immediate action Recalls

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

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

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

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

Boston Scientific Recalls Stent System Due to Deployment Issues

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

Product not cleared by the FDA.

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.

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Failed Disintegration Specifications: above the time expected.

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 Alphenix INFX-8000C X-Ray System Over Safety Risk

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.

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.

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.

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

Canon Medical Recalls Interventional X-Ray System Over Safety Risk

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.

Tornier Recalls Surgical Screws Over Labeling Error

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.

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.

Boston Scientific Recalls HOT AXIOS Stent Over Deployment Issues

Canon Medical System Recalls Interventional X-Ray Systems Over Safety Risk