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 2001–2020 of 38,428 recalls
Recalled Item: Zvu Anorectal Manometry Procedure Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4 Total ELISA Product Name: T4 Total ELISA
The Issue: An incoming complaint reported that the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20. Fluoroscopic X-Ray System.
The Issue: for bolts connecting the gearbox to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
The Issue: Products have the incorrect platelet (PLT) value assignments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
The Issue: Products have the incorrect platelet (PLT) value assignments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
The Issue: Products have the incorrect platelet (PLT) value assignments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA¿ 120/2120/2120i SETpoint Calibrator
The Issue: Products have the incorrect platelet (PLT) value assignments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UROSKOP Omnia. Model Number: 10094910
The Issue: A resistor in the frequency inverter may strongly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UROSKOP Omnia Max. Model Number: 10762473
The Issue: A resistor in the frequency inverter may strongly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton C6 (ESM Board PN 10144626 UDI-DI code:
The Issue: A mechanical defect on a printed circuit board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve
The Issue: Due to a manufacturing issue, disinfecting cap for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bravo CF capsule delivery device
The Issue: It has been determined that misapplied adhesive on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, errors in spectral overlap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Cather packaging may contain the incorrect French size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Heyman Follower Straight Tip for following sizes: 10Fr -
The Issue: Cather packaging may contain the incorrect French size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, errors in spectral overlap
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Heyman Follower Coude Tip for following sizes: 12Fr -
The Issue: Cather packaging may contain the incorrect French size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medshape Universal Joints
The Issue: Bone external fixation system may have the pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product
The Issue: Due to packaging discrepancy with the incorrect tibial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product
The Issue: Due to packaging discrepancy with the incorrect tibial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.