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 6621–6640 of 38,428 recalls
Recalled Item: Exactech Vantage Mobile Bearing Tibial Inserts
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Equinoxe Reverse Shoulder System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Optetrak Knee System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Optetrak Logic PS Knee System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Novation Hip System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Alteon Hip XLE Liner
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Truliant Knee System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Truliant
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Optetrak Logic Knee System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Vantage Ankle System
The Issue: Exactech has received 3 complaints for 4 devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica HistoCore PEGASUS (PROCESSOR
The Issue: There is an issue regarding poorly processed and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovoTHOR Whole Body Light Pod
The Issue: One of the ball studs attaching a gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibration Serum Level 3 - IVD For use as a
The Issue: Target for Alkaline Phosphatase (ALP) for the AMP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibration Serum Level 3 CAL2351
The Issue: CK Total in Calibration Serum Level 3, CAL2351,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5
The Issue: Instructions for Use-User Deviations related to the reprocessing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protege GPS Self-Expanding Peripheral Stent System
The Issue: Seal defects could compromise the ability of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10
The Issue: Instructions for Use-User Deviations related to the reprocessing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Dressing change kit
The Issue: ROi CPS manufactured and distributed medical convenience kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KeySplint Hard Clear - Indicated for the fabrication of orthodontic
The Issue: Keyprint Keysplint Hard Clear 1 kg resin bottles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirTouch F20 Full Face Mask and User Guide
The Issue: Masks non-invasive interface for channeling airflow to patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.