Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 32481–32500 of 38,428 recalls
Recalled Item: Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
The Issue: Philips had discovered through a field service testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rejuvenator Chamber manufactured by Baro-Therapies
The Issue: The firm is distributing the Rejuvenator device without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is
The Issue: CareFusion has identified a potential for damage to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Respiratory Modules E-sCO
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA The Personalized Knee System Constrained Tibial Articular Surface...
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial...
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left
The Issue: Reports of breakage of the Persona Knee Trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliSpace ECG Management System
The Issue: Philips IntelliSpace ECG (IECG) Management Systems that are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MobileDiagnost wDR motorized portable diagnostic X-ray systems.
The Issue: Reports of unexpected movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parker Eclipse Probe Cover
The Issue: Parker Laboratories, Inc. received a report of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)
The Issue: The component supplier recalled their 0.9% Sodium Chloride
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative
The Issue: VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems
The Issue: The ADVIA Chemistry Systems A1c_3 method may exhibit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are
The Issue: The primary packaging label (inner pouch label) indicates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTRACK250A Canaloplasty Microcatheter Kit
The Issue: One lot may not have been properly sealed,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE
The Issue: AngioDynamics became aware that Uni*Fuse Infusion Systems with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE
The Issue: AngioDynamics became aware that Uni*Fuse Infusion Systems with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.