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 36961–36980 of 38,428 recalls
Recalled Item: VENTANA (a member of the Roche Group) DISCOVERY ULTRA
The Issue: for a waste fluid overflow condition to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENTANA (a member of the Roche Group) BenchMark ULTRA
The Issue: Potiential for a waste fluid overflow condition to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical System Extended Brilliance Workspace (EBW)
The Issue: Incorrect values may be displayed. Philips is issuing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pro Time Microcoagulation System/ Pro Time 3 Cuvette
The Issue: Some Pro Time3 Test Cuvettes within a specified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System
The Issue: Philips is issued a Field Change Order to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Segmented Cervix Applicator Set
The Issue: The guide tube which is part of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is Full OSSEOTITE Parallel Walled Certain Implant
The Issue: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is Full OSSEOTITE 2 Tapered Certain Implant
The Issue: Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes External Fixation System Tube to Tube Clamp
The Issue: The insert provided with the product for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3 PORT "OFF" MANIFOLD w/WASTE BAG
The Issue: ICU Medical, Inc. has identified a potential comingling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5mm Cancellous Bone Screw Intended to be used for the
The Issue: A product complaint was received where a size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x
The Issue: Cellestis is recalling QuantiFERON¿¿ - TB Gold TB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN
The Issue: Cellestis is recalling QuantiFERON¿¿ - TB Gold TB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeGotzen XRay unit XGenus Dental X-ray unit.
The Issue: It was discovered at the WEAC Labs method
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Definium 5000 / 5220493 X-Ray System
The Issue: When quickly switching the protocols from AEC to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Definium 5000/5220493-2 X-Ray System
The Issue: When quickly switching the protocols from AEC to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ***This recall is being conducted due to an incomplete recall
The Issue: This recall is the same issue for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (l) Visum Halogen Surgical Light
The Issue: Stryker has become aware that there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perfusion System 8000
The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received multiple
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perfusion System 8000
The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received multiple
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.