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 15881–15900 of 38,428 recalls
Recalled Item: FlexTip Plus Combined Spinal Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexTip Plus Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIDURAL CATHETERIZATION KIT
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexTip Plus Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexTip Plus Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIDURAL CATHETERIZATION KIT
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexTip Plus Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexTip Plus Epidural Catheterization Kit
The Issue: There is the potential for various failures with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ormco Damon Q2 Orthodontic Metal Bracket
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard Microset For Use with the BodyGuard Infusion Pump ***
The Issue: The filter installed onto the tube set may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to
The Issue: Demonstration Simulus Reusable Sizer Accessory Kits were being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage:
The Issue: Demonstration Simulus Reusable Sizer Accessory Kits were being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambulance Parameter Extension (APE) kit M4758A
The Issue: M4758A Ambulance Parameter Extension (APE) kit may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT G3+ cartridge (blue)
The Issue: Marketed without a 510(k). Abbott Point of Care
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigiTrak XT Holter Recorder Software version number B.1 and
The Issue: if an AAA battery is inserted in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pilling Aortic Punch
The Issue: There is a potential for the device packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Medical Disposable Aortic Punch
The Issue: There is a potential for the device packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DP-30 Digital Ultrasonic Diagnostic Imaging System
The Issue: The DP-30 displays an incorrect needle-guide bracket when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90
The Issue: Incorrect power of lenses than the expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Bard Intra-abdominal Pressure Monitoring Device is composed of a
The Issue: Leaks or disconnect near the sampling port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.