Health & Personal Care Recalls

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

Product not cleared by the FDA.

Boston Scientific Recalls AXIOS Stent Due to Deployment Risks

ICU Medical Recalls Needles Free Access Devices Due to High Risk of Leakage

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Tornier Recalls Surgical Screws Over Labeling Error

Tyber Medical Recalls VOLT Wrist Treatment System Over Thread Issue

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

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.

Sato Pharmaceutical Recalls INON ACE Antacid Tablets for Disintegration Issues

Failed Disintegration Specifications: above the time expected.

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

Product not cleared by the FDA.

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 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.

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.

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

Product not cleared by the FDA.

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.

Novo Nordisk Recalls Wegovy Injection Due to Contamination Risk

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

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles

Presence of particulate matter - Glass like particles.

Imprimis NJOF Recalls Intraocular Injection Over Glass Particles Hazard

Imprimis NJOF, LLC recalled 596 boxes of intraocular injections on December 18, 2025. The recall affects products due to the presence of glass-like particles. Consumers should stop using the product immediately and contact their healthcare provider.

Rifton Recalls E-Pacer Gait Training Device Over Fraying Risk

Rifton Equipment recalled 470 E-Pacer gait training devices on December 18, 2025. The body support strap may fray, posing a risk to users. Health care providers and patients must stop using the device immediately.

Imprimis NJOF Recalls Intraocular Injection Due to Glass Particles

Presence of particulate matter - Glass like particles.

TopHomer Pool Drain Covers Recalled Over Drowning Hazards

TopHomer recalled pool drain covers on December 18, 2025, due to serious entrapment and drowning hazards. The recall affects 8-inch drain covers sold on Amazon. Consumers should immediately stop using the products and seek refunds.