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 14481–14500 of 38,428 recalls
Recalled Item: Flexible DCI Intubation Fiberscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Intubation Video Endoscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE SPECIALIZED ORTHOPEDICS
The Issue: During explantation, standard removal tools can generate sufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DABRA RA-308 Excimer Laser
The Issue: Due to the taller wheel mounting on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In
The Issue: Dimension Vista High Sensitivity Troponin I (TNIH) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Sensis Vibe Hemo system in combination with the MicroPodTM
The Issue: The connector linking the EtCO2 module to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The
The Issue: The catalog ( REF ) number on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific Remel Bordetella pertussis Agglutinating Serum Product...
The Issue: Thermo Scientific" Remel" Bordetella pertussis Agglutinating Serum (R30165501/ZM
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 Software Version R1.0 and R1.1
The Issue: Philips has become aware of a software issue,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTERA Spacer ALTERA Spacer
The Issue: Specific lots of ALTERA¿ implants have internal components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.