
Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems be…
Hazard. Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure, awareness during anesthesia, oversedation
CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression…
Wright Medical Technology
Updated Aug 1834 units
Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on …
Hazard. Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would prevent a secure rigid engagement with the plate's internal threads, which may lead to surgery prolongation to retrieve another device, or alternative surgery method if no replacement device is readily available.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses…
Baxter Healthcare
Updated Aug 18169 units units
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align …
Hazard. There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality…
Hazard. A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of i…
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…
Medtronic Sofamor Danek USA
Updated Aug 1220 units
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility req…
Hazard. Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid …
Hazard. The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak…
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with…
Medtronic Sofamor Danek USA
Updated Aug 1218 units
Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility req…
Hazard. Medtronic identified through donor record review that the donor for Medtronic batch A62881 did not meet all Medtronic donor eligibility requirements related to the presence of microbial organisms. While the batch passed finished product sterility testing Medtronic is retrieving any unused product manufactured from the donor tissue. Donor bone tissue tested positive for Clostridium butyricum and w…
Computed Tomography X-ray System, Model: uCT ATLAS with software
Shanghai United Imaging Healthcare
Updated Aug 1111 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 780 with software
Shanghai United Imaging Healthcare
Updated Aug 1114 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with…
Shanghai United Imaging Healthcare
Updated Aug 116 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 550 with software
Shanghai United Imaging Healthcare
Updated Aug 1123 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare
Updated Aug 114 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT 760 with software
Shanghai United Imaging Healthcare
Updated Aug 111 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Shanghai United Imaging Healthcare
Updated Aug 1153 units
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and mul…
Hazard. Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Baxter Healthcare
Updated Aug 114 units units
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volu…
Hazard. A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging…
Hazard. Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lead to infection.
Medline Convenience Kits: 1) MAJOR PACK, Catalog Number: DYNJ81325A
Medline Industries, LP
Updated Aug 10128 kits units
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on t…
Hazard. Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin lev…
Hazard. The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on t…
Hazard. Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards associated include cut injury/abrasion and infection.
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
Fresenius Medical Care Renal Therapies Group
Updated Aug 10120 units units
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during tre…
Hazard. Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Philips Ultrasound
Updated Aug 7219 units units
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causi…
Hazard. Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect …
Hazard. Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance CT 64 systems that could affect the performance of the equipment.
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano
Updated Aug 619 systems units
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or tr…
Hazard. Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000…
IMRIS Imaging
Updated Aug 613 units units
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitionin…
Hazard. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned…
IMRIS Imaging
Updated Aug 66 units units
The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitionin…
Hazard. The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…
Boston Scientific
Updated Aug 6N/A units
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors…
Hazard. There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display thi…
Hazard. When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly, which may lead users to incorrectly omit the bolus during treatment and deliver the prescribed dose to the wrong tissue depth.
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A…
Baxter Healthcare
Updated Aug 32 units
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices ret…
Hazard. Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
Centricity PACS Server V7, intended for managing digital medical images and associated…
GE Healthcare
Updated Jul 31116 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734F
Medline Industries, LP
Updated Jul 31459 units
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Workflow Core Services V8, intended to provide set of services for storage and retrieval…
GE Healthcare
Updated Jul 31169 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and…
GE Healthcare
Updated Jul 31250 systems units
Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. …
Hazard. Under certain conditions historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record, which could lead to misdiagnosis or a delay in patient care.
Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925A
Medline Industries, LP
Updated Jul 31341 units
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may…
Hazard. Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field or patient infection if product is used.
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda
Updated Jul 30140 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Et Control, Software option for anesthesia gas machine to achieve and maintain targeted…
Datex-Ohmeda
Updated Jul 30410 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000
Datex-Ohmeda
Updated Jul 307 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda
Updated Jul 30475 units units
Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alt…
Hazard. Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition to Alternate O2 control. In Alternate O2 control, the system delivers 100% O2 to the breathing system enabling continued controlled or manual ventilation and initiates audible and visual alarms. When this issue occurs, anesthetic agent delivery will be interrupted and requires clinician int…
