Archive
600 recalls were announced in December 2023.
Of the 600 recalls this month scored against our rubric, 5% are Critical, 35% are Severe.
Which agencies issued them
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.
Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.
Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.
Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.
Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.
IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.
Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.
Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.
Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.
Stryker is recalling ProCurity model 3009 patient beds because they lack required electrical safety testing, creating a risk of electrical shock or tissue burn. Affected units were distributed nationwide and internationally.
Stryker ProCuity patient beds lack required electrical safety test values, posing risk of tissue burn or electrical shock to patients and healthcare workers.
Stryker is recalling ProCurity patient beds (model 3009) due to missing electrical safety test documentation. Affected beds pose a risk of electrical shock or tissue burns. Facilities should verify their bed serial numbers and contact Stryker.
KinderFarms is recalling approximately 376,370 bottles of Infants' Pain and Fever acetaminophen oral suspension nationwide due to failures in impurity and degradation specifications.
Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.
Stryker Medical is recalling ProCuity bed series model 3009 due to missing electrical safety test values. The beds pose a risk of electrical shock or tissue burn to patients.
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
Thor Photomedicine is recalling six THOR NOVO GEN 2.0 XL whole body red light therapy beds due to ball stud component failure. The defect causes gas strut detachment, making the canopy difficult to lift.
BAPS Shayona burfi (sweetened ricotta fudge) is recalled due to undeclared soy allergen. The product was distributed to AL, FL, GA, NC, SC, and TN.
Recall of approximately 1,019 Elekta Synergy radiation therapy systems due to potential uncontrolled extension of detector arms if the middle arm microswitch is incorrectly setup.
Stryker is recalling ProCuity patient beds (model 3009) for missing electrical safety test values, which presents risk of electrical shock or tissue burn.
Scoular Grain Co is recalling 40,000 pounds of Milled Brown Flax (lot REG23268) distributed in Texas and Canada due to plastic foreign object contamination. The product poses a choking and injury hazard if consumed.
Integra LifeSciences Corp. is recalling 173 units of its Cranial Access Kit due to a packaging defect that can split and compromise device sterility. No illnesses have been reported.
Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.
Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.
CardioQuip Modular Cooler-Heater units are being recalled due to a potential heating-chamber malfunction that could cause melting and burning of internal components. 125 units distributed across 15 US states are affected.
Stryker Medical is recalling ProCuity hospital beds with missing electrical safety test documentation, creating risk of electrical shock or tissue burns.
The Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr catheter may detach or leak due to defective bonding material used in assembly. The 73 affected units were distributed nationwide and internationally.
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.
Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.
BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
Hans Kissle Potato Salad White Homestyle (10 lb. bulk cases) is being recalled for undeclared egg and soy allergens. The recall affects units distributed in Connecticut and Massachusetts with a use-by date of November 25, 2023.
Vermont Village Organic Unsweetened Apple Sauce (24oz) is being recalled due to elevated patulin levels. Consumers should not consume the product and should discard or return it.
BAPS Shayona is recalling Kopra Paak Coconut Fudge (12 oz, code A06D2023) for undeclared soy, a major allergen. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
BAPS SHAYONA Surti Ghari sweet dumplings are recalled due to undeclared soy and Yellow #6 dye. The product was distributed in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
BAPS Shayona Sangam Katri Rose and nut fudge is recalled because it contains undeclared soy. The product was distributed to six states: Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.
BAPS Shayona is recalling Mohanthal (chickpea flour fudge) distributed in six states due to undeclared soy and dyes (Yellow #5, #6). The product poses risk to consumers with soy allergies or sensitivities.
Garden of Life FYI ULTRA Joint & Cartilage Formula dietary supplement recalled due to undeclared soy. Consumers with soy allergies should not use affected bottles.
BAPS Shayona is recalling 723 units of Plain Penda Ricotta fudge discs because some contain undeclared soy. The product was distributed to six states and poses a risk for those with soy allergies.
BAPS Shayona Kaju Pista Roll sweet rolls are being recalled because they contain undeclared Yellow #5, Yellow #6, and Blue 1 food dyes. The recall affects 138 units distributed to six southern states.
Scoular Grain Co is recalling Milled Golden Flax MGDF in 50 lb bags due to plastic foreign object contamination. Affected lot numbers REG23261 and REG23268 were distributed to Texas and Canada.
Padagis US LLC is recalling Trospium Chloride Extended-Release Capsules (60 mg) due to manufacturing defects where some capsules contain missing, broken, or extra tablets. The recall affects 7,032 bottles distributed nationwide.
Wells Pharma is recalling 825 syringes of injectable ceFAZolin sodium distributed in Philadelphia, Pennsylvania, due to lack of assurance that the product meets required sterility standards.
Baxter Healthcare Corporation is recalling approximately 6 million vials of Ondansetron Hydrochloride injection due to manufacturing defects where pH levels failed to meet specifications.
KinderFarms is recalling KinderMed KIDS' PAIN & FEVER Acetaminophen oral suspension nationwide due to failed impurity and degradation specifications that do not meet FDA standards.
Integra LifeSciences is recalling 59 Integra Cranial Access Kits due to outer packaging that can split without external force, compromising device sterility. Affected units (Lot 6837706, exp. 1-Mar-25) should be discontinued immediately.
Elekta is recalling 264 units of its Synergy Platform radiation therapy systems due to a microswitch defect that could cause uncontrolled extension of detector arms. The systems were distributed worldwide.
Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.
Certain Elekta Versa HD radiation therapy systems may experience uncontrolled detector arm extension due to microswitch setup issues. This recall affects 451 systems worldwide.
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
Carestream Health is recalling the DRX Revolution Mobile X-Ray System due to unexpected failure of electrical components in the CPI generator. The recall affects approximately 3,961 units distributed worldwide.
AURIS HEALTH INC is recalling approximately 110 units of the Monarch Platform bronchoscopy surgical device due to a software defect that can flip the displayed image during procedures. No injuries have been reported.
CooperSurgical is recalling H/S ELLIPTOSPHERE CATH 5 FR Sets (169 units) due to incorrect bonding material that may cause component detachment or leakage, potentially delaying diagnostic procedures.
Stanbio Laboratory is recalling STAT-Site M BHB Test Strips due to stability deterioration that causes false negative results. This defect may delay diagnosis and treatment of patients with conditions such as diabetic ketoacidosis.
CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.
Abiomed is recalling Automated Impella Controller units with software versions V8.4 and V8.4.1 because a software issue may prevent proper pump connection detection. Affected devices were distributed in Arizona, California, Florida, New York, and Virginia.
Stryker's ProCuity bed series (model 3009) is being recalled due to missing electrical safety test documentation. The beds present a potential risk of electrical shock or tissue burn.
Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.
CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.
Stryker ProCuity beds (model 3009) are missing electrical safety test values, presenting risks of electrical shock and tissue burns. FDA Class II recall.
Auris Health is recalling 110 units of the Monarch Platform bronchoscope due to a software defect that may flip the image display. This inverted view could impact visualization during airway procedures.
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.
Thor Photomedicine is recalling 19 NovoTHOR Gen 2.0 red light therapy beds due to ball stud component failures that can cause canopy detachment or difficulty in lifting. The beds were distributed worldwide.
Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.
Encore Medical is recalling 37 DJO surgical EMPOWR Porous Knee System SIZE 8 devices distributed nationwide because incorrect product components were packaged with certain units.
Integra LifeSciences recalled the Integra Cranial Access Kit (160 units) due to a defect in the outer packaging that can split and compromise device sterility, creating an infection risk for neurosurgical procedures.
Integra LifeSciences is recalling the Integra Cranial Access Kit due to a defect in the outer packaging that can split and compromise device sterility. A total of 173 units are affected.
Heartware is updating instructional materials for the HVAD ventricular assist device to clarify when Controller Fault alarms sound and how to troubleshoot them. Updates also address component useful life instructions.
Stryker is recalling ProCuity patient beds (model 3009) for missing required electrical safety test documentation, creating a risk of electrical shock or tissue burn.
HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.
AURIS Health is recalling the Monarch Platform virtual bronchoscope due to potential software issues that may flip the displayed surgical image, which could impair visualization during minimally invasive procedures.
Thor Photomedicine is recalling 26 NovoTHOR Gen 2.5 XL red light therapy beds due to ball stud component failure that can cause the gas strut to detach, making the canopy difficult to lift.
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.
Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.
Abiomed is recalling Automated Impella Controller (AIC) software versions V8.4 and V8.4.1 due to a software issue that may prevent the pump from being detected as connected to the controller. Devices were distributed in Arizona, California, Florida, New York, and Virginia.
Ortho-Clinical Diagnostics is recalling certain VITROS ECO2 diagnostic slides that may produce inaccurate carbon dioxide measurements, potentially leading to misdiagnosis of acid-base balance disorders.
Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.
BioFire Diagnostics is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panels due to instrument characteristic changes that cause Candida tropicalis to be detected but reported as 'Not Detected' in quality control testing.
BAPS Shayona is recalling Badam Pista Sandwich due to undeclared Yellow #5 and Green 3 color additives. The product was distributed to six states.
BAPS Shayona is recalling approximately 674 units of Motichur Ladoo across six states due to undeclared Yellow #5 and Yellow #6 food dyes discovered during an FDA inspection.
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
Remington Medical is recalling drainage bags (Lot 2325111) due to errors in the 'Use by Date' and 'Date of Manufacturer' on box labels. Approximately 3,080 units distributed in PA and FL are affected.
Heartware, Inc. is updating instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and component useful life. The recall affects 45 units distributed worldwide.
Heartware is updating instructions for HVAD ventricular assist device implant kits to clarify Controller Fault alarm conditions and troubleshooting steps, as well as useful life information for system components.
Right Value Drug Stores is recalling LET Gel topical anesthetic syringes nationwide due to incorrect product formulation. Patients should not use affected syringes and should consult their healthcare provider.
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Sun Pharmaceutical is recalling Bupropion Hydrochloride Extended-Release Tablets 200 mg due to failed dissolution specifications. The recall affects 2,016 bottles with lot HAD0630A distributed nationwide.
Liberty Medical Solutions is recalling 473 Multi-Mode TENS stimulator units distributed in five states due to missing warnings and contraindications in instruction manuals.
The FDA is issuing updated instructions for the HeartWare HVAD ventricular assist device to clarify when controller fault alarms sound and when device components should be replaced. No patient harm has been reported.
Great Dane is recalling 2024 Champion trailers because improperly tightened axle spindle nuts could allow wheels to detach, increasing crash risk.
Tesla is recalling 2.03 million 2012-2023 Model S/X/3/Y vehicles with Autosteer due to insufficient control prominence that may allow driver misuse and crash risk. A free OTA software update will be provided.
Mazda is recalling 2004-2006 B-Series trucks because previously replaced front passenger air bag inflators may have been installed incorrectly, potentially preventing proper inflation during a crash.
REV Recreation Group is recalling 2016-2023 American Coach American Eagle motorhomes because turbulence may loosen or break the rear air deflector mounting bracket hardware.
Harley-Davidson is recalling certain 2023 FLHXSE motorcycles due to an engine control module software defect that may cause loss of control at high speeds, increasing crash risk.
Mercedes-Benz is recalling 2021-2022 GLE 350 and GLE 450 vehicles because a 12-volt ground connection may overheat, increasing the risk of a fire.
Forest River is recalling 2024 XLR Boost toy haulers because taillights may be insufficiently reflective, reducing visibility and increasing crash risk.
Looking for a different month? Back to 2023.