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 4941–4960 of 38,428 recalls
Recalled Item: TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.