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
Gyroor C3 e-bikes are recalled because the battery pack can ignite, creating fire and burn hazards. Gyroor has received reports of battery packs igniting and injuries requiring medical treatment, including burns and smoke inhalation.
ESS Universal USA is recalling approximately 1,800 Waterproof Foam Mattresses sold online from April 2021 through March 2022 because they fail to meet mandatory federal flammability standards, posing a fire hazard.
About 30,100 Good Matters three-wick candles are being recalled because the candles can burn at higher than usual temperatures, causing glass jars to break and posing fire and laceration injury risks.
SIMU is recalling approximately 13,800 DMI6 Hz motors used in motorized awnings and shutters because the power cable can disconnect during manual operation, creating an electric shock and electrocution hazard.
Airstream is recalling certain 2017-2022 Basecamp travel trailers because the adhesive bond between the glass and frame of the entry door window can fail, causing glass separation and potentially increasing injury or crash risk.
Rosso Motors is recalling approximately 2,800 eQuad X and eQuad Q youth ATVs sold online from June 2019 through April 2021 because they violate federal safety standards and pose a risk of serious injury or death.
Samnyte Tattoo Numbing Cream is recalled because its packaging does not meet child-resistant requirements under federal law. The product contains lidocaine and poses a poisoning risk if ingested by young children.
Sundance Spas is recalling certain Jacuzzi and Sundance brand hot tubs because the temperature sensor may relay incorrect water temperatures, causing water hotter than the set temperature and posing burn and heat stroke hazards. No injuries have been reported.
Jayco and Entegra are recalling 2023 motorhomes because windshield wiper arms may break, causing wiper failure. This reduces visibility and increases crash risk in wet driving conditions.
Airstream is recalling 2022-2023 Interstate 24X motorhomes because overhead galley cabinet fasteners may fail, causing the cabinet to detach and increasing crash or injury risk.
GM is recalling certain 2023 GMC Terrain and Chevrolet Equinox vehicles with ventilated front passenger seats. The occupant detection system may fail to disable the airbag when a child is present, increasing crash injury risk.
Yokohama is recalling specific TY517 MC2 and BluEarth 109L tires due to a rubber compound defect that can cause tread separation and loss of vehicle control.
Crate and Barrel is recalling about 280 Thornhill baby cribs because mattress support pins can become loose or not fit properly, causing the mattress to fall. The firm received six reports of the mattress support pins not fitting correctly or falling out, though no injuries have been reported.
Gabriella White LLC (Gabby Home) is recalling approximately 930 D-Ring Fritz wall mirrors because the hanging mechanism can fail, causing the mirror to detach and fall from the wall. No injuries have been reported, but seven detachment incidents have occurred.
Remel Inc. is recalling Sensititre HPB1 diagnostic plates that may produce false susceptible results for specific bacteria when tested with seven antibiotics. This could lead to inaccurate susceptibility information affecting clinical treatment decisions.
Caire Inc. is recalling 70 CAIRE Liberator 45 liquid oxygen systems due to inconsistencies in weld penetration on the inner bottle's longitudinal weld seam discovered during an audit.
Boston Baking Mini Crumb Cake (3 oz, individually wrapped) is recalled for undeclared pecans. The product was distributed in six northeastern states and may pose a serious risk to consumers with tree nut allergies.
Ford is recalling certain 2022 and 2021 Bronco vehicles because the side impact sensors may not be properly secured. This could cause airbags to deploy unintentionally or fail to deploy in a crash, increasing injury risk.
Polestar is recalling 2020-2021 Polestar 1 vehicles because defective high-voltage battery cells may overheat and cause a fire. Dealers will replace the cells.
Audi is recalling 96 2022 E-Tron GT vehicles because a retaining ring on the front suspension strut may come loose, potentially causing air loss and loss of vehicle control.
Williamsen-Godwin is recalling specific trailers equipped with Smart-Steer 2.0 axles because the steering arm may fracture. This defect can cause parts to separate, increasing the risk of a crash.
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
Remel Inc. is recalling a diagnostic test that may incorrectly report antibiotic susceptibility in certain Gram-negative bacteria. False results could lead to inappropriate antibiotic treatment.
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
Caire, Inc. is recalling CAIRE Liberator 20 liquid oxygen system units due to weld penetration inconsistencies discovered during an FDA audit. The manufacturing defect affects 3 units.
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Sensititre diagnostic plates may give false antibiotic susceptibility results for certain bacteria species, potentially affecting treatment decisions. The FDA issued a Class I recall for approximately 1,917 units distributed nationwide.
GREEN DAY PRODUCE is recalling enoki mushrooms (UPC 16430-69080) due to Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors in 12 states.
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate treatment decisions.
CareFusion bipolar forceps recalled nationwide due to incomplete Instructions for Use missing power supply interface and cleaning information. The missing content could affect proper device operation and maintenance.
General Motors is recalling certain 2022-2023 Chevrolet Malibu vehicles with improperly welded front impact bars. The structural defect may prevent crash sensors from working correctly, increasing the risk of injury in a crash.
Ford is recalling certain 2021-2023 F-59, E-350, and E-450 vehicles. Paint peeling on fuel tank welds can cause corrosion and fuel leaks, creating a fire risk.
Philips is recalling the Upgrade to MR 7700 System (Model 782130) because the gradient coil may act as a heat source and produce smoke or fire. Affected units should not be operated until Philips provides further guidance.
Full Vision Inc. Trackmaster treadmills (Model #317-07926GE) may fail to stop during a fall if the magnetic safety mechanism malfunctions. 69 units are affected.
Gilman Cheese Corporation is recalling jalapeno cheese sticks due to the presence of plastic in the product. Consumers who purchased the recalled lots should discard them.
CareFusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing power supply interface and maintenance guidance.
CareFusion 2200 Inc is recalling 4,557 units of V. Mueller ADSON Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing content about power supply interface and cleaning and maintenance instructions.
Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.
Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical information about power supply interface and cleaning/maintenance procedures.
Big Sky Chocolate Chunk Peanut Butter Chip Granola (14oz) is being recalled because the product labeling fails to disclose milk allergen in its sub-ingredients. Consumers with milk allergies should not consume this product.
SUBURBAN BREAD CO. is recalling Big Sky Chocolate Chunk Granola (14oz pouches) because product labeling fails to declare milk, a sub-ingredient present in the granola. This poses a risk to consumers with milk allergies.
Nestle recalls Toll House Edible Chocolate Chip Cookie Dough (15oz tubs) for potential foreign material contamination. Approximately 18,671 cases affected across multiple US states.
Taylor Farms Northwest is recalling 539 units of Taylor Farms Jicama Sticks because a metal fragment was found in a package. The product was distributed in Washington with sell-by dates of 11/13/2022 through 11/17/2022.
Weis Quality ice cream contains undeclared soy and coconut allergens. Consumers with allergies should discard or return the product.
RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.
Carefusion is recalling the V. Mueller Bipolar Forceps Insulated due to missing instructions for power supply interface and cleaning/maintenance procedures.
Carefusion recalled 84 units of HARDY-STYLE BAYONET BIPOLAR FORCEPS nationwide and internationally due to incomplete Instructions for Use. The distributed documentation is missing information about power supply interface, cleaning, and maintenance procedures.
Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.
CareFusion V. Mueller bipolar forceps are being recalled because the provided Instructions for Use are missing critical content about power supply interface and cleaning/maintenance. The complete information is available in the manufacturer's full IFU.
BD recalled Carefusion bipolar forceps due to missing Instructions for Use content regarding power supply interface and cleaning/maintenance. Affected units distributed nationwide and internationally.
BD is recalling CareFusion bipolar forceps due to incomplete Instructions for Use. The IFU is missing critical information about power supply interface and cleaning/maintenance procedures.
Carefusion is recalling 418 units of bipolar surgical forceps because the provided instructions lack critical content about power supply interface and maintenance. Complete manufacturer instructions are necessary for safe device operation.
Carefusion bipolar surgical forceps recalled due to incomplete Instructions for Use missing critical content on power supply interface and maintenance procedures. Distributed nationwide and internationally.
Intersect ENT is recalling 611 units of Propel Mini Mometasone Furoate Sinus Implant due to incorrect product identification information on the label. The label displays wrong reference numbers and UDI-DI codes.
Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.
Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.
A warning has been added to the NextAR Shoulder surgical navigation platform advising verification of adequate coracoid bone stability. Inadequate stability could lead to bone fracture during reverse shoulder surgery.
Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.
BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.
Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.
CareFusion bipolar forceps have incomplete Instructions for Use missing power supply interface and maintenance guidance. Users should obtain complete instructions from the manufacturer before use.
Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.
CareFusion is recalling 1369 units of V. Mueller bipolar surgical forceps (Model F-1000) due to incomplete instructions for use. The provided instructions lack information about power supply interface and cleaning and maintenance procedures.
Carefusion is recalling 347 units of SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS due to incomplete Instructions for Use. The missing content covers power supply interface and maintenance procedures.
Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.
CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.
Full Vision Inc. is recalling TrackMaster treadmills due to a circuit defect in the safety tether. If the magnet detaches during a fall, the treadmill may fail to stop.
CareFusion 2200 Inc is recalling V. Mueller bipolar forceps (model F-5304) due to missing Instructions for Use content related to power supply interface and cleaning/maintenance procedures.
Full Vision Inc. TrackMaster treadmills with specific serial numbers have a circuit defect that may prevent the magnetic safety tether from stopping the treadmill during a fall.
Bunnell's 2.5 mm LifePort Endotracheal Tube Adapters may deform due to improper packaging, potentially affecting ventilator performance. The defect may lead to hypercarbia, hypoxia, and gas trapping.
Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.
ARASHAN brand mixed dried fruit (1 lb bags) is being recalled due to undeclared sulfites. The product was distributed in Illinois, New York, New Jersey, and Pennsylvania.
Taylor Farms Carrot-Celery Sticks (14 oz) are recalled due to a metal fragment found in a package. Affected products with sell-by dates 11/13-11/17/2022 were distributed in Washington.
Taylor Farms is recalling its 61 oz Guacamole Tray because a metal fragment approximately 3/4 inch was found in a retail package. The recall affects 161 units distributed in Washington.
Fresenius Medical Care is recalling 0.9% Sodium Chloride Injection due to lack of sterility assurance from potential leakage. The nationwide recall affects injectable saline bags distributed in the United States.
B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.
CareFusion recalls 142 units of bipolar surgical forceps due to incomplete Instructions for Use lacking power supply interface and maintenance guidance found in the manufacturer's version.
Carefusion is recalling surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and cleaning and maintenance procedures.
Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.
Randox Laboratories recalls IgM and IgA immunoturbidimetric assay kits due to carryover contamination that can cause elevated test results when run immediately after Fructosamine tests on RX instruments.
Full Vision Inc. Trackmaster treadmills have a rare circuit defect that may prevent the safety tether from stopping the machine during a fall.
Full Vision Inc. is recalling 38 TrackMaster TMX428 220V treadmills due to a rare circuit failure that may prevent the magnetic safety tether from stopping the machine during a fall.
CareFusion V. Mueller bipolar forceps (Ref F-5073) recalled due to missing critical instructions for power supply interface and cleaning and maintenance procedures. Users should obtain the complete Instructions For Use from the manufacturer.
BD is recalling Carefusion V. Mueller Bipolar Forceps due to incomplete Instructions for Use lacking critical content about power supply interface and cleaning procedures.
Philips is recalling 566 MR 7700 MRI systems nationwide. The gradient coil in these systems may overheat and produce fire or smoke.
Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.
Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.
Cardinal Health is recalling Dover urinary catheter trays due to potential blockage of the drainage bag inlet port, which may prevent urine drainage and increase the risk of urinary retention.
Eight Full Vision Trackmaster treadmills may fail to stop if the magnetic safety tether is pulled during a fall, due to a PCB circuit defect in the tether control system.
Full Vision Inc. is recalling 165 TrackMaster treadmills due to a circuit defect in the magnetic safety tether that may prevent the equipment from stopping when a user falls.
Siemens is recalling two lots of its IMMULITE Total Testosterone Assay due to a confirmed 40% positive measurement bias at higher testosterone levels, which may delay diagnosis and require repeat testing.
Cardinal Health is recalling Dover closed urethral catheter trays due to potential occlusion of the drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.
Carefusion is recalling 218 units of surgical bipolar forceps due to incomplete product instructions. The Instructions For Use is missing information about power supply interface and cleaning/maintenance procedures.
Carefusion recalls V. Mueller bipolar forceps with incomplete instructions. The device lacks critical information on power supply interface and cleaning procedures.
Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.
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