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 22881–22900 of 38,428 recalls
Recalled Item: BlockAid Cut Resistant Surgical Glove Liners
The Issue: Cut resistant surgical glove liners lack sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed(TM) Pro-set(TM) (MMT-280
The Issue: Medtronic MiniMed(TM) Infusion Sets have the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed(TM) Mio(TM) (MMT-921
The Issue: Medtronic MiniMed(TM) Infusion Sets have the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed(TM) Sure-T(TM) (MMT-862
The Issue: Medtronic MiniMed(TM) Infusion Sets have the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed(TM) Silhouette(TM) (MMT-377
The Issue: Medtronic MiniMed(TM) Infusion Sets have the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed(TM) Quick-set(TM) (MMT-394
The Issue: Medtronic MiniMed(TM) Infusion Sets have the potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JS Series SterilContainer S2 System
The Issue: The JS Series SterilContainer S2 System was released
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to
The Issue: When the lever of the Insertion Handle is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISM MEDICAL A-625
The Issue: During internal cycle testing of A-Series lifts Handicare
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Delta Cup Beater Positioner - Aligner
The Issue: An internal analysis on complaints received indicated that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets
The Issue: There is potential that fluorescent platelet (PLT-F) and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The 2nd Assist Knee Positioner
The Issue: Zimmer Biomet is conducting a medical device recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoCheck5+
The Issue: Radiometer has recently become aware that a few
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT
The Issue: Biosense Webster, Inc. has recently received an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S
The Issue: Biosense Webster, Inc. has recently received an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
The Issue: Biosense Webster, Inc. has recently received an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S
The Issue: Biosense Webster, Inc. has recently received an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S
The Issue: Biosense Webster, Inc. has recently received an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.