1,264 recalls tagged with “fda regulated”.
Baxter Healthcare recalled 136,512 CLEARLINK System Solution Set DUO-VENT IV sets distributed nationwide in the United States after detecting a leak risk. The Luer Activated Valve design may leak, potentially compromising IV administration. Hospitals and patients should stop using the device immediately and follow Baxter recall instructions.
Baxter Healthcare recalled 69,936 CLEARLINK System Non_DEHP Extension Sets sold nationwide to hospitals and clinics. The IV extension sets may leak. Healthcare providers should stop using the device and follow Baxter's recall instructions.
Baxter Healthcare recalled 27,072 CLEARLINK System Paclitaxel IV Sets distributed nationwide in the United States. The units may leak. Hospitals and clinics should stop using the device immediately and follow Baxter’s recall instructions. Contact Baxter or your healthcare provider for guidance.
Getinge Disinfection Ab recalled 788 units of the 88-Series Washer-Disinfector worldwide, including US states Colorado, Massachusetts, New Mexico and New Hampshire. The device can overheat if circulation pressure calibration is not performed or performed incorrectly and the low-pressure alarm fails to trigger. Manufacturers advise stopping use and following recall instructions.
Baxter Healthcare Corp. is recalling 18,720 CLEARLINK System Non-DEHP Conti-Flo Soln Sets sold nationwide in the United States. The IV sets may leak, potentially compromising therapy. Patients and healthcare providers should stop using the device immediately and contact Baxter Healthcare for instructions.
Baxter Healthcare Corporation is recalling 473,040 CLEARLINK SYSTEM CONTINU-FLO IV Solution Sets sold nationwide to healthcare providers. The IV sets may leak, increasing the risk of improper fluid administration. Stop using the product immediately and contact Baxter Healthcare Corporation or your healthcare provider for instructions.
Tas Tematic Foods recalled 5 cases of Frozen Raw Easy Peel Shrimp IQF 2-lb bags after the FDA flagged high nitrofuran levels. The product was distributed to two consignee locations in California. Consumers should not consume the shrimp and should seek refunds or replacements from Tas Tematic Foods.
Northeast Scientific recalled 165 units of the NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter sold nationwide in the United States. The recall cites the potential breach of sterile barrier packaging that could compromise sterility. The device is not cleared for marketing in the U.S. and has a high-risk hazard designation. Patients and healthcare providers should stop using the产品,
Herbal Creations recalls 19,425 kilograms of bulk colostrum powder distributed to 30 US customers after a milk allergen labeling error. The product label does not declare milk as an allergen. Consumers who purchased this product should not consume it and should contact Herbal Creations USA for refund or replacement.
Rolling Pin Baking Company LLC is recalling 127,680 Dubai Style Chocolate pouches sold through multiple retailers. The recall was announced on Aug. 29, 2025. The product does not declare wheat in the allergen statement. Consumers should not consume the product and contact the company by email for refund or replacement.
Northeast Scientific recalled 199 units of the NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. The device is not cleared for marketing in the United States. Distribution covered 17 states nationwide, including CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Healthcare providers were advised to stop use immediately.
Fresenius Medical Care recalls 172,494,732 Optiflux High Flux E-beam Dialyzers distributed nationwide in the United States. Caps on these dialyzers were changed from threaded to press-on versions, requiring users to press the caps firmly to secure them. Patients and healthcare providers should stop using these devices immediately and follow recall instructions issued by the manufacturer.
Baxter Healthcare Corporation recalled 958,351 CLEARLINK CONTINU-FLO IV sets due to a leak risk. The non-vented sets feature three Luer activated valves and a Backcheck Valve. Distribution covered nationwide in the United States. Healthcare providers and patients should stop using the device immediately and follow recall instructions on the recall notice.
Northeast Scientific Inc. has issued a recall for 616 units of the NES Reprocessed Turbo-Elite Laser Atherectomy Catheter, Model R-417-156. The FDA-listed recall cites breaches in sterile barrier packaging that could compromise sterility. The devices were distributed nationwide in the United States to CA, FL, IL, KS, LA, MD, MI, MO, NC, NJ, NM, NV, NY, PA, TN, TX, and VA. Patients should not be in
Baxter Healthcare Corp. recalled 12,720 CLEARLINK SYSTEM CONTINU-FLO IV sets distributed nationwide to healthcare facilities. The devices may leak during use. Hospitals and clinicians should stop using immediately and follow Baxter's recall instructions.
Baxter Healthcare recalls 49,200 CONTINU-FLO IV Solution Sets distributed nationwide in the United States. IV sets may leak. Healthcare facilities and patients should stop using the device immediately and follow Baxter's recall instructions.
Baxter Healthcare recalled 8,368 CLEARLINK SYSTEM CONTINU-FLO IV sets nationwide after reports the devices may leak. The non-vented sets include a 0.2-micron filter, three CLEARLINK luer activated valves and a backcheck valve, and measure 102 inches in length. Hospitals and clinicians should stop using these units immediately and follow Baxter's recall instructions.
ImaCor recalls 45 CLT-010 miniaturized TEE probes nationwide in five states after a production assembly error risks reversed articulation. The device is used with ImaCor model ZHH and Mobile Ultrasound. Stop using the device immediately and follow the manufacturer’s recall instructions.
Baxter Healthcare's CLEARLINK SYSTEM CONTIN-FLO IV infusion sets are recalled nationwide in the United States after 106,176 units were distributed to healthcare providers. The defect is that IV sets may leak. Healthcare facilities should stop using the device and follow Baxter's recall instructions.
Northeast Scientific recalled 173 units of the NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter distributed nationwide to U.S. healthcare facilities. The device is not cleared for marketing in the United States due to sterility concerns. A breach in the sterile barrier packaging could compromise sterility. Health care providers and patients should stop using the device immediately.