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 4921–4940 of 38,428 recalls
Recalled Item: Philips Allura Xper FD20 Biplane system with an ADN7NT patient
The Issue: When Software upgrade 8.1.100 is installed on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper FD20 system with an ADN7NT patient table.
The Issue: When Software upgrade 8.1.100 is installed on an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A610 Clinician Programmer (CP) Software Application (app) with the following
The Issue: Patients implanted with a pocket adaptor (Model 64001
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UPPER EXTREMITY PK
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 - 302497- Procedure tray Catalog Number: ANTK12AF
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: HAND PACK-Procedure Kit Catalog Number: WEHD16B
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 WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
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 SUP JOI PACK Procedure tray Catalog Number: BPAS17C
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: TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
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: HAND PACK-Procedure Kit Catalog Number: WEHD16C
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-Procedure Kit Catalog Number: SLAR14G
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-Procedure Kit Catalog Number: QPKA35A
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 - 247546 Procedure tray Catalog Number: BFTK01Z
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: HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
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 SCOPE Procedure tray Catalog Number: COKN48L
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: QPTK95A
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
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: ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
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: HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B
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: AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number:
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.