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 1201–1220 of 38,428 recalls
Recalled Item: ECHELON LINEAR Cutters Reload 80 mm Blue
The Issue: The devices were shipped unsterilized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TENACIO Pump with InhibiZone
The Issue: The potential for devices to experience inflation and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LGX Preconnect with TENACIO Pump without InhibiZone
The Issue: The potential for devices to experience inflation and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The failure occurs if a user on the Omnipod 5
The Issue: The failure occurs if a user on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CXR Preconnect with TENACIO Pump with InhibiZone
The Issue: The potential for devices to experience inflation and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CX Preconnect with TENACIO Pump without InhibiZone
The Issue: The potential for devices to experience inflation and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.