1,320 recalls tagged with “fda regulated”.
DJO recalled 1,594 Cold Form Wraps for back and shoulder use nationwide through multiple retailers. The IFU directs heating in a microwave for 3 minutes, which can cause leaks or seam breaks and temperatures high enough to cause a second-degree burn. Stop using the device and follow the manufacturer’s recall instructions.
Georgia Nut Co recalls 76,121 cases of tru fru Strawberries + Creme Freeze-Dried Fresh 3.4 oz pouches sold nationwide at retailers including Albertsons, CVS, Food Lion, H-E-B, Kroger, Target, Stew Leonard's and more. A potential for metal fragments in some packages is the hazard. Consumers should stop using the product and contact Georgia Nut Co for a refund or replacement.
Georgia Nut Co recalls 170,993 cases of tru fru Dark + White Chocolate Freeze-Dried Strawberries sold nationwide after metal fragments were detected. The recall covers 1.7oz, 3.4oz, and 13oz pouches with UPCs 850048358331, 850048358270, and 850048358379 and distributions to major retailers including Albertsons, CVS, Kroger and Target. Consumers should not eat the product and should await a recall‑
Aloe Up recalled 11,386 tubes of Aloe Up Sport Performance Sunscreen Lotion SPF 30 sold nationwide in the United States. The recall cites cGMP deviations after the product failed total aerobic microbial count testing. Consumers should stop using the product and follow guidance from SV Labs Prescott Corporation or a healthcare provider.
Zydus Lifesciences and Zydus Pharmaceuticals USA recall 600 bottles of Entacavir 1 mg tablets distributed nationwide in the United States. An out-of-specification organic impurity triggered the recall. Stop use immediately and contact a healthcare provider or Zydus for guidance.
Southwind Foods LLC dba Great American Seafood Imports Co. expanded recall covers Arctic Shores, Best Yet, Great American and Master Catch frozen shrimp sold nationwide by multiple retailers after Cesium-137 contamination was detected. The contaminated product was manufactured under insanitary conditions. Consumers should not eat the product and should contact the company for refunds or replaced.
BD recalled 4,283 Phoenix M50 Automated Microbiology Systems worldwide after unauthorized access to product service credentials. The unauthorized actor could access affected products and data. Labs should stop using these devices and follow the recall instructions from BD; contact BD for remediation guidance.
Arctic Shores recalled 93,122 cases of Frozen cooked salad shrimp in 6 oz bags. The recall affects products distributed to 26 states. The product may be contaminated with Cesium-137 due to insanitary manufacturing conditions. Consumers should not eat this product and should contact Southwind Foods LLC dba Great American Seafood Imports for refund or replacement information.
Southwind Foods LLC, doing business as Great American Seafood Imports, recalled 93,122 cases of Tovala-brand frozen raw phosphate-free shrimp after identifying potential Cesium-137 contamination. The recall expands a prior action and notes insanitary production conditions. Consumers who bought the 5 oz IQF bag with UPC 829944085788 should not eat it and should contact the supplier for refund or re
BD recalled 2,050 units of the EpiCenter Microbiology Data Management System due to unauthorized access to product service credentials. The defect could allow access to confidential data. Stop using affected devices and follow manufacturer guidance for updates or replacement.
DEMERS FOOD GROUP recalled 966 cases of Scott & Jon's Honey Sesame Salmon Rice Bowl distributed across nine states. The undeclared wheat allergen could trigger a reaction in wheat-allergic individuals. Consumers should not eat this product and should contact DEMERS FOOD GROUP for refunds or replacements.
BD recalled 1,086 BD BACTEC Blood Culture System units worldwide after unauthorized access to product service credentials. The breach could compromise confidentiality, integrity and availability of affected devices and data. Hospitals and healthcare providers should stop using the device immediately and follow BD’s recall instructions.
BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’s recall instructions.
RC Outsourcing recalled 2,669 bevacizumab intravitreal syringes distributed nationwide to hospitals and clinics. The recall cites a lack of assurance of sterility. Stop using the product immediately and contact RC Outsourcing or your healthcare provider for guidance. Recall notices will be sent by letter.
Black Sheep Egg Company recalled 20,625 dozen eggs sold at retail and wholesale locations in Arkansas and Missouri after a potential Salmonella contamination. The eggs are Free Range Grade AA Large Brown, loose-packed in boxes. Consumers should not consume these eggs and should contact Black Sheep Egg Company for refunds or replacements.
Beckman Coulter recalls 160 DxC 500i Clinical Analyzer Modules and the DxI 9000 Access Immunoassay Analyzer worldwide after a software anomaly could misapply manual dilution factors. The defect affects samples already in progress using the same Sample ID. Stop using the devices immediately and follow the recall instructions. Beckman Coulter will provide instructions via the recall process.
Kico Knee Innovation recalls 21 ARVIS Shoulder systems nationwide after reports that AI planning software may cause implant malalignment or reduced range of motion. The recall covers software version V2025.1.2 used with IN-27300 hardware. Healthcare providers and patients should stop using the device and follow manufacturer instructions.
Ascend Laboratories recalls Atorvastatin Calcium Tablets USP, 80 mg, in 90-count and 500-count packages nationwide. The recall cites failed dissolution specifications. Health care providers and patients should stop using the recalled tablets and seek guidance from Ascend or their prescribers.
Black Sheep Egg Company recalled 23,400 dozen Free Range Grade AA Large White Eggs sold at retail and wholesale locations in Arkansas and Missouri due to potential Salmonella contamination. Consumers should not eat these eggs. Contact Black Sheep Egg Company, LLC for refund or replacement information.
Ascend Laboratories recalled Atorvastatin Calcium Tablets USP 40 mg, 90-count (NDC 67877-513-90), 500-count (NDC 67877-513-05), and 1,000-count (NDC 67877-513-10) nationwide in the United States. The batches failed dissolution specifications. Patients should stop using the medication and contact Ascend Laboratories, LLC or their healthcare provider for guidance.