1,320 recalls tagged with “fda regulated”.
Amy's Kitchen recalled 38,856 frozen Gluten Free Bean & Rice Burritos across 3,238 cases distributed to 21 states on Oct. 2, 2025. The recall cites potential contamination with foreign objects. Consumers should not eat the product and should contact Amy's Kitchen for refund or replacement information.
ICU Medical recalls 23,203 IV gravity burette sets worldwide. The burette component is missing an internal shutoff valve, which can delay therapy, cause overdelivery, or allow air to be infused. Stop using the device and contact ICU Medical for instructions.
Leprino Foods recalled 5,453,442 pounds of LMPS bulk mozzarella distributed to Ohio, Tennessee, Texas, Utah and Wisconsin after the FDA enforcement notice. The recall cites the possible presence of stainless steel pieces in the product. Consumers should not consume the mozzarella and should contact Leprino Foods for refund or replacement information.
DEMERS FOOD GROUP LLC is recalling Scott & Jon's Shrimp Scampi with Linguine, 9.6 oz, sold nationwide. The linguine component, manufactured by Nate's Fine Foods LLC, was recalled for Listeria monocytogenes and linked to an ongoing outbreak. Consumers should not consume the product and should contact DEMERS FOOD GROUP LLC for refund or replacement using email, fax, letter, press release, telephone,
Abiomed recalled 10,153 Automated Impella Controllers and related components due to potential cybersecurity vulnerabilities in the operating system. The recall spans multiple international product codes and was first issued for devices distributed nationwide and internationally. Providers should stop using the affected controllers and follow manufacturer instructions immediately.
Camber Pharmaceuticals recalled Ketorolac Tromethamine Injection, USP, 60 mg/2 mL, 2 mL single-dose vials distributed nationwide in the United States. The recall is due to the presence of glass particulates. Healthcare providers and patients should stop using the product immediately and contact Aspiro Pharma Limited at 1-866-495-1995 for guidance.
Church & Dwight recalled 21,912 bottles of ZICAM Cold Remedy Medicated Fruit Drops Elderberry from nationwide distribution in the United States. The label did not indicate elderberry as an ingredient though the product contains elderberry. Consumers should stop using the product and contact Church & Dwight for guidance.
B BRAUN MEDICAL recalled 1,298,454 STREAMLINE BLOODLINE SET FOR DIALOG devices nationwide in the United States after observations of micro-air bubbles and air-in-line alarms linked to damaged arterial and venous connectors. The defect increases the risk of air entering the bloodstream during dialysis. Patients and healthcare providers should stop using this device immediately and follow the recall
Ocean's Kitchen recalled 496 cases of imitation crab meat shredded, distributed in Washington state. The product is refrigerated and vacuum-packaged. The recall cites potential contamination with Clostridium botulinum due to temperature abuse during chilled storage. Consumers should not consume the product and should contact Oceans Kitchen for refunds or replacements.
Acella Pharmaceuticals recalls doxycycline hyclate tablets, 100 mg, 500-count bottles distributed nationwide in the USA. Stability testing found the lot did not meet dissolution specifications. Consumers and healthcare providers should stop using the product immediately and contact Acella for guidance.
Philips Medical Systems Nederland B.V. recalled 29 Zenition 50 interventional fluoroscopic x-ray systems distributed in 14 countries. The defect is corrosion of the IITV control board that may cause loss of imaging functionality or poor image quality. Healthcare providers and patients should stop using the device and follow manufacturer instructions for recall remediation.
Medline Industries recalled 222,800 alcohol prep pads nationwide on Sept. 29, 2025 due to subpotent potency. The pads are 2-ply, 70% isopropyl alcohol. Stop using immediately and contact Medline or your healthcare provider for guidance.
Vicky IT recalled 10 pounds of Bona Fish distributed in New York after FDA enforcement flagged the product for serious safety hazards. The recall cites un-eviscerated fish that may be contaminated with Clostridia botulinum, along with mold and insect larvae. Consumers who bought Bona Fish should not consume it and should contact Vicky IT for a refund or replacement.
Albertsons Companies recalled Basil Pesto Bowtie Pasta Salad sold at banners including Andronico's Community, Markets, Pak'N Save, Safeway and Vons due to Listeria monocytogenes contamination. The recall involves a store-made deli item with a bowtie pasta ingredient. Consumers should not consume the product and should contact Albertsons Companies LLC for refunds or replacements.
Wegmans Food Markets recalls 521 units of Wegmans 58 oz Ultimate Blueberry Cheesecake sold in Virginia, Maryland, North Carolina and Washington, D.C. The product contains undeclared pecans, creating an allergy risk. Consumers who purchased the cheesecake should not eat it and should contact Wegmans for a refund or replacement.
Synthes (USA) Products LLC recalled 120 low-profile locking screws for intramedullary nails used in the RFN-Advanced Retrograde Femoral Nailing System and the Tibial Nail Advanced System. The recall covers devices distributed worldwide through healthcare providers. The external packaging mislabels screw lengths: 42 mm screws are labeled 46 mm and 46 mm screws are labeled 42 mm. Hospitals and spine
Dr. Reddy's Laboratories Inc. recalled 571 vials of Succinylcholine Chloride Injection, USP nationwide in the United States. The recall cites an out-of-specification result during six-month stability testing due to decreased preservative concentration. Healthcare providers and patients should stop using the product immediately and await guidance from the recall letter.
The recall was issued on September 26, 2025. It covers Ready Meals Smoked Mozzarella With Hot Links Extra Large sold under Carrs-Safeway, Eagle, and Safeway banners in Alaska and multiple other states. The cause is Listeria monocytogenes linked to a recalled Penne pasta ingredient used in store-made deli items. Consumers should not eat the product and should contact Albertsons Companies LLC for a
Reser’s Fine Foods recalled 3,252 cases of Basil Pesto Bowtie Pasta Kit Item V, UPC 13454 38053, distributed in AZ, CA, CO and TX. The recall concerns potential contamination with Listeria monocytogenes. Consumers should not eat the product and should seek refund or replacement.
A high-risk recall affects 795 cases of Reser’s Fine Foods Basil Pesto Bowtie Pasta Kit distributed in Arizona, California, Colorado, Utah and Washington. The recall covers item #404736 with use-by dates in October 2025. Consumers should not consume these salad kits and should contact Reser’s for refunds or replacements.