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
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.
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.
Plastikon Healthcare LLC is recalling acetaminophen oral solution (650 mg per 20.3 mL cup) distributed nationwide due to manufacturing process control failures.
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.
Akorn, Inc. is recalling Sodium Chloride Ophthalmic Ointment due to turbidity found during sterility testing. The FDA expanded the recall to additional lots sharing potential root cause.
Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.
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.
Plastikon Healthcare LLC is recalling Guaifenesin and Dextromethorphan cough syrup cups distributed nationwide due to manufacturing processes that were not adequately controlled.
American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.
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.
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.
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.
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.
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.
American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.
ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.
American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.
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.
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.
American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.
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.
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.
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.
Abbott is recalling 579 kits of its Alinity m SARS-CoV-2 CTRL control kit after reports of failed internal control errors preventing verification of test accuracy.
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.
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.
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 is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.
Piantedosi Baking Co., Inc. is recalling Clustered Potato Burger Rolls due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects products distributed across 15 states.
Pepsico Inc is recalling Starbucks Vanilla Espresso Triple Shot beverages due to possible contamination with metal fragments.
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.
Select Bakery is recalling Old Fashion Walnut Creme Cake because it contains undeclared soy and sulfites not listed on the label. People with allergies to soy or sulfites should not consume this product.
Select Bakery Old Fashion Strawberry Creme Cake is being recalled due to undeclared soy. The affected product was distributed in Georgia, North Carolina, and South Carolina.
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.
Select Bakery Walnut Brownies are being recalled due to undeclared soy and Red #40. The product was distributed in Georgia, North Carolina, and South Carolina.
CORRECTDOSE Children's Fever Reducer (160 mg/5 mL acetaminophen) has been recalled due to manufacturing control deviations. The recall affects 1,464 units distributed nationwide.
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.
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.
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.
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.
Plastikon Healthcare LLC is recalling Diphenhydramine HCl Oral Solution nationwide due to manufacturing control deficiencies that did not meet Current Good Manufacturing Practice standards.
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.
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.
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.
CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.
ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.
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.
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.
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.
American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.
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.
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.
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.
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.
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 Milk of Magnesia USP due to manufacturing process control deviations affecting approximately 92,200 cups distributed nationwide.
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.
Plastikon Healthcare LLC is recalling an antacid oral suspension due to manufacturing control deviations. No illnesses have been reported.
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 multiple lots of antacid suspension because manufacturing processes were not adequately controlled. The product was distributed nationwide to institutions.
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.
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 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.
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 2021 GLB 250 vehicles because a damaged Electronic Stability Program unit may cause an electrical short circuit, increasing the risk of fire.
Spartan Fire is recalling 2022 Gladiator and MetroStar fire trucks because the front wheel parking brake may not engage, increasing crash risk.
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.
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.
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.
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.
Terex is recalling 2019-2022 TL80, TL80/112, and TL100 aerial devices because weld cracks may cause the platform to tip, increasing injury risk.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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 is recalling Kate Farms Nutrition Shake, Chocolate nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.
Sweetie Pie Organics Lactation Smoothie is recalled nationwide due to contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.
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 is recalling Barista Style Coconut, a plant-based milk beverage, nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.
Lyons Magnus recalls Aloha Organic Protein Drink nationwide due to Cronobacter sakazakii and Clostridium botulinum contamination. The FDA Class I recall affects 53,818,025 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 approximately 53.8 million units of MRE Milk Chocolate Protein Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
Lyons Magnus is recalling nationwide its Lyons Ready Care Plant-Based Protein Shake due to findings of and potential for Cronobacter sakazakii and Clostridium botulinum contamination. Affected lot codes are 5221 (08/08/2022) and 6221 (08/09/2022).
Lyons Magnus recalls 53,818,025 units of Golden Gloss vegetable protein due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The product was distributed nationwide.
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 Pediatric Standard Sole-Source Nutrition Formula is recalled nationwide due to findings of potential Cronobacter sakazakii and Clostridium botulinum contamination.
Lyons Magnus recalls Sysco Imperial Thickened Dairy Drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.
Oatly Original Oat-Milk is being recalled nationwide due to potential findings of Cronobacter sakazakii and Clostridium botulinum contamination. Approximately 53.8 million units are affected.
Lyons Magnus is recalling Glucerna original Vanilla Shake due to findings of Cronobacter sakazakii and potential Clostridium botulinum. Over 53 million units were distributed nationwide.
Lyons Magnus is recalling Barista Style Sweet Cream Frappe Base nationwide due to findings of and potential for Cronobacter sakazakii and Clostridium botulinum.
Lyons Magnus is recalling Lyons Barista Style Oat, a plant-based milk beverage distributed nationwide, due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.
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