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 29081–29100 of 38,428 recalls
Recalled Item: LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 6F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Single Lumen Embolectomy Catheter 5F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 7F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre Over-the-Wire Embolectomy Catheter 3F
The Issue: Manufacturing issue that could cause a pinhole in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tool Legend 16cm 2.4 mm wire pass for Midas Rex
The Issue: The wire pass hole is not present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Tracking Bracket Starter Kit
The Issue: Sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Sales Demo Kit. Large Gauge Infiniti Plus
The Issue: Sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Needle Guide Starter Kit
The Issue: Sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO Infiniti Plus Needle Guide
The Issue: Sterility of the product cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR
The Issue: Cook Medical has received six product complaints associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT
The Issue: The devices were packaged and laser marked anatomically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10-Panel Pipette Drug Screen
The Issue: Ameditech is recalling drug abuse tests because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT
The Issue: The devices were packaged and laser marked anatomically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion
The Issue: SCFE Driver's threaded shaft broke close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration)
The Issue: Ameditech is recalling drug abuse tests because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DrugSmart 11 Test Cup
The Issue: Ameditech is recalling drug abuse tests because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMO FISHER 6 DRUG CASSETTE
The Issue: Ameditech is recalling drug abuse tests because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.