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 5901–5920 of 38,428 recalls
Recalled Item: TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision
The Issue: The acetabular shell may have excessive deburring, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz SE & CO. KG
The Issue: Inadequate reprocessing validation evidence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec CarboFlex
The Issue: The product does not meet sterility assurance level
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz SE & CO. KG
The Issue: Inadequate reprocessing validation evidence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Karl Storz SE & CO. KG
The Issue: Inadequate reprocessing validation evidence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Performance Verifier I
The Issue: The issue was mismatched diluent lots assembled into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
The Issue: Failure of adhesive to secure the pole insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Performance Verifier II
The Issue: The issue was mismatched diluent lots assembled into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1)
The Issue: Complaints have been received that the device inflation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.