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 6521–6540 of 38,428 recalls
Recalled Item: PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DUR PCA MTK REV INS RT Intended for knee replacement
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement....
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number:
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part...
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement....
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product...
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product...
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DUR PCA MTK REV INS RT Intended for knee replacement
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.