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 15521–15540 of 38,428 recalls
Recalled Item: Probe
The Issue: As part of an investigation into a biocompatibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOLITH URO-TCH 9FR PROBE 54CM
The Issue: Investigation into a biocompatibility test discrepancy where a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products TT4 Reagent Pack
The Issue: The specified reagent packs exhibit an increase in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL800 FLEX
The Issue: Analyzer's barcode reader misinterprets the contents of barcode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom convenience kits containing Medline brand Sterile Pre-Saturated...
The Issue: Medline identified that there may be a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN:
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
The Issue: An erroneous concentration value for hepatitis A virus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN:
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN:
The Issue: An increase in the rate of complaints for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The CF-70 instrument (product code: LXG
The Issue: Software mismatch-When the software versions between the SP-50
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVE 2 Birthing Bed - Product Usage: is designated to
The Issue: The UDI on the device label indicates incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.