Archive
567 recalls were announced in December 2019.
Of the 567 recalls this month scored against our rubric, 8% are Critical, 32% are Severe.
Which agencies issued them
Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.
Anazao Health is recalling Morphine Sulfate products because environmental sampling detected Talaromyces rotundus, a type of fungus.
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.
Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in suboptimal staining.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Anazao Health is recalling Clonidine HCL, Baclofen, and Fentanyl Citrate products due to the detection of Talaromyces rotundus fungi.
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.
Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.
Edney and Sellers, Ltd. is recalling Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake due to reports of plastic pieces found in the product.
Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.
Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.
DePuy Mitek is recalling 299 Healix Knotless ADV BR 4.75 Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.
Pfizer is recalling 77,100 syringes of 25% Dextrose Injection because the expiration date printed on the syringes is incorrect.
Glenmark Pharmaceuticals is recalling Clobetasol Propionate Foam because the product is not foaming or is coming out as liquid.
Glenmark Pharmaceuticals is recalling Clobetasol Propionate Foam because the product is not foaming or is coming out as liquid.
Oliver Travel Trailers is recalling 2017-2019 Elite II travel trailers because improperly tightened axle bolts may affect braking or cause wheel detachment.
Prevost is recalling 2020 X3-45 and H3-45 coach buses because driveshaft clamp bolts may not be properly tightened, which could cause loss of drive or a road hazard.
J. Crew is recalling specific boys' denim pants because small stones from the manufacturing process may remain in the pockets or waistband, posing a choking risk to young children.
Foretravel is recalling 2020 Realm and iH45 vehicles because a brake relay valve defect may increase stopping distance, raising crash risk.
Mack Trucks is recalling 2020 Anthem, Granite, and Pinnacle vehicles because steering drag link connections may be improperly installed, risking loss of steering control.
Maintainer is recalling one 2019 Custom Body Heavy Rescue vehicle because front shocks may separate, potentially causing a steering fluid leak and loss of power steering assist.
Mercedes-Benz is recalling certain 2015-2018 CLA models because the passenger air bag may not deploy properly in a crash, increasing injury risk.
Mack Trucks is recalling 2019-2020 TerraPro vehicles because improperly aimed headlamps may reduce driver visibility, increasing crash risk.
Forest River is recalling 2020 Georgetown and FR3 motorhomes because trailer hitch bolts may not be properly tightened, posing a crash risk while towing.
USDA FSIS issued a public health alert for H-E-B Butter Chicken Soup due to undeclared wheat and soy allergens.
Chrysler is recalling 2005-2006 Dodge Viper vehicles because the Occupant Restraint Control module may inadvertently deploy air bags and seat belt pretensioners, increasing injury risk.
Maintainer is recalling one 2019 Custom Body Heavy Rescue vehicle because a brake relay valve defect may cause extended stopping distances, increasing crash risk.
General Motors is recalling 2019-2020 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because excessive glue on the battery cable may cause electrical arcing, stalling, or fire.
Chrysler is recalling 2019 Ram 1500 trucks because an incorrect Tire Pressure Monitoring System sensor may prevent low tire pressure warnings from displaying.
General Motors is recalling 2019 Chevrolet Silverado 1500, GMC Sierra 1500, and Cadillac CT6 vehicles because a software error may disable Electronic Stability Control and Antilock Brake Systems without warning.
Chrysler is recalling 2018-2019 Pacifica minivans because a software error may keep the rearview camera image on the radio display after shifting out of reverse, potentially distracting the driver.
Vinyard Fruit & Vegetable Co. is recalling 5LB bags of Red Dragon Blend mix due to potential Listeria monocytogenes contamination. The product was distributed in Oklahoma and Arkansas.
GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
Vinyard Fruit & Vegetable Co. is recalling 80003 Broccoli Cheddar Pasta Salad Kits due to potential Listeria monocytogenes contamination. The product was distributed in Oklahoma and Arkansas.
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg because the FDA detected the NDMA impurity in the product.
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulate matter.
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine infusions due to the potential presence of glass particulate matter.
GE Healthcare is recalling Giraffe OmniBed Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of particulate matter, including potential glass particles.
BMW is recalling 2019-2020 M5 and 2020 M8 vehicles because a damaged transmission wiring harness can cause an electrical short, leading to loss of propulsion and increased crash risk.
Ford is recalling 2017-2019 F-Super Duty trucks because seat belt pretensioner sparks could ignite B-pillar materials, potentially causing a vehicle fire.
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected in the product.
Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.
QuVa Pharma is recalling fentanyl 50 mcg/mL syringes because of potential glass particulate matter. The recall covers multiple lots distributed nationwide.
Vinyard Fruit & Vegetable Co., Inc. is recalling 7109 Veg Kit products due to potential contamination with Listeria monocytogenes.
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets nationwide because NDMA impurity was detected. This action addresses CGMP deviations.
Volkswagen is recalling 2019 Jetta GLI, Golf Alltrack, and Golf GTI vehicles because improperly machined front wheel bearings may cause excessive stress, increasing the risk of a crash.
QuVa Pharma is recalling specific lots of fentanyl PCA vials due to the potential presence of glass particulate matter.
QuVa Pharma is recalling specific lots of fentanyl infusion solutions due to the potential presence of glass particulate matter.
Triple E is recalling 2020 Unity U24RL trailers because propane tubing may contact tires, posing a fire risk. Dealers will install protective shields.
QuVa Pharma is recalling fentanyl and bupivacaine IV bags due to the presence of particulate matter, specifically potential glass particles.
QuVa Pharma is recalling fentanyl 550 mcg/55 mL syringes due to the presence of glass particulate matter.
QuVa Pharma is recalling specific lots of fentanyl infusion bags due to the presence of glass particulate matter.
QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.
Vinyard Fruit & Vegetable Co. is recalling 1,066 cases of 3570 Mix, TEDs Vegetable due to potential Listeria monocytogenes contamination.
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 75 mg tablets because the FDA detected the NDMA impurity in the product.
Honey Heaven Wholesale Inc is recalling Hummingbird Wholesale Organic Chia Seeds due to a metal bar found in the product. The metal bar had a jagged edge and loose flakes.
Vinyard Fruit & Vegetable Co. is recalling specific broccoli products due to potential Listeria monocytogenes contamination. The products were distributed in Oklahoma and Arkansas.
GE Healthcare is recalling Giraffe Incubator Carestations because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
Kettle Cuisine is recalling Marketside Creamy Cauliflower Parmesan Soup because it may contain undeclared fish and wheat.
Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.
Medtronic is recalling Synchromed II programmable pumps due to a potential foreign particle that could cause a permanent motor stall.
Sanofi-Aventis U.S. LLC is recalling Maximum Strength Zantac 150 mg tablets nationwide because the FDA detected the NDMA impurity in the product.
QuVa Pharma is recalling specific lots of fentanyl 2500 mcg/50 mL bags nationwide due to the presence of glass particulate matter.
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.
Givaudan Flavours Corp is recalling Nat Maple Flavor WONF because metal material was found in a raw ingredient used during production.
Sanofi-Aventis U.S. LLC is recalling Cool Mint Maximum Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected.
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection due to the presence of particulate matter, including potential glass particles.
QuVa Pharma is recalling specific lots of fentanyl and bupivacaine injection bags due to the presence of particulate matter, including potential glass particles.
Sanofi-Aventis U.S. LLC is recalling Regular Strength Zantac 150 mg tablets nationwide because an NDMA impurity was detected. This action addresses current good manufacturing practice (CGMP) deviations.
Mill Stream Corp. is recalling Sullivan Harbor Farm Smokehouse cold smoked salmon because the product had low water phase salt levels.
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine infusions due to the potential presence of glass particulate matter.
Vinyard Fruit & Vegetable Co. is recalling Joseppi's Vegetable Mix in 5LB and 4/5# bags due to potential Listeria monocytogenes contamination. The product was distributed in Oklahoma and Arkansas.
Sanofi-Aventis U.S. LLC is recalling Zantac 150 mg tablets nationwide because an NDMA impurity was detected in the product.
QuVa Pharma is recalling specific lots of a fentanyl and bupivacaine infusion due to the presence of glass particulates.
Vinyard Fruit & Vegetable Co. is recalling 3512 California Medley packaged in plastic flexible bags due to potential contamination with Listeria monocytogenes.
Sanofi is recalling Cool Mint Tablets Maximum Strength Zantac 150 mg nationwide because NDMA impurity was detected in the product.
Givaudan Flavours Corp is recalling Nat Strawberry Banana Flavor WONF because metal material was found in a raw ingredient used during production.
GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.
QuVa Pharma is recalling specific lots of fentanyl and ropivacaine injection bags due to the presence of glass particulates.
Sanofi-Aventis U.S. LLC is recalling Zantac 75 mg tablets nationwide because NDMA impurity was detected. The recall covers all lots of the product.
QuVa Pharma is recalling fentanyl syringes due to the potential presence of glass particulate matter. The recall is classified as FDA Class II.
QuVa Pharma is recalling fentanyl injection bags due to the potential presence of glass particulates.
Sanofi is recalling Regular Strength Zantac 75 mg tablets nationwide because an NDMA impurity was detected in the product.
QuVa Pharma is recalling fentanyl 100 mcg/2 mL injections because of potential glass particulate matter. The recall covers specific lots distributed nationwide.
Givaudan Flavours Corp is recalling Nat Bacon (smoky) Flavor WONF because metal material was found in a raw ingredient used during production.
Stryker is recalling 16,380 disposable tourniquet cuffs because they may leak air, causing a loss of vascular occlusion during surgery.
Lamb Weston is recalling Crispy Hash Brown Dices because the product may contain pieces of hard rubber material.
Frog Hollow Farm is recalling 60 Holiday Fruitcakes because walnuts were not listed on the ingredient label, posing an allergen risk.
Zimmer Biomet is recalling 34 units of 14MM Intramedullary Bone Saw Cam Assemblies because some were labeled as 14MM but measured as 13MM.
QuVa Pharma is recalling fentanyl and bupivacaine injection bags due to the presence of particulate matter, specifically potential glass particles.
Steris Corporation is recalling 237 Evolution Loading Cars and Transfer Carriages because a locking pin defect may cause the equipment to fall forward unexpectedly.
CooperSurgical is recalling Quantum 2000 Electrosurgical Generators because they may stop cutting, coagulating, or blending during procedures when the foot pedal is used.
Steris is recalling 236 Eagle 3000 Small Steam Sterilizers because the preventive maintenance kit may contain an incorrect pressure safety valve.
QuVa Pharma is recalling fentanyl 250 mcg/5 mL syringes due to the presence of glass particulate matter. The recall is nationwide.
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