Archive
446 recalls were announced in December 2021.
Of the 446 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.
Which agencies issued them
ASP Cares is recalling Methylcobalamin Solution for Injection due to lack of assurance of sterility. The recall affects one lot distributed in the United States.
Onions 52 is recalling 40-pound cartons of Jumbo Yellow Onions imported from Chihuahua, Mexico, due to possible contamination with Salmonella Oranienburg. The recall is voluntary and covers products distributed nationwide and in select regions.
Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.
Puratos Corporation is recalling Easy Satin Creme Cake Bag 50# (Batch Number 10644902) due to possible contamination with metal foreign material. The affected product was distributed to domestic and international customers.
Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.
BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.
Trail Toddy & Company LLC is recalling Mocha Irish Coffee packets because milk is not declared on the label, though the product contains cream and dairy, creating a risk for consumers with milk allergies.
GE Appliances is recalling approximately 132,000 free-standing and slide-in electric and gas ranges because they can tip over if a heavy object is placed on an open oven door and the anti-tip-over bracket is not securely installed, risking burn injuries.
Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.
Carson is recalling 2018-2020 Fun Runner FC20 trailers because an overtightened bolt may damage the stove's o-ring, causing a gas leak that increases fire risk.
Flowers Foods is recalling Tastykake Buttercreme Iced Creme Filled Chocolate Cupcakes due to potential small metal fragments in an ingredient. The recall affects products distributed across multiple states.
Puratos Corporation is recalling Shirley's Choc Whoopie Pie Base because the product may contain metal foreign material. Affected batches were distributed to customers in multiple U.S. states and internationally.
O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.
Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.
Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.
Mark of Fifth Avenue children's robes do not meet federal flammability standards for sleepwear and pose a risk of burn injuries. About 10,000 units sold online at Amazon and Walmart from August 2019 through June 2021 are affected.
Puratos Corporation is recalling Teg Satin Supreme Yogurt Creme (50 lb bags) due to potential contamination with metal fragments. The product was distributed to customers across multiple US states and internationally.
Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.
Puratos Corporation is recalling Shirley's Red Velvet WhoopiePie MB Bg 50# due to potential metal contamination. The product was distributed to customers across multiple U.S. states and foreign locations.
Puratos Corporation is recalling NSA Creme Cake in 50-pound bags due to potential metal contamination. The product may pose a choking or injury hazard.
MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.
Flowers Foods is recalling Tastykake Butterscotch Krimpets in multiple sizes due to the potential presence of small metal fragments in one of the ingredients. The product was distributed across 36 states.
Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.
Puratos Corporation is recalling Teg H/A Cream Cake Bag 50# (Batch Number 10730404) due to potential contamination with metal foreign material. The product was distributed to customers in multiple U.S. states and internationally.
Onions 52 is voluntarily recalling 5-pound cartons of Jumbo Red Onions labeled Imperial Fresh due to possible Salmonella Oranienburg contamination. The onions were imported from Chihuahua, Mexico and distributed nationwide.
Flowers Foods is recalling certain Tastykake Creme Filled Krimpets due to potential small metal fragments in an ingredient. The recall affects products distributed to 37 states.
Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.
Keurig Dr Pepper is recalling 7UP Zero Sugar Lemon Lime Soda due to unlabeled sulfites detected after customer complaints about off flavor and aroma. The recall affects 9,152 cases distributed nationwide.
Puratos Corporation is recalling Dulcerio Sponge Cake Mix Bag 40# (Batch Number 10644901) due to possible contamination with metal foreign material. The product was distributed to customers in multiple U.S. states and internationally.
Flowers Foods is recalling Tastykake Jelly Krimpets due to potential small metal fragments in an ingredient, as reported by a supplier. The recall affects 12oz and 3oz packages distributed across 37 US states.
Flowers Foods is recalling Tastykake Chocolate Cupcakes 12.75oz boxes due to the potential presence of small metal fragments in an ingredient. The product was distributed across 36 U.S. states.
Target Good & Gather Mixed Berry Sparkling Water in 8-packs is being recalled due to unlabeled sulfites. Keurig Dr Pepper discovered the issue after receiving complaints about off flavor and off aroma.
Puratos Corporation is recalling HEB Satin White Layer Cake in 50-pound bags due to possible contamination with metal foreign material. The affected product was distributed across multiple U.S. states and internationally.
Murray International Trading Co., Inc. is recalling "Herbal Doctor" brand Angelicae Sinensis herb packages due to elevated levels of lead and cadmium contamination. The product has been distributed to consumers across the eastern and central United States.
Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.
Onions 52 is voluntarily recalling Medium Red Onions imported from Chihuahua, Mexico due to possible contamination with Salmonella Oranienburg. The affected products were distributed nationwide.
Puratos Corporation is recalling Shirley's Sugar Top Muffin Base (15,950 lbs) because the product may contain metal foreign material. The affected batches were distributed to customers in multiple U.S. states and internationally.
Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.
RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.
Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.
Motts LLP is recalling Motts No Sugar Added Apple Sauce 3.9 oz. cups because the product may contain metal fragments. Consumers should not consume the product and should contact Motts for more information.
Puratos Corporation is recalling One Step Neutral/Vanilla Mousse (Batch 10672511) due to potential contamination with metal fragments. Affected domestic and international customers should not use the product.
Keurig Dr Pepper is recalling Target Good & Gather Coconut Pineapple Sparkling Water because some cans contain unlabeled sulfites. The affected products were distributed nationwide.
Keurig Dr Pepper is recalling Polar Black Cherry Premium Seltzer 12-packs due to unlabeled sulfites. The recall affects 7,849 cases distributed nationwide with product code date 12/16/2022.
Trail Toddy & Company LLC is recalling Spiced Irish Coffee Hint of Cocoa packets because milk is not declared on the label despite cream powder being present in the product. The product was distributed in Illinois, Montana, and Massachusetts.
Puratos Corporation is recalling Shirley's Neutral Whoopie Pie MB Bag 50# (Batch Number 10584012) due to potential metal contamination. Consumers should not use the product.
Puratos Corporation is recalling Teg Satin Choc Creme Cake (50 lb bags, Batch 10688839) due to possible contamination with metal. The product was distributed across multiple states and internationally.
Puratos Corporation is recalling Finesse Bag 25# (Material #4107218, Batch Number 10644766) because the product may be contaminated with metal fragments. The product was distributed domestically and internationally.
Trail Toddy & Company LLC is recalling Classic Irish Coffee Hint of Cocoa packets because milk is not declared on the label, though the product contains dairy ingredients. The recall affects products distributed in Illinois, Montana, and Massachusetts.
Puratos Corporation is recalling Dom. Creme Ck Bag 50# (Batch Number 10584006) due to possible contamination with metal fragments. The product was distributed domestically and to select foreign locations.
Puratos Corporation is recalling TK014 Choc Creamie Powder Blend in 40 lb. bags due to potential metal contamination. The affected product was distributed domestically and internationally.
Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.
The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.
GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.
Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.
Puratos Corporation is recalling Easy Satin Supreme Creme Cake Bag 50# due to potential metal contamination. The affected product was distributed to bakery and food manufacturers in twelve U.S. states and two Caribbean countries.
Puratos Corporation is recalling approximately 119,900 lbs of TK019 2017 Choc Cup Powder Blend due to potential metal contamination. Affected batch numbers are 0010636571 and 0010636577.
Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.
Puratos Corporation is recalling Teg Creme Cake Bags (50 lb) because they may contain foreign metal material. The affected product was distributed to customers in multiple U.S. states and internationally.
DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.
Puratos Corporation is recalling Teg Moist'r Yellow Layer Cake Mix (50# bag, Batch Number 10737143) due to potential metal contamination. The product was distributed to customers across 12 U.S. states and 2 foreign countries.
Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.
Flowers Foods is recalling Tastykake Chocolate Creme Filled Cupcakes due to the potential presence of small metal fragments in an ingredient. The affected product has an "Enjoy By" date of December 14 or December 18.
NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.
Puratos Corporation is recalling TK006 Van Krimpet Powder Blend (50 lb bags, item number 4107780) because the product may contain foreign metal material. The affected batches are 0010636568 and 1110644921.
Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.
Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.
Hyundai is recalling 2,679 Ioniq Electric vehicles because an unstable electrical ground may cause unexpected acceleration after the gas pedal is released.
Great Dane is recalling 2022 Champion and Everest trailers because insufficient wheel hub lubrication could cause bearing failure and loss of control.
Drive DeVilbiss Healthcare is recalling four models of adult portable bed rails that can trap users between the rail and mattress, causing asphyxiation. Two deaths have been reported.
Winnebago is recalling approximately 401 model-year 2022 Ekko recreational vehicles. The shower and sink drainage system may leak, causing water infiltration that can lead to electrical fire.
Dennis Eagle is recalling 2017-2021 Elite and Proview vehicles because the instrument cluster may falsely indicate an exterior light is off, potentially masking actual failures.
Alexander & Hornung is recalling approximately 2.3 million pounds of fully cooked ham and pepperoni products due to possible Listeria monocytogenes contamination.
Erie Meat Products Ltd. is recalling approximately 1,224 pounds of chicken bologna imported into the U.S. without FSIS reinspection. The products were distributed to correctional institutions in four states.
Zero Motorcycles is recalling 2022 SR, SR/F, and SR/S motorcycles because incorrect rear brake pads were installed, which may not work as intended and increase crash risk.
Hyundai is recalling certain 2021 Accent vehicles due to a brake master cylinder defect. The component may have sharp edges that damage the inner oil seal, reducing braking performance and increasing crash risk.
Honda is recalling certain 2021 Acura RDX vehicles because the front driveshaft may have been improperly heat-treated, potentially causing driveshaft failure and sudden loss of drive power or vehicle rollaway.
Hyundai is recalling 2022 Tucson vehicles with incompatible ICU software that can disable headlights and taillights, reducing visibility and increasing crash risk. All affected vehicles have been repaired.
E-filliate is recalling about 301,800 DEWALT Jobsite Pro Wireless Earphones because they can overheat during charging or use, posing burn and fire hazards. The company has received 61 reports of overheating, including five fires and four minor burn injuries.
Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because improperly tightened rear step bolts could allow the step to separate, creating a road hazard.
Kia Motors recalls 2020–2021 Rio vehicles due to brake master cylinder manufacturing defects that can reduce braking performance. The defect may cause longer pedal travel and extended stopping distance, increasing crash risk.
HALO Branded Solutions Inc. is recalling about 82,500 children's projector flashlights distributed in care packages because children can disassemble them and access button cell batteries, creating ingestion and choking hazards. Two incidents have been reported, including one requiring surgery.
MaryRuth's Organic Infants Liquid Probiotic dietary supplement is being recalled because internal testing found Pseudomonas aeruginosa contamination. The affected product is distributed nationwide.
Cummins is recalling X12 Diesel Engines because fuel tubes may crack, causing high-pressure leaks that increase fire risk.
Daimler Vans USA is recalling 2021 Mercedes-Benz and Freightliner Sprinter vans because the front fender liner may damage the brake hose, increasing crash risk.
Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.
Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.
Medtronic is recalling 7 Cardioblate CryoFlex Surgical Ablation Consoles due to potential intermittent electrical connectivity loss between the console and probe.
Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
Clek is recalling specific Liing and Liingo infant child seats because a plastic canopy support part may break and detach, creating a choking hazard.
Volkswagen Group of America is recalling 2022 Audi E-Tron GT vehicles because a loose retaining ring on air suspension struts may compromise handling and increase crash risk.
Clek is recalling specific Foonf and Fllo convertible child seats because loose foam pieces can pose a choking hazard to children.
Western/Scott Fetzer is recalling Digital VIPR devices (Model MNDR-600) due to battery rupture risk that could cause plastic shroud breakage and fume emission. The recall affects 4974 units distributed from May 2020 to August 2021.
Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.
Medtronic is recalling 511 Endurant II Stent Graft Systems because during deployment, the spindle may detach from the distal end of the spindle hypotube.
Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.
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