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 17661–17680 of 38,428 recalls
Recalled Item: Tibial Tray Nonporous A Size 2
The Issue: The locking mechanism of the tibial tray exhibited
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Tray Nonporous A Size 4
The Issue: The locking mechanism of the tibial tray exhibited
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Thermocouple Electrode
The Issue: The firm initiated a voluntary correction of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Thermocouple Electrode
The Issue: The firm initiated a voluntary correction of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Thermocouple Electrode
The Issue: The firm initiated a voluntary correction of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Thermocouple Electrode
The Issue: The firm initiated a voluntary correction of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Thermocouple Electrode
The Issue: The firm initiated a voluntary correction of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babi.Plus 12.5 cm H2O Pressure Relief Manifold
The Issue: Reports of pressure relief manifold venting gas below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold
The Issue: Reports of pressure relief manifold venting gas below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply
The Issue: Reports of pressure relief manifold venting gas below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
The Issue: Surface micro/nano topography on some of the implants
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number:
The Issue: Lot has been confirmed to have no additive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anti-fog solution packaged in a Tyvek peel pouch and it
The Issue: The Anti-Fog Solution may not defog properly due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Pump Console
The Issue: for Quantum Pump Console, part of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SLIM Handle - catalogue #: SLM-HND100 a component of Simple
The Issue: Handle could jam with the Driver due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liberty Cycler Cassettes (a disposable cassette that is intended to
The Issue: Additional Instructions: step-by step handling and inserting the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratus CS Acute Care cTNI TestPak
The Issue: for increased rate of false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set -105"ADMIN SET 20DP W/FILTER 2YSITES CLMP-
The Issue: Administration sets assembled with inverted pinch clamp cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Administration Set -105"ADMIN SET 20DP
The Issue: Administration sets assembled with inverted pinch clamp cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPi-Sense Guided Coagulation System with Visitrax
The Issue: The sterile package seal for the Epi-Sense Guided
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.