cpsc regulated Recalls

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

Tornier Recalls Surgical Screws Over Labeling Error

Canon Medical Recalls MRI Systems Over High-Pressure Hazard

Canon Medical Recalls Interventional X-ray System Over Safety Hazard

Boston Scientific Recalls Stent System Due to Deployment Issues

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.

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.

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

Product not cleared by the FDA.

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

Product not cleared by the FDA.

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

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.

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.

Canon Medical Recalls Alphenix INFX-8000C X-Ray System Over Safety Risk

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.

Rifton Equipment Recalls TRAM Lift Device Over Strap Hazards

Potential for fraying on the body support strap.

CATAO MARKET Recalls Cuban Loaf Cake Over Undeclared Color Additive

CATAO MARKET recalled 3,120 Cuban loaf cakes on December 18, 2025. The recall follows the discovery of undeclared FD&C Yellow #5 in the product. This hazard poses a significant risk for consumers with allergies to this color additive.

KKL Fabric Dressers Recalled Over Tip-Over Hazard

Rifton Equipment Recalls Low Base TRAM Due to Fraying Hazard

Potential for fraying on the body support strap.

CATAO MARKET Recalls Cuban Loaf Cake Due to Undeclared Color Additive

Undeclared colors FD&C Yellow #5