689 recalls tagged with “fda regulated”.
Abiomed recalled 291 Impella RP with SmartAssist devices sold worldwide, including the US. A differential pressure sensor may malfunction and cause readings to drift. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Abiomed recalled 179 Impella RP devices worldwide after a differential pressure sensor may drift. The fault can cause sensor values to drift, potentially affecting patient care. Stop using the device immediately and follow the recall instructions, including contacting Abiomed or your healthcare provider.
Radnostix, Inc. is recalling 16 units of SODIUM IODIDE I-131 Solution distributed nationwide in the United States and Puerto Rico. The product contains particulate matter due to production issues. Healthcare providers and patients should stop using the product immediately and await a recall notification by letter.
Asteria Health recalled 670 testosterone pellets on January 26, 2026, due to potential metal particulate contamination. Consumers and healthcare providers must stop using the product immediately. The recall affects all units distributed nationwide in the United States.
Asteria Health recalled 22,478 Estradiol 12.5 mg pellets on January 26, 2026, due to potential metal particulate contamination. Consumers and healthcare providers must stop using the product immediately. The FDA classified this recall as Class II, indicating a high hazard level.
Asteria Health recalled 1,631 sterile pellets of Testosterone and Triamcinolone Acetonide on January 26, 2026, due to potential metal contamination. Consumers should stop using the product immediately. This recall affects products distributed nationwide in the USA.
Beacon Promotions recalled 5,788 units of repackaged M&Ms candies on January 26, 2026. The candies contain undeclared allergens, specifically milk, soy, and peanuts. Consumers should not consume these products and should seek refunds.
Asteria Health recalled 24,099 Estradiol, 10 mg pellets on January 26, 2026, due to potential metal particulate contamination. Consumers should stop using the product immediately. The recall affects pellets distributed nationwide in the USA.
Mangalm LLC recalled 40 cases of Tops GOLD Stuffed Red Chilli Pickle, 31.74 oz cans, distributed in California, Nevada, Oregon, Utah and Washington. The recall is due to potential adulteration with erucic acid from mustard oil. Consumers should not consume this product and should contact Mangalm LLC by email for a refund or replacement.
Mangalm LLC recalls 40 cases of Tops GOLD Lime Pickle, 31.74 oz jars, produced in India and distributed to California, Nevada, Oregon, Utah and Washington. The recall follows potential adulteration with erucic acid from mustard oil. Consumers who have purchased the product should not consume it and should contact Mangalm LLC for a refund or replacement via email.
Mangalm LLC recalled Tops GOLD Mixed Pickle sold in California, Nevada, Oregon, Utah and Washington after FDA enforcement. The product may be adulterated with erucic acid from mustard oil. Consumers who purchased it should not eat it and should contact Mangalm for refund or replacement via email.
Mangalm LLC recalls Tops GOLD Green Chilli Pickle, 31.74 oz cans sold in California, Nevada, Oregon, Utah and Washington. The recall cites potential adulteration with erucic acid from mustard oil ingredients. Consumers who purchased this product should not consume it and should contact Mangalm LLC for refund or replacement by email.
ITS GmbH recalls 101 Pilon Plate with Angular Stability implants distributed nationwide in the United States. Updated MRI safety testing shows higher RF-induced temperature increases under certain MRI conditions than described in the IFU. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
I.T.S. GmbH has recalled 5,568 units of the I.T.S. Screw System sold nationwide in the United States after MRI safety tests showed higher RF-induced temperature increases under some MRI conditions than the IFU outlined. The defect involves MRI RF heating that could burn patients. Patients and healthcare providers should stop using the device immediately and follow the recall instructions.
ITS GmbH recalled 11 Pelvic Reconstruction System PRS components after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions than described in the IFU. The recall covers Fixation Screw 70312 and Spike short 70314. Healthcare providers and patients should stop using the devices and follow the manufacturer’s recall instructions provided by email.
I.T.S. GmbH recalled 220 Volar Radius Plate PROlock II devices after updated MRI safety testing showed higher RF-induced temperatures under certain MRI conditions. The devices were distributed nationwide in the United States. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.
ITS GmbH recalled 176 units nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases under certain MRI conditions. The issue could cause burns during MRI exposure. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
I.T.S. GmbH recalled 120 units of its DUL and UOL ulna locking plate systems distributed nationwide to U.S. healthcare providers after MRI safety testing showed higher RF-induced heating. The updated testing found temperature increases under certain MRI conditions not reflected in the Instructions for Use. Healthcare facilities and patients should stop using the devices immediately and follow the厂
Datascope recalled 10,897 CS100 IABP devices worldwide on Jan. 23, 2026. The issue concerns battery runtime and cycle specifications in the device Instructions for Use. Healthcare providers and patients must stop using the device and follow recall instructions.
ITS GmbH recalled 1,307 units of the HLS Hand Locking Plates System distributed nationwide in the United States after MRI safety testing showed higher RF-induced temperature increases. The issue exceeds what is described in the IFU under certain MRI conditions. Patients and healthcare providers should stop using the device immediately and follow ITS GmbH's recall instructions.