fda regulated Recalls

MicroPort Recalls HIPTURN Fem Head Trial Device Over FDA Violation

Due to products not having FDA Premarket authorization to be distributed within the United States.

Siemens Medical Recalls CT Software Over FDA Clearance Issues

Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.

Altruan GmbH Bisaf Strep A Self-Test Recalled for FDA Clearance Issue

Product not cleared by the FDA.

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

The supplier manufactured anatomical left plates with an incorrect thread orientation.

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Wondfo Streptococcal A At-Home Self-Test Recalled for FDA Clearance Issues (2026)

Product not cleared by the FDA.

Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Siemens Medical Recalls Software Due to Lack of FDA Clearance

Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.

Vascutek Gelsoft Plus and Gelweave Vascular Prostheses Recalled for Shelf-Life Label Error (37,430,

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles

Presence of particulate matter - Glass like particles.

Waterfront BISTRO Frozen Raw Shrimp Recalled for Cesium-137 Contamination

Waterfront BISTRO brand Frozen Raw Shrimp was recalled on December 18, 2025, due to possible contamination with Cesium-137. Approximately 1,800 cases of the product are affected. Consumers should not consume the shrimp and seek a refund or replacement.

ZIYAD Brothers Recalls Puff Pastry Over Hydrogenated Oils Hazard

ZIYAD Brothers Importing recalled 2,865 cases of French Style Puff Pastry on December 17, 2025. The product may contain partially hydrogenated oils, posing a health risk. Consumers should not consume the product and seek refunds immediately.

Broselow Pediatric Emergency Tape Recalled Over Dosing Errors

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Diagnostica Stago Recalls Asserachrom HPIA Kit Over False Negatives

Diagnostica Stago issued a recall for 438 Asserachrom HPIA kits on December 15, 2025. The kits, used to detect PF4 antibodies, may produce false negative results. The affected lot is 271288, distributed worldwide including multiple U.S. states.

Philips Recalls Allura Xper FD10F Systems Due to Electrical Hazard

So Delicious Dairy Free Frozen Dessert Recalled Due to Foreign Material

Prima Vera Nueva Tamales Recalled Due to Listeria Risk

Potential contamination with biological hazards (Listeria monocytogenes).

Prima Vera Nueva Tamales Recalled for Listeria Contamination

Potential contamination with biological hazards (Listeria monocytogenes).

Prima Vera Nueva Recalls Tamales Due to Listeria Risk

Potential contamination with biological hazards (Listeria monocytogenes).

Prima Vera Nueva Tamales Recalled for Listeria Risk

Potential contamination with biological hazards (Listeria monocytogenes).