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 17381–17400 of 38,428 recalls
Recalled Item: Erisma- LP posterior fixation system with the below specifically affected
The Issue: for the polyaxial screw to become disassembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MULTIGENT Lithium-intended for the quantitation of lithium in serum or
The Issue: Added an additional SmartWash parameter for the Lithium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity c Lithium Reagent Kit- intended for the quantitation of
The Issue: Added an additional SmartWash parameter for the Lithium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 19FR
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 19FR
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An...
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 15FR
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 19FR
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain 15FR
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An
The Issue: 15FR and 19FR round fluted drain channel drain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAC VU360
The Issue: Two issues: 1) The MAC VU360 system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Workstation
The Issue: Apple has determined that, in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed Insulin Pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic MiniMed Paradigm Veo Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed Paradigm 512 Insulin pump
The Issue: The action is being initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.