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 22281–22300 of 38,428 recalls
Recalled Item: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM
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 GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis
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 PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT 12/14 COCR SIZE 2 EXT 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 FEM IMPLANT SZ H-R This device is indicated for
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION
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 14X160MM STD BODY EXT & 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: CR POR FEM HATCP SIZE E/L SIZE F/L Knee 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 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZIMMER PATELLA FEMORAL JOINT¿ Osteoarthritis
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 SRF HDN FEM SZ D-L LPS PRECOAT SRF
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F
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-R MINUS CR-FLEX OPT FEM D-L MINUS
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 15.0X250MM BWD LT &
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRCT MIS CR MOB PLT SZ 4 L¿ PRCT MIS
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NP FEM LT SZ0 NATURAL-KNE NP FEM RT SZ0 NATURAL-KNE
The Issue: The LDPE bag packaging for various highly polished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.