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 33921–33940 of 38,428 recalls
Recalled Item: Citation TMZF HA 132 degrees Neck Angle
The Issue: Stryker received a report from the field indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000
The Issue: There is a potential for incorrect results to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Treatment packs used on the VisuMax Laser Keratome. Size M
The Issue: Carl Zeiss Treatment pack, lot number M 130010,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemStar infusion pump
The Issue: The connection between the beeper subassembly and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers:
The Issue: Otto Bock is recalling all Aerial and Aerial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat...
The Issue: The MAQUET post-marketing vigilance program has identified a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Greatbatch Medical
The Issue: Greatbatch Medical has initiated a global Field Corrective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes CMF Battery Powered Driver
The Issue: The CMF Battery Powered Driver graphic case contains
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage:
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena...
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE1055: Prevena Dressing
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The...
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE2001: Prevena Incision Management Customizable System Box Product Usage: The
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE1001: Prevena Peel and Place System Kit Product Usage: The
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY)...
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRE1055US: Prevena Dressing
The Issue: Prevena Incisional Management System Kit/Dressing Connector - the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Select CAP Arterial Cannulae. Non-Vented
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Select 3D Arterial Cannulae. Vented
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Select 3D Arterial Cannulae. Vented
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Intersept Custom Tubing Pack which contain Select 3D or
The Issue: Medtronic is recalling all models of its Select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.