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 25541–25560 of 38,428 recalls
Recalled Item: PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE...
The Issue: Recalling dilators included with the 6F PreludeEASE Hydrophilic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRU-Balance 3 Power Positioning Systems
The Issue: The interface between the TB3 back and tilt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia MR-OR
The Issue: Possibility that a patient or user may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A
The Issue: A complaint of the PRO2 jaw breaking prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿
The Issue: ICU Medical Inc. has identified an isolated event
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8450-107-525 2.5MM Precision Match Head
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8450-009-040 4.0MM Precision Round
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is conducting a recall on Boston
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8470-009-040 4.0MM Precision Round
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8450-107-530 3.0MM Precision Match Head
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8470-009-030 3.0MM Precision Round
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8450-010-040 4.0MM Round
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8450-009-030 3.0MM Precision Round
The Issue: Stryker Instruments is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ecolab
The Issue: The reason for the recall is that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CentraLink¿ Data Management System Software Versions: v13x
The Issue: There is a remote possibility CentraLink may download
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical 400 Series Express Drains as follows: 4000-100N Express
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single
The Issue: Outer Packaging is not sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.