All Product Recalls

Boston Scientific Recalls AXIOS Stent Over Deployment Issues

Boston Scientific Issues Recall for Stent Due to Deployment Issues

Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.

Tyber Medical Recalls VOLT Wrist Treatment System Due to Hazard

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

Altruan GmbH Clearest Strep-A Cassette Test Recall 188 Units (2025)

Product not cleared by the FDA.

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

Product not cleared by the FDA.

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Failed Disintegration Specifications: above the time expected.

Canon Medical Recalls Interventional X-Ray System Over Safety Risk

Siemens Medical Solutions Recalling CT Software Over Clearance Issues

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.

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

Product not cleared by the FDA.

ICU Medical Recalls Pulsator Arterial Blood Sampling Kit for Hazard

ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.

Novo Nordisk Issues Recall of Wegovy Injection Due to Contamination

Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

Presence of Particulate Matter: Hair was found in a prefilled syringe

Zydus Pharmaceuticals Recalls TraZODONE Tablets Over Defects

Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.

Gregory's Foods Cookie Dough Recalled for Undeclared Peanuts

Gregory's Foods recalled 308 cases of White Chocolate Macadamia Nut frozen cookie dough on December 19, 2025. The product contains undeclared peanuts, posing a serious allergy risk. Consumers should not consume the product and seek refunds.

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Canon Medical MRI Systems Recalled Over High-Pressure Risk

Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.