Archive
527 recalls were announced in September 2022.
Of the 527 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.
Which agencies issued them
American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.
Select Bakery is recalling Old Fashion Pineapple Creme Cake (3 oz) due to undeclared soy. The voluntary recall affects products distributed in Georgia, North Carolina, and South Carolina.
American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.
American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.
CIPLA is recalling 3,468 bottles of Difluprednate Ophthalmic Emulsion nationwide due to defective protective caps that could expose the dropper tip and compromise sterility. No injuries have been reported.
Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.
Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.
Piantedosi Baking Co. recalls Gourmet Potato Deli Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected frozen products distributed across 15 states; consumers should check lot codes 22081-22115 with March-April 2023 expiration dates.
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Charlie's brand Spinach Salad With Honey Dijon Dressing is recalled due to undeclared fish (anchovy) in the Worcestershire sauce dressing. Consumers with fish allergies are at risk.
OrthoPediatrics Corp is recalling an external fixation wire due to manufacturing variance that may cause the tip to fracture. Fractured fragments could remain in patients.
Select Bakery Old Fashion Pound Cake is recalled due to undeclared Yellow #5, Yellow #6, and Red #40 artificial colorants. Affected product was distributed to Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
Volkswagen is recalling certain 2022 Taos vehicles with all-wheel drive due to engine control unit software that may cause engine stall when coming to a stop, increasing crash risk. Dealers will provide free software updates.
Piantedosi Baking Co. is recalling frozen Gourmet Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 units across 15 states.
Piantedosi Baking Co. is recalling 18,119 frozen Brioche-Style Slider Roll 24-packs distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Biosense Webster is recalling 98 units of CARTO VIZIGO 8.5F guiding sheaths due to water damage to packaging that may have compromised the sterile barrier, creating a potential infection risk.
Select Bakery Gourmet Banana Nut Pound Cake contains undeclared soy, posing a risk to consumers with soy allergies. The product was distributed in Georgia, North Carolina, and South Carolina.
Datascope Corporation is recalling 10,427 units of the MEGA 8Fr 50cc Intra-Aortic Balloon Catheter due to an undersized dilator in certain lots. The device has been distributed internationally and is awaiting domestic distribution.
Piantedosi Baking Co. is recalling Brioche Style Burger Rolls (UPC 033474504170) distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Piantedosi Baking Co. is recalling frozen Gourmet Potato Slider Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 18,119 product trays were distributed across 15 states.
Plastikon Healthcare LLC is recalling guaifenesin and dextromethorphan liquid medication (280,500 cups) distributed nationwide due to manufacturing control deviations in production.
American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.
CORRECTDOSE Children's Allergy Relief (Diphenhydramine HCl 12.5 mg per 5 mL) is being recalled nationwide. The FDA determined products were manufactured under conditions with inadequate process control.
Select Bakery Peanut Butter DELIGHT (3 oz packages) is recalled because it contains undeclared soy and Red #40. The product was distributed to Georgia, North Carolina, and South Carolina.
Acetaminophen Oral Solution 160 mg/5 mL (290,270 cups) recalled nationwide due to CGMP manufacturing control deviations. Product was distributed to institutional healthcare facilities.
Saranas, Inc. is recalling 953 units of the Early Bird Bleed Monitoring System Introducer Sheath Set due to a design error that prevents the device from powering on and completing self-tests. The product was distributed nationwide.
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
Piantedosi Baking Co. is recalling 18,119 trays of frozen finger rolls distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Plastikon Healthcare recalls 49,280 cups of Calcium Carbonate Oral Suspension (1250 mg/5 mL) distributed nationwide due to manufacturing process control failures during production.
B & W Gourmet Burger Rolls are being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across 15 states.
Piantedosi Baking Co. is recalling Split Top Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across multiple northeastern and southeastern states.
Select Bakery Gourmet Blueberry Pound Cake (5 oz) is recalled due to undeclared soy and food colorings. The product was distributed in Georgia, North Carolina, and South Carolina.
MERCHSOURCE LLC is recalling a handheld ultraviolet-C germicidal wand (model 1013622) due to excessive ultraviolet-C radiation emission. Consumers should stop using the product immediately.
American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.
Piantedosi Baking Co. is recalling Slider Rolls No Seeds 24-pack due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 18,119 units distributed across 15 states.
Select Bakery Gourmet Old Fashion Pound Cake (5 oz) is being recalled due to undeclared soy allergen and artificial food dyes (Yellow #5, Yellow #6, Red #40). The product was distributed in Georgia, North Carolina, and South Carolina.
Datascope Corporation recalls certain lots of Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheters due to undersized dilators. The manufacturing defect affects approximately 10,427 units distributed internationally and awaiting U.S. distribution.
The VITROS XT 7600 laboratory analyzer may report inaccurate test results when the system performs a shutdown. The issue affects approximately 1,148 units distributed worldwide.
The VITROS XT 3400 Chemistry System may produce inaccurate test results during shutdown due to electrical current shifts. The FDA has classified this Class II recall, affecting 506 units distributed worldwide.
American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.
Select Bakery is recalling Gourmet Lemon Pound Cake due to undeclared soy and artificial color additives (Yellow #6, Red #40). The product was distributed in Georgia, North Carolina, and South Carolina.
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
BALT USA recalls the Optima Coil System because devices were distributed with material from an alternate supplier before required testing was approved. No illnesses or injuries have been reported.
Piantedosi Baking Co. is recalling Gourmet Junior Burger Roll 12-packs distributed across 15 states due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.
American Contract Systems is recalling 39 laparoscopy instrument packs that were exposed to multiple sterilization cycles without validation. The sterilization process was not tested for repeated exposures.
American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.
Medline Industries is recalling Chest Tube Convenience Kits due to non-sterile tape included in the sterile portion of the kit, creating a contamination and infection risk.
Piantedosi Baking Co. is recalling Hawaiian Sandwich Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed across multiple states.
Ford is recalling certain 2022 Ranger and Explorer models with 2.3L engines due to potentially loose fuel line connections. An improperly tightened connection may result in a fuel leak, increasing the risk of fire.
American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.
Piantedosi Baking Co., Inc. is recalling Gourmet Potato Deli Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 18,119 frozen trays were distributed to consumers.
Plastikon Healthcare LLC is recalling 502,600 cups of Milk of Magnesia USP due to manufacturing process control deviations. Consumers should discontinue use and consult their healthcare provider if concerned.
Select Bakery's 3-oz Orange Creme Cake is recalled for undeclared soy. The product was voluntarily recalled and distributed to Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
Plastikon Healthcare LLC is recalling Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
Select Bakery has recalled its Old Fashion Chocolate Creme Cake for containing undeclared soy. The recall affects products distributed in Georgia, North Carolina, and South Carolina.
Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution nationwide because manufacturing quality controls were not adequately maintained. Affected product was distributed to institutional healthcare settings.
Kent Precision Foods Group is recalling Thick-It Original Food & Beverage Thickener due to possible insanitary conditions during manufacturing. The product was distributed to food service facilities including hospitals and nursing homes.
Plastikon Healthcare LLC is recalling multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
BMW is recalling one 2022 745E hybrid vehicle because an improperly sized battery cell electrode may cause a short-circuit and increase the risk of fire.
Mercedes-Benz is recalling 2021 GLB 250 vehicles because a damaged Electronic Stability Program unit may cause an electrical short circuit, increasing the risk of fire.
Daimler Trucks North America is recalling 2022-2023 Western Star 47X and 49X commercial trucks because the steering shaft's u-joint pinch bolt may detach, causing loss of steering control.
Mercedes-Benz is recalling 2022 C 300 vehicles because moisture in the trunk may cause an electrical short in the signal acquisition module, increasing the risk of fire or crash.
Farber Specialty Vehicles is recalling one 2021 Freightliner XC because an incorrectly installed resistor can cause vehicle lighting to fail, increasing crash risk.
Mercedes-Benz is recalling certain 2020-2022 GLE and GLS models because rear door window trim bars may detach, creating a road hazard.
Spartan Fire is recalling 2022 Gladiator and MetroStar fire trucks because the front wheel parking brake may not engage, increasing crash risk.
USDA FSIS issued a public health alert for specific HelloFresh ground beef packages linked to an E. coli O157:H7 outbreak. Consumers are urged to discard the product.
Murphy beds sold under Ivy Bronx, Orren Ellis, Stellar Home Furniture, and Wade Logan brand names can break or detach from walls and fall, posing crush and impact hazards. The manufacturer has received 146 reports of failures with 62 injuries.
Ford is recalling 2022 F-150 Raptor Series vehicles with 37-inch tires because incorrectly tightened wheel lug nuts may loosen, increasing the risk of wheel separation and a crash.
BMW is recalling 2022 CE 04 motorcycles because the horn may loosen or detach, potentially interfering with steering and increasing crash risk.
Audi is recalling certain 2022 and 2021 Q3 vehicles due to a damaged vent pipe in the fuel tank that may allow gasoline to spill when the fuel cap is opened, increasing the risk of injury.
Terex is recalling 2019-2022 TL80, TL80/112, and TL100 aerial devices because weld cracks may cause the platform to tip, increasing injury risk.
Hearing Lab Technology/Lucid Audio is recalling approximately 31,150 Children's HearMuffs sound compression ear muffs because the AAA alkaline batteries included can rupture, posing hearing, projectile, and burn injury risks. No injuries have been reported.
About 7,700 Tethrd One Stick GEN 2 climbing sticks are being recalled because their steps can crack and break under pressure, creating fall and injury hazards. The manufacturer has received five reports of step breakage but no injuries have been reported.
LEM Products Distribution is recalling about 15,900 Roots & Harvest Wide Mouth Pint Canning Jars because pieces of glass may be found inside, posing a laceration hazard. No injuries have been reported.
Lyons Magnus is recalling Lyons Ready Care Plant-Based Protein Shake Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum, serious bacterial pathogens that can cause illness.
Lyons Magnus recalls Lyons Ready Care 2.0 Chocolate Nutritional Drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected units have lot codes 8212 and 9302.
Supherb Farms is recalling IQF Fresh Frozen Dill nationwide and in Canada after testing detected Listeria Monocytogenes in the product. The recall affects approximately 25,009 pounds distributed in 35-pound bulk cases.
Sweetie Pie Organics Lactation Smoothie is recalled nationwide due to contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.
Sweetie Pie Organics Lactation Smoothie Mango Banana is recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 53,818,025 units distributed nationwide.
Lyons Magnus is recalling Kate Farms Nutrition Shake, Chocolate nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.
Premier Protein Vanilla High Protein Shake is recalled due to findings and potential for Cronobacter sakazakii and Clostridium botulinum in a nationwide distribution of 53,818,025 units.
Lyons Magnus is recalling pirq Plant Protein Super Foods Very Strawberry Drink nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Approximately 53.8 million units are affected in this Class I recall.
Sysco Imperial Med Plus 2.0 nutritional drink is recalled nationwide for potential contamination with Cronobacter sakazakii and Clostridium botulinum. The FDA classified this as Class I.
Stumptown Cold Brew Coffee with Oatmilk Original is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. This FDA Class I recall affects approximately 53.8 million units.
Lyons Magnus recalls Artisan Glaze, a food ingredient, due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The product was distributed nationwide with best-by dates from November to December 2022.
Lyons Magnus is recalling MRE Vanilla Protein Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Lyons Magnus is recalling Barista Style Coconut, a plant-based milk beverage, nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
Lyons Magnus recalls MRE Salted Caramel Protein Shake nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products.
Lyons Magnus is recalling Organic Valley 1% lowfat milk nationwide due to Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the affected product.
Lyons Magnus is recalling Lyons Barista Style Soy Non-Dairy Beverage nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination affecting over 53 million units.
Lyons Magnus is recalling Oatly Oat-Milk Barista Edition (11 fl oz) nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.
Kate Farms Standard 1.4 Cal/mL nutrition formula in 325 mL bottles is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum. Affected lot code 8031 has best-by date November 4, 2022.
Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink has been recalled nationwide due to findings and potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.
Premier Nutrition is recalling Premier Protein Cafe Latte shakes distributed nationwide due to contamination findings with Cronobacter sakazakii and Clostridium botulinum bacteria. Over 53 million units are affected.
Wegmans Lemon Dill Finishing Butter is being recalled due to potential Listeria monocytogenes contamination from the frozen dill ingredient. The recall affects 1,137 cases distributed to Wegmans stores in eight states and Washington, DC.
Lyons Magnus recalls Rejuvenate Muscle Health+ Vanilla nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.
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