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 27681–27700 of 38,428 recalls
Recalled Item: Pneumatic Impactor
The Issue: MicroAire discovered that 20 suspect Impactor instruments (
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra 3
The Issue: The units have been fitted with a potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TC-PLUS(TM)
The Issue: The Affected Devices may contain a dimensional deviation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis One
The Issue: After importing segmentation results of the left atrium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freedom60 Precision Flow Rate Tubing Sets
The Issue: On 2/24/2016 during post sterilization inspection of part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIgH-Flo Subcutaneous Safety Needle Sets
The Issue: On 2/24/2016 during post sterilization inspection of part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Schiller PB 1000
The Issue: If the PDM is utilized to output a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.