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 37001–37020 of 38,428 recalls
Recalled Item: ARIA Radiation Oncology
The Issue: An anomaly has been identified with the ARIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no.
The Issue: We are notifying you of a potential interaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal
The Issue: Terumo Cardiovascular Systems (Terumo CVS) received one report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Centrifugal System Control module
The Issue: Terumo Cardiovascular Systems (Terumo CVS) received one report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Centrifugal System Control module
The Issue: Terumo Cardiovascular Systems (Terumo CVS) received one report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamigo i-Phone App The Diamigo app was intended for use
The Issue: Diamigo, a software application, was released through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The...
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asahi KASEI
The Issue: Asahi became aware of a negative trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware that patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The TM Ardis Interbody System Inserter Stainless Steel
The Issue: Zimmer Spine is has received complaints of difficulty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA ML
The Issue: Horiba Medical is recalling ABX PENTRA ML because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD NX Cassettes
The Issue: Advanced Sterilization Products is recalling three lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Total Knee CDS
The Issue: The Back Table Cover component in the custom
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging
The Issue: It was discovered GE Healthcare has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.