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 22261–22280 of 38,428 recalls
Recalled Item: CPT 12/14 COCR SIZE 0 STD prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM PRC LT M/RT L SML FEM PRC RT M/LT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.