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 35461–35480 of 38,428 recalls
Recalled Item: 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597102010 Provisional CR ART SURF PROV 12/PURPLE 10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597502010 Provisional AC ART SURF PROV 12/PUR 10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597602010 Articular Surface AC ART SURF 12/PUR 10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597201303 Femur CR POR FM COMP SIZE CML Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597202009 Articular Surface CR ART SURF 12/PURPLE 09
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 65597201333 Femur CR POR FEM SURF HDN HATCP CML
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00587806126 Patella MICRO POROUS PAT 26MM X 10MM
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00595201201 Femur CR-FLEX POR FEM B-L Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00595001201 Femur CR-FLEX PCT FEM B-L Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597001131 Femur CR PRC SURF HDN FEM CO-NID AML
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.