Archive
608 recalls were announced in December 2022.
Of the 608 recalls this month scored against our rubric, 1% are Critical, 16% are Severe.
Which agencies issued them
Hendrickson is recalling Vantraax trailer suspension assemblies because a loose retaining clip may damage brake pads or tires, increasing crash risk.
ZLINE is recalling about 28,000 gas ranges because the oven can emit dangerous levels of carbon monoxide while in use, posing a serious risk of injury or death. The firm has received 44 reports of carbon monoxide emission, including three reports of consumers seeking medical attention.
Surf 9 is recalling Body Glove Tandem and ULI inflatable paddle boards sold at Costco because glue can separate at the seams, causing unexpected deflation and posing a drowning hazard. Three deflation reports have been received with no injuries yet reported.
Yamaha is recalling about 500 Viking Off-Road Side-by-Side vehicles because improper installation of parking brake retaining bolts could cause the brake to fail, allowing the parked vehicle to move unintentionally and potentially crash.
Indian is recalling 2022 Chief and related motorcycles because the kickstand may not properly retract while riding. A failure to retract increases the risk of a crash.
Volkswagen is recalling certain 2023 ID.4 rear-wheel drive vehicles because the 12-volt battery charging cable may wear and cause a short circuit, risking vehicle fire and power loss. Dealers will inspect and repair or replace the cable at no charge.
Joybuy Express is recalling Marainbow Portable Infant Safe Seats because incorrect installation labels and design flaws prevent proper installation, increasing injury risk in crashes.
Utopia Foods Inc. is recalling Utopia brand Enoki Mushrooms (200g) due to potential Listeria monocytogenes contamination. Consumers should not consume this product.
Gamesa Arcoiris Marshmallow Cookies with best-before date 28MAR23 are being recalled due to potential Salmonella contamination. Approximately 19,764 boxes were distributed in Texas and California.
Natus Medical is recalling 249 Cranial Access Kits distributed nationwide. The sterile surgical drape liners are difficult to remove without damage, potentially rendering the kits unusable for neurosurgical procedures.
Lamaze Chill Teether teething rings are being recalled due to potential microbial growth in the internal fluid. This poses an infection risk, particularly for children with weakened immune systems.
Icotec Ag is recalling six VADER Pedicle System Torque Wrench devices due to a calibration error where the torque limiting function was found to be out of specification, delivering 4 Nm instead of the specified 12 Nm.
GE Medical Systems is recalling Vivid i ultrasound systems because batteries not replaced every two years may fail, emit smoke, or catch fire. About 7,931 units were distributed worldwide.
It'll Be Pizza is recalling 24 oz frozen pizza dough distributed in five northeastern states due to possible contamination with foreign debris from packaging. Consumers should not consume affected products.
After installing the IAS tool, Centricity PACS-IW Universal Viewer version 5.0 may hide some medical imaging studies without notification. Accessing hidden studies requires GE Healthcare assistance and may cause diagnostic delays.
The InPen Diabetes Management App may crash on certain Android versions, preventing dose reminders and potentially delaying insulin therapy. This could affect users of the diabetes management system.
NuVasive's X-CORE 2 spinal implants may not disengage properly from the vertebral replacement device, potentially requiring revision surgery. About 2,031 devices worldwide are affected.
HeartWare Model 1102 cardiac assist devices are being recalled because the driveline cover may harden over time, preventing timely access to the critical driveline connector during urgent clinical situations.
Kerry Inc is recalling flour-based breading products because the product contains egg allergen that is not declared on the label. The product was distributed to two customers in Mississippi.
HeartWare HVAD Pump Kit driveline covers may harden over time, making them difficult to remove for urgent servicing. In an emergency scenario requiring driveline access, delays could harm patients.
Sun Pharmaceutical is recalling three lots of Oxcarbazepine 600mg tablets due to the presence of foreign substances. The affected medication was distributed nationwide.
Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.
Baxter Healthcare is recalling Revaclear 400 dialyzers because polyurethane displacement may cause blood leaks during dialysis treatment. Approximately 1.14 million units are affected worldwide.
Baxter is recalling approximately 14 million units of Revaclear 300 dialyzers worldwide due to polyurethane displacement that could cause blood leaks. No injuries have been reported.
GE Vivid S6 ultrasound systems are recalled for a potential battery hazard. If not replaced at the recommended 2-year interval, batteries may fail, emit smoke, or catch fire.
GE Medical Systems recalls Vivid i N ultrasound machines worldwide because unreplaced batteries may fail, emit smoke, or catch fire. Users should replace batteries every 2 years per the service manual.
Corin Ltd is recalling BIOLOX Delta Ceramic Hip Implant Heads nationwide due to size labeling errors. The 36XL size is labeled as 32XL and vice versa, which could result in implantation of an incorrectly sized component.
ConvaTec is voluntarily recalling AQUACEL Foam Ag Adhesive wound dressings due to visual contamination (brown spots) found on several dressings. Approximately 5,300 units distributed nationwide are affected.
A hardened driveline cover on the HeartWare HVAD Pump Kit may prevent or delay access to the driveline to controller connector. If urgent servicing is needed, the delay could result in patient harm from pump malfunction.
The driveline cover on some HeartWare Model 1101 implanted pumps may harden over time, making it difficult to access the driveline connector. This could delay urgent maintenance, potentially causing patient harm.
It'll Be Pizza frozen pizza dough (20 oz and 24 oz packages) may contain foreign debris from packaging. Consumers should not consume affected products.
King Oscar Anchovies in Olive Oil are being recalled because they were found to contain elevated levels of histamine. The recall affects 263 cases distributed to wholesalers in Illinois and New Hampshire.
HeartWare HVAD Pump Kit driveline covers may harden over time, making it difficult or impossible to access the driveline connector for urgent servicing. Delayed access could result in patient harm from prolonged pump stoppage.
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
GE Healthcare is recalling B125M patient monitors because the CO2 measurement display can be inaccurate at locations above sea level when configured for mmHg or kPa units.
Medical Action Industries' Port a Cath Kit (cardiac catheter introduction kit) has been subject to an FDA Class II recall affecting 198 cases distributed in Virginia. The specific reason for recall was not provided by the FDA.
GE Medical Systems is recalling Vivid q N ultrasound systems due to potential battery failures that could emit smoke or catch fire if batteries are not replaced per the 2-year service manual recommendation.
PhoneSoap has recalled its SurfaceSoap UV Disinfecting Wand due to excessive ultraviolet-C radiation emission. Approximately 6,700 units distributed nationwide may pose a radiation hazard to users.
Circle K 22 oz Blonde Pizza Dough balls are being recalled due to potential contamination with foreign objects from packaging. Consumers with affected lots should not consume the product.
Glycopyrrolate tablets distributed nationwide are being recalled due to failed impurities and degradation specifications. Patients with affected lots should discontinue use and consult their healthcare provider.
HeartWare HVAD ventricular assist pump kits may develop hardened driveline covers that impair access to critical connectors. If urgent servicing is needed, delayed access could result in patient harm from prolonged pump stoppage.
Lupin Pharmaceuticals is recalling Quinapril tablets (20 mg) due to N-nitroso-quinapril impurity detected above acceptable daily intake limits. The recall affects approximately 23,736 units distributed nationwide.
It'll Be Pizza is recalling 22 oz Blonde, 20 oz Blonde EZ, and 24 oz Blonde EZ frozen pizza dough due to foreign object contamination from packaging. Products were distributed in Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire.
GE Vivid S6 N ultrasound systems may experience battery failure, smoke, or fire if batteries are not replaced every 2 years as recommended. Clinicians should replace batteries per manufacturer Service Manual instructions.
Rocky Mountain Pies is recalling Red Button Vintage Creamery French Silk Pies because some contain Turtle Cream Pies with almonds not declared on the label. Consumers with almond allergies are at risk.
It'll Be Pizza, LLC. is recalling EGA frozen pizza dough due to possible contamination with foreign objects from packaging debris. No illnesses have been reported.
The driveline cover on HeartWare HVAD Pump Kits may harden over time, preventing access to the driveline to controller connector. This could delay urgent intervention for critical device issues.
Driveline cover hardening in HeartWare HVAD Pump Kits may prevent access to critical connectors, potentially delaying emergency repairs. Affected patients should contact their Medtronic field representative for assessment.
Baxter Healthcare is recalling Revaclear 400 dialyzers due to reports of polyurethane displacement, which could result in blood leaks during dialysis treatment. The recall affects over 6 million units distributed worldwide.
Lupin Pharmaceuticals is recalling Quinapril 40mg tablets due to detection of N-Nitroso-quinapril impurity above acceptable daily intake limits. The recall affects approximately 30,612 bottles distributed nationwide.
DeVilbiss is recalling the 525 oxygen concentrator because the device can become excessively hot, with external parts potentially exceeding 105.8 degrees Fahrenheit. The firm has updated the user manual to include additional safety warnings.
GE Medical Systems recalled 1,400 Vivid S5 N ultrasound systems for batteries that may fail, emit smoke, or catch fire if not replaced every 2 years as recommended.
GE Medical Systems is recalling Vivid S5 ultrasound systems because batteries may fail if not replaced at the recommended 2-year intervals, potentially causing smoke or fire.
HeartWare Model 1100 driveline covers may harden over time, making it difficult or impossible to access the driveline-to-controller connector. A delay in accessing the connector during an urgent issue could result in prolonged pump stoppage and patient harm.
Brava frozen pizza dough products are being recalled due to possible contamination with debris from packaging. The recall affects 1,678 cases distributed in Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire.
GE B125M patient monitors may display inaccurate CO2 measurements at high elevations when using mmHg or kPa units. Measurement accuracy can be affected in locations significantly above sea level.
Fresenius Medical Care is recalling 2008T and 2008T Bluestar Hemodialysis Machines with CDX due to a software and hardware sensitivity to electromagnetic interference that triggers false alarms.
Corin Ltd is recalling BIOLOX DELTA ceramic hip replacement heads because some units are labeled with incorrect sizes. The recall affects 12 units distributed in seven U.S. states.
GE Medical Systems' Centricity Universal Viewer 6.0 image display software may hide medical studies from users after IAS tool installation, requiring GE assistance to access hidden images and causing delays in reading diagnostic studies.
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
GE is recalling Vivid q ultrasound systems because batteries not replaced every 2 years as recommended may fail and emit smoke or catch fire.
GE is recalling B125P patient monitors because CO2 measurements may be inaccurate when used at non-sea-level altitudes in mmHg or kPa mode.
Baxter Healthcare Corporation is recalling 3.6 million Revaclear 400 Dialyzers due to a manufacturing defect where a twisted gasket could cause internal blood leaks during hemodialysis treatment.
GE Medical Systems is recalling B105M patient monitors that display inaccurate CO2 readings when used at elevations above sea level. The issue affects monitors showing CO2 in mmHg or kPa units.
Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.
GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.
Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.
Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.
Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.
It'll Be Pizza is recalling Take 2 frozen pizza dough products (1,678 cases) distributed across Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire due to possible contamination with foreign debris from packaging.
Mercedes-Benz is recalling 2001-2011 C, CLK, E, and CLS class vehicles because the glass sunroof panel may detach, creating a road hazard.
Lion Electric is recalling 2020-2022 Lion6 and Lion8 vehicles because improperly tightened rear axle fasteners can cause suspension separation and loss of vehicle control.
Mercedes-Benz is recalling 2012-2020 GLE and ML models because water in the spare tire well can damage the fuel pump control unit, causing engine stalls.
Ford is recalling certain 2020-2023 Lincoln Aviators and Corsairs because the seat belt warning chime may activate for less than 4 seconds, failing to properly alert unbelted drivers.
Warn Industries is recalling wireless winch remotes because water intrusion can cause corrosion, leading to unintentional winch operation and injury risk.
Target is recalling about 204,000 Pillowfort Weighted Blankets because children can become entrapped inside the blanket cover, creating a risk of asphyxiation. Two children have died from this hazard.
Morasch Meats is recalling approximately 3,930 pounds of raw frozen diced beef products produced on August 24, 2022, due to possible E. coli O157:H7 contamination.
Samsung has recalled about 663,500 top-load washing machines because the machines can short-circuit and overheat, posing a fire hazard. A free software update is available to resolve the issue.
Shadow Trailer is recalling 2021-2022 Living Quarter travel trailers because damaged burner control valves may cause a gas leak, increasing fire risk.
Pacific Cycle is recalling about 147,000 Pacific Igniter and Pacific Bubble Pop 20-inch bicycles sold at Target because the handlebars can become loose during use, posing a fall hazard. Ten injuries involving bruising and abrasions have been reported.
KTM North America is recalling about 231 GASGAS MC 250 motorcycles due to an incorrectly programmed CDI box that can cause engine failure and pose crash and injury hazards. Consumers should stop riding the motorcycles immediately and contact an authorized dealer for a free repair.
Nova Medical Products is recalling approximately 20,000 Home Bed Rails (Models 6093 and 6094) because users can become entrapped within the bed rail or between the rail and mattress, posing a serious risk of death by asphyxiation.
BLU3 is recalling about 1,300 Nomad battery-powered tankless diving systems because the compressor head can fracture during use, restricting airflow and posing a drowning hazard to divers. No injuries have been reported.
Kibbi is recalling 2022–2023 Renegade Valencia motorhomes. Service valves on LPG tanks may be improperly connected, creating a propane leak risk that could lead to fire if an ignition source is present.
Honda is recalling approximately 19 model-year 2022 Acura TLX vehicles because their tires may have sustained cuts and tears. Damaged tires can lead to loss of vehicle control and increase crash risk.
Chrysler recalls 2022 RAM PROMASTER vehicles with an incorrect rearview camera that cannot be installed, reducing rear visibility and increasing crash risk.
REV Recreation Group is recalling certain 2021-2023 Holiday Rambler and Fleetwood motorhomes due to service valve defects on LPG tanks that may cause propane leaks and fire risk. Dealers will replace valves at no cost.
Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP) devices are recalled worldwide due to a potential issue with shortened battery run-times. All lot and serial numbers of model IAP-0700 are affected.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.
Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.
Arrow International recalls AC3 Optimus intra-aortic balloon pumps worldwide due to short battery run-times. The FDA issued a Class I recall affecting all lot and serial numbers.
Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.
BayCare Integrated Service Center is recalling 250 iohexol injection syringes mislabeled as 300 mg iodine/mL but actually containing 350 mg iodine/mL. The labeling error could result in dosing mistakes.
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Volkswagen is recalling 2015-2016 Beetle and Beetle Convertible vehicles because the driver's side air bag inflator may explode, posing a risk of serious injury or death.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow International is recalling 1,394 units of the Arrow AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times.
Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.
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