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 33761–33780 of 38,428 recalls
Recalled Item: Salmonella typhi/paratyphi Antigen Test
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rickettsia IgG/IgM Test Card LumiQuick
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Panel Test Card (Whole Blood)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDDP Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H. Pylori Antigen Test Card LumiQuick
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcohol Test
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCP Test (Strip)
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Methadone Test Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate II System Controller Product Usage: HeartMate II is a
The Issue: Discovery of serious injuries and deaths associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate II LVAD Pump and Pock Controller Kit
The Issue: Discovery of serious injuries and deaths associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heart Mate II Pocket Controllers removed from packaging Product Usage:
The Issue: Discovery of serious injuries and deaths associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate II Implant Kit with Pocket Controller
The Issue: Discovery of serious injuries and deaths associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm
The Issue: Medtronic is recalling a specific subset of lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm
The Issue: Medtronic is recalling a specific subset of lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Morph AccessPro Steerable Introducer
The Issue: Firm discovered the potential for particulates in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm
The Issue: Medtronic is recalling a specific subset of lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Morph AccessPro Steerable Introducer
The Issue: Firm discovered the potential for particulates in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.