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 18381–18400 of 38,428 recalls
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: The MX40 may experience increased power consumption and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: The MX40 may experience increased power consumption and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: The MX40 may experience increased power consumption and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: The MX40 may experience increased power consumption and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The
The Issue: There is a potential of fracture, bending or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T7 Driver Solid AO (Part Number 110018541) Product Usage: The
The Issue: There is a potential of fracture, bending or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences
The Issue: Difficulty with atrioseptostomy catheter balloon deflation after deployment,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences
The Issue: Difficulty with atrioseptostomy catheter balloon deflation after deployment,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
The Issue: ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ Derm Porcine Xenograft
The Issue: Intermittent heat seal failures on the outer pouch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion One
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Prime SP
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Prime
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Lightning
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Precision
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion One Vision
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion Premium
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canon Aquilion One
The Issue: Scanning may be interrupted due to an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-G5
The Issue: New software version for affected ventilators reduces the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology Hemo
The Issue: users are not notified of procedure medication discrepancies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.