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 5861–5880 of 38,428 recalls
Recalled Item: Centurion OB INSTRUMENT TRAY
The Issue: Trumpet Needle Guide ring can detach when excessive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Cholestech LDX Battery Kit
The Issue: There is a potential that the Cholestech LDX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate 3
The Issue: for a leak path at the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate 3
The Issue: for a leak path at the seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peel-Away Introducer - Intended for the percutaneous introduction of balloon
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dilator - Intended to be used for dilating puncture sites
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yueh Centesis Disposable Catheter Needle - Intended for use in
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trocar Needle - Used for dilating puncture sites or catheter
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dilator - Coons Taper - Used for dilating puncture sites
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dilator With AQ Hydrophilic Coating - Intended to be used
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chiba Biopsy Needle - Used for aspiration biopsy. PART
The Issue: Packaging may have low seal strength and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mojo 2 Full Face AAV Non Vented Mask
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iQ 2 Nasal Vented Mask
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mojo 2 Full Face Non Vented Mask
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mojo Non Vented Full Face Mask with Headgear
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mojo 2 Full Face Vented Mask
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phantom 2 Nasal Vented Mask
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mojo Full Face with Headgear
The Issue: Update to contraindications and warning language due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used
The Issue: The firm has realigned C3 and Haptoglobin in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.