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 22041–22060 of 38,428 recalls
Recalled Item: Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
The Issue: The concentrations for biotin listed in the non-interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125)
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE ¿ 1000 TG
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ Folate (FOL)
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas...
The Issue: The previous version of method sheets for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable
The Issue: An EEPROM chip error code may occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable
The Issue: An EEPROM chip error code may occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000C Fluoroscopic X-Ray Systems
The Issue: During an examination a device error occurred and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000F Fluoroscopic X-Ray Systems
The Issue: During an examination a device error occurred and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000H Fluoroscopic X-Ray Systems
The Issue: During an examination a device error occurred and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000V Fluoroscopic X-Ray Systems
The Issue: During an examination a device error occurred and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO-KATH Epidural Catheter Set
The Issue: for stylet to protrude from the distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO-KATH(TM) Caudal Set
The Issue: for stylet to protrude from the distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2M insert 15degree for MUTARS RS cup and LUMiC TiN
The Issue: Possibility that the retaining ring in the 2M
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYPOTHERMIA CAP Supportive in Cancer
The Issue: Hypothermia mitts, hypothermia slippers, and hypothermia caps on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYPOTHERMIA SLIPPERS Supportive in Cancer
The Issue: Hypothermia mitts, hypothermia slippers, and hypothermia caps on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYPOTHERMIA MITTS Supportive in Cancer
The Issue: Hypothermia mitts, hypothermia slippers, and hypothermia caps on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPICC Provena Catheters
The Issue: leaks on the 3 Fr. Single lumen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.