Archive
857 recalls were announced in June 2022.
Of the 857 recalls this month scored against our rubric, 3% are Critical, 27% are Severe.
Which agencies issued them
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
Natural Organics, Inc. is recalling 4,650 bottles of Keto Living Sugar Control nationwide and internationally due to undeclared wheat in a product labeled gluten-free. Consumers with wheat allergies or celiac disease should not use this product.
Nephron Sterile Compounding Center LLC is recalling succinylcholine chloride injection due to lack of sterility assurance. The recall involves 181,560 pre-filled syringes distributed nationwide.
Dymski Pierogi LLC is recalling potato and cheese pierogi products due to undeclared milk and wheat allergens. Affected products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.
DYMSKI PIEROGI LLC is recalling Mini Potato-Cheddar Pierogi due to the presence of undeclared milk. Individuals with milk allergies may be affected by this product.
Walnut Creek Chocolate Co Inc is recalling Jason & Mary Large Dark Peanut Butter Cups due to potential Salmonella contamination affecting 4740 units across 30 states.
Dawson Food Products is recalling Belgian Style Waffle Mix that tested positive for E. coli at low levels. Consumers should not consume the affected product.
Baxter Healthcare Corporation is recalling 510 units of 15-liter peritoneal dialysis drain bags that were distributed without required FDA regulatory clearance.
Dymski Pierogi LLC is recalling Potato & American Cheese Pierogi products because they contain undeclared milk. The recall affects products distributed in New Jersey, Massachusetts, and Pennsylvania.
Keystone Coachworks is recalling 2020-2021 Mercedes-Benz Metris Custom Camper Vans because damaged burner control valves may cause a gas leak, increasing fire risk.
DYMSKI PIEROGI LLC is recalling spinach-feta pierogis (865 units) because they contain undeclared milk, a common allergen not disclosed on labels. Products were distributed to retail stores, restaurants, and distribution centers in NJ, MA, and PA.
Grandma's Cuisine Potato-Cheddar-Jalapeno Pierogi is recalled for containing undeclared milk, an allergen. The product was distributed to retailers and restaurants in New Jersey, Massachusetts, and Pennsylvania.
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.
Nephron Sterile Compounding Center is recalling Ketamine Hydrochloride Injection due to lack of assurance of sterility. The recall affects 107,530 pre-filled syringes distributed nationwide.
Strides Pharma Inc. is recalling Losartan Potassium 50 mg tablets distributed nationwide due to AZIDO impurity levels exceeding acceptable FDA manufacturing standards.
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
Intuitive Surgical recalls da Vinci Energy SynchroSeal surgical instruments due to potential seal failure. Excessive tissue in the instrument jaws can result in insufficient sealing.
Nephron Sterile Compounding Center is recalling 35,850 pre-filled syringes of EPINEPHrine Injection due to lack of sterility assurance. The affected syringes were distributed nationwide.
Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
Strides Pharma Inc. is recalling Losartan Potassium 100 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Patients should contact their healthcare provider to verify if they are affected.
Nephron Sterile Compounding Center recalls glycopyrrolate injection (1 mg/5 mL, preservative-free) due to lack of assurance of sterility. Approximately 32,550 pre-filled syringes from lot GL2002B have been distributed nationwide.
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection 50 mg/50 mL pre-filled syringes due to lack of sterility assurance. The recalled product was distributed nationwide.
Busse Hospital Disposables is recalling 3.2MM Pellet Insertion Trays due to inadequate validation of manufacturing test methods. The recall affects 150 units distributed nationwide.
Becton Dickinson is recalling 199 units of BD Anti-Kappa PE flow cytometry reagent because samples may exhibit uncharacteristic flow profiles that could affect test accuracy.
Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.
Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.
Busse Hospital Disposables recalls approximately 425 units of its Single Shot Epidural Tray nationwide due to inadequate validation of manufacturing test methods for swab components.
Dymski Pierogi LLC is recalling Cheese & Scallion Pierogi (Grandma's Cuisine brand) due to undeclared milk. The product was distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.
Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.
Busse Hospital Disposables is recalling Pellet Insertion Tray Kits due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were distributed nationwide.
Dynex Technologies is recalling the DYNEX Agility Analyzer (Model 67000) due to a software defect that could cause control samples from the wrong SmartKit to be used during testing, potentially leading to delayed patient results.
Busse Hospital Disposables is recalling convenience kits containing swab and swabstick products due to uncertainty regarding the adequacy of manufacturing test method validation. Affected lot numbers are 2110127 and 2110269.
Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
Busse Hospital Disposables is recalling its SS 4.5MM Pellet Insertion Tray nationwide due to uncertainty regarding the adequacy of the validation of the manufacturing test methods used.
Busse Hospital Disposables recalls Single Shot Epidural Tray kits due to uncertainty about the adequacy of test method validation in manufacturing. No illnesses reported.
Nephron Sterile Compounding Center is recalling 30,180 pre-filled Calcium Gluconate Injection syringes due to lack of sterility assurance. Affected lots CG1003A and CG2001A were distributed nationwide.
Karben4 Brewing LLC is recalling Wisco Pop Strawberry Soda because cans may contain yeast. The product was distributed in Illinois, Minnesota, and Wisconsin.
TWISTED BRANDS LLC is recalling Cosmic Crunch Bites By Twisted Delta 8 edibles due to undeclared soy lecithin and coconut oil, which may pose a serious allergy risk to consumers with these allergies.
Ardent Mills is recalling BBU Fine Whole Wheat Flour and SG Whole Wheat Fine Flour due to potential contamination with small pieces of stainless steel from milling equipment discovered during inspection.
Wegmans Food You Feel Good About Lobster Bisque is being recalled because its HACCP food safety plan was not fully implemented. No illnesses have been reported.
Dymski Pierogi LLC recalled 836 units of Potato-Cheddar-Broccoli Pierogi products due to undeclared milk allergen. Products were distributed to retail stores and restaurants in New Jersey, Massachusetts, and Pennsylvania.
Dymski Pierogi LLC is recalling Sweet Cheese Pierogi products with undeclared milk and wheat allergens. Approximately 1,721 units were distributed to retail and food service locations in NJ, MA, and PA.
DYMSKI PIEROGI LLC is recalling Potato & Cheddar Cheese Pierogi products sold in NJ, MA, and PA because they contain undeclared milk and wheat allergens. Consumers with allergies to milk or wheat should not consume these products.
Walnut Creek Chocolate Co Inc is recalling Peanut Butter Fudge packaged in 8-ounce tubs, 5-pound loaves, and 4-pound trays due to potential Salmonella contamination. The recalled products were distributed to 29 states.
Cherry Coca-Cola Zero Sugar in 12 oz cans were mislabeled as regular Cherry Coca-Cola and failed to declare phenylalanine on the label, a concern for people with phenylketonuria.
Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes distributed nationwide.
Nephron Sterile Compounding Center recalled Lidocaine HCl Injection due to lack of sterility assurance. The recalled lot affects 65,590 pre-filled syringes distributed nationwide.
Nephron Sterile Compounding Center is recalling approximately 13,612 units of 8.4% Sodium Bicarbonate Injection due to lack of assurance of sterility. The product was distributed nationwide.
Direct Rx is recalling 81 bottles of Losartan Potassium and Hydrochlorothiazide 100/12.5 mg due to AZIDO impurity exceeding acceptable manufacturing standards. Affected bottles were distributed in Alabama, Georgia, Florida, and Louisiana.
Nephron Sterile Compounding Center has recalled 115,640 units of Labetalol HCl Injection due to lack of assurance of sterility. The affected product was distributed nationwide.
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection pre-filled syringes nationwide due to lack of sterility assurance. Approximately 604,080 syringes are affected.
Nephron Sterile Compounding Center has recalled 3,587 bags of Oxytocin injectable nationwide due to lack of assurance of sterility.
AMBI Skincare Fade Cream is being recalled nationwide due to cGMP violations. The product was stored outside its labeled temperature requirements during manufacturing.
Walmart is recalling Equate Tartar Control Plus mouthwash from certain lots because they were found to have active ingredients outside the approved specification.
The Proteus235 Proton Therapy System may deliver radiation to initial treatment fields with incorrect scanning magnet settings. The radiation field may be smaller than expected and may deliver higher dose than prescribed.
Busse Hospital Disposables is recalling Nerve Block Trays containing swab and swabstick products due to uncertainty about manufacturing test method validation. Affected lot numbers should be discontinued.
Busse Hospital Disposables recalled Nerve Block Tray units (catalog #8415) containing swab components due to uncertainty about adequate test method validation. The recall affects 420 units distributed nationwide.
Baxter Healthcare is recalling in-line ventilator adaptors (Optimus Handset 2 module) used in home care. The devices may cause reduced oxygenation or barotrauma when used with Volara systems.
Busse Hospital Disposables is recalling Nerve Block Tray kits containing swab drug products due to uncertainty regarding adequate validation of test methods during manufacturing. The recall involves 250 units distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are recalled due to uncertainty about manufacturing test method validation.
MEDLINE is recalling certain lots of its Polyurethane Bedside Cleaning Kits due to confirmed microbial contamination on the foam sponge. The kits were distributed in the US and Panama.
Busse Hospital Disposables is recalling Sterile Epidural Trays nationwide due to uncertainty about whether test method validation was adequate. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.
Busse Hospital Disposables is recalling Single Shot Epidural Trays because swab components from Professional Disposables International were manufactured with unvalidated test methods.
Tornier's Ratcheting Screwdriver Handle in the Aequalis Perform Reversed kit cannot meet sterilization requirements when sterilized per instructions in an Aesculap container. The company is recalling 1066 units distributed nationwide.
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled due to uncertainty regarding the adequacy of manufacturing test method validation.
Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.
XVIVO Perfusion AB is recalling the XVIVO Organ Chamber REF 19020 due to an incomplete weld seal on the primary pouch that prevents sterility assurance. Approximately 80 devices were distributed in the U.S. and internationally.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab/swabstick drug products due to uncertainty about the adequacy of manufacturing test method validation.
Bio-Rad is recalling Resin Update CD-ROM software (Model 250-3020) for the VARIANT nbs Sickle Cell Program because the update procedure overwrites custom laboratory settings, potentially causing incorrect pattern assignment in tested samples.
Busse Hospital Disposables is recalling Single Shot Epidural Trays due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.
Busse Hospital Disposables is recalling Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.
Baxter Healthcare is recalling locking caps for peritoneal dialysis catheters that were distributed without FDA regulatory clearance. These devices were released into the U.S. market in error.
Busse Hospital Disposables is recalling convenience kits containing swab products due to uncertainty about adequate validation of manufacturing test methods.
Busse Hospital Disposables is recalling Procedure Tray Catalog 1065 nationwide due to uncertain validation of manufacturing test methods for the swab/swabstick drug products inside.
Karben4 Brewing LLC is recalling specific lots of Wisco Pop Ginger Soda because cans may contain yeast. The recall affects products distributed in Illinois, Minnesota, and Wisconsin.
AMBI Skincare Fade Cream Oily Skin (2 OZ) is recalled nationwide due to improper storage temperature. The product was stored outside the temperature requirements specified on its label.
Family Dollar is recalling an AMBI Skincare Even & Clear Nourishing Daily Facial Moisturizer (SPF 30) for improper storage. The product may have reduced efficacy.
Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer due to storage outside of labeled temperature requirements, which may affect product efficacy.
Family Dollar Stores is recalling Luxury Hygiene Hand Sanitizer Moisturizing Formula due to cGMP deviations related to improper storage outside labeled temperature requirements.
Family Dollar Stores is recalling AMBI Skincare Even & Clear Exfoliating Wash because the product was stored outside labeled temperature requirements during manufacturing. No illnesses have been reported.
Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.
Busse Hospital Disposables is recalling Convenience kits containing swab/swabstick drug products due to uncertainty about the validation of manufacturing test methods. The FDA classified this as a Class II recall.
Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.
MEDLINE has recalled its Polyurethane Foam Bedside Cleaning Kit (REF DYK500FS) in the United States and Panama after sporadic reports of discoloration. The discoloration has been identified as microbial contamination.
Busse Convenience kits containing swab and swabstick drug products manufactured by PDI are recalled due to uncertainty about manufacturing test method validation. No illnesses have been reported.
Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.
Busse Hospital Disposables recalls Universal Nerve Block Trays and swab products manufactured by PDI due to uncertainty regarding manufacturing test method validation.
Busse Convenience kits containing medical swabs and sticks have been recalled due to uncertainty about whether the manufacturing test methods used were adequately validated.
Medtronic Xomed is recalling 18 units of the NIM Vital Console 4.0 surgical nerve monitoring device due to an identified software anomaly. Distribution was confirmed in Texas, Colorado, New Jersey, and France.
Looking for a different month? Back to 2022.