689 recalls tagged with “fda regulated”.
Fresenius Kabi Compounding recalled 1,578 bags of vancomycin HCl injection on February 5, 2026. The company cited a lack of assurance of sterility as the reason for the recall. Healthcare providers and consumers should stop using the product immediately.
Fresenius Kabi Compounding recalled 1,410 bags of ketamine HCl injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers and consumers must stop using this product immediately.
Fresenius Kabi Compounding recalled 10,548 bags of thiamine HCl injection on February 5, 2026. The recall follows a lack of assurance of sterility, posing a high health risk. Affected products include several lots expiring between February and May 2026.
Fresenius Kabi Compounding recalled 1,057 bags of Acyclovir Sodium Injection on February 5, 2026. The recall stems from a lack of assurance of sterility, posing a high health risk. Healthcare providers should cease use immediately and contact the manufacturer for guidance.
Remel, Inc. recalled 97 units of Campy CVA Medium on February 5, 2026. Customers reported low to no recovery of Campylobacter Jejuni ATCC 33291 in the affected lot. Healthcare providers and patients must stop using the product immediately.
Fresenius Kabi Compounding recalled its vancomycin HCl injection on February 5, 2026, due to a lack of assurance of sterility. This Class II recall affects all lots distributed nationwide. Healthcare providers and consumers must stop using the product immediately.
Prime Food Processing recalled 79 cases of dried croaker fish on February 3, 2026, due to safety concerns. The uneviscerated fish poses a high risk of food poisoning. Consumers should not consume this product and seek refunds.
GE Medical Systems recalled 125 Imactis CT-Navigation System stereotaxic accessories distributed worldwide to healthcare facilities. The recall cites a potential mismatch between the simulated needle trajectory and the actual trajectory. Healthcare providers should stop using the devices immediately and follow the manufacturer's recall instructions.
B. Braun Medical is recalling 21,000 21GA Winged Infusion Sets (Single Pack) distributed worldwide, including Texas and Costa Rica, catalog 7A3842. The needle tip can be dull or blunt, may be difficult to advance, or break. Clinicians and patients should stop using the device and await manufacturer instructions.
B. Braun Medical recalled 105,550 BBraun Medical 21G X4.4CM Winged INF devices worldwide, including Texas and Costa Rica. A dull or blunt needle tip may be difficult to advance or break. Healthcare providers and patients should stop using the device and follow the manufacturer's recall instructions.
Tandem Diabetes Care recalled 1,380 insulin infusion pumps distributed internationally in the Czech Republic and Slovakia after translation errors in the Czech user guide could cause unintended insulin delivery. The most significant error told users to verify the infusion set is connected to the body when it should be confirming it is not connected. Following this instruction could result in a hyp
Medtronic MiniMed recalled 26,851 MiniMed 780G insulin pumps sold worldwide, including the United States and Israel. Three software defects tied to updates 6.60, 6.61, and 6.62 could misdose insulin. Stop using the affected pumps and follow the recall letter for instructions.
ReCor Medical Inc. has issued an active recall for 24 Paradise ultrasound renal denervation catheters distributed nationwide in nine states. The devices were nonconforming and were supposed to be scrapped and not for human use. Healthcare providers and patients should stop using the devices immediately and await manufacturer recall instructions.
Paradise Renal Denervation Catheter was recalled after a single unit distributed nationwide in nine states was deemed nonconforming and not for human use. The device is an ultrasound renal denervation catheter. Healthcare providers should stop using it and contact ReCor Medical for instructions.
Teva Pharmaceuticals recalled 19,056 bottles of Metoprolol Succinate Extended-Release Tablets, 200 mg, sold nationwide. The recall cites failed dissolution specifications, which could affect how the drug releases in the body. Patients should stop using the product and contact Teva or their healthcare provider for guidance.
Olympus Corporation of the Americas recalls 1,276 boxes of MAJ-1218 Single Use Biopsy Valve distributed nationwide to healthcare facilities. The device risks rubber fragment detachment during use. Stop using the device and follow the recall instructions from Olympus or your healthcare provider.
Teva Pharmaceuticals recalled 67,043 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide. The FDA enforcement report cites Failed Dissolution Specifications as the hazard. Health care providers and patients should stop using this product immediately and contact Teva for guidance.
Teva Pharmaceuticals recalled 7,448 bottles of Metoprolol Succinate Extended-Release Tablets nationwide after failed dissolution specifications were identified. The recall involves 100 mg, 100‑tablet bottles (NDC 45963-677-11) and 1,000‑tablet bottles (NDC 45963-677-96). The defect may affect drug release and efficacy. Patients should stop using affected bottles and contact Teva or their clinician
Ultradent Products recalled 2,508 Jiffy Original Composite Polisher Cups (Coarse) 12pk across multiple U.S. states. A defect causes cups to crumble and break apart, potentially delaying patient treatment. Clinicians should stop using the cups immediately and follow the manufacturer’s recall instructions.
Abiomed recalled 4,496 Impella RP Flex with SmartAssist devices. The recall cites a differential pressure sensor that may malfunction and drift readings. Stop using the device immediately and follow the manufacturer's recall instructions.