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 19821–19840 of 38,428 recalls
Recalled Item: BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter)
The Issue: One lot of the specified needles is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters
The Issue: Several lots of Jelco¿ ViaValve" safety intravenous (I.V.)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER
The Issue: The sterilization process used was unqualified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp :
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System 12mm SpinDown Clamp
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING
The Issue: The sterilization process used was unqualified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp :
The Issue: Spin Down RapidFlap nut that interfaces with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-005-152
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-005-152
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-105-251
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-005-153
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-105-151
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-005-151
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-005-051
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-005-251
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon Natura Model 210-005-151
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon GENILook Model 200-005-251
The Issue: There is potential for the plastic optical tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.