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 31961–31980 of 38,428 recalls
Recalled Item: The 5085 is a general surgical table with high patient weight capacity
The Issue: The 5085 and 5085SRT stainless steel column shrouds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur (including ) Professional use in a laboratory for
The Issue: A slight crack of the tubing at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur XP Immunoassay System (including ) Professional use in
The Issue: A slight crack of the tubing at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard Catheter An active safety engineered peripheral IV
The Issue: BD Insyte Autoguard may have potential damage along
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MX 16-slice CT Scanner System and MX 16-slice CT Scanner
The Issue: "The orientation of images is displayed incorrectly. When
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device
The Issue: Cleaning process validation failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
The Issue: If the laser system is turned on and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TITAN Operating Room Table Patient positioning during surgery
The Issue: Unintended movement of the operating table during surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack III (4)
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cesarean Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OB Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OB Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O.R. Towels
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endovenous Custom Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minor Laparotomy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extremity Arm Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cysto Tur Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urology Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minor Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.