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 6541–6560 of 38,428 recalls
Recalled Item: Scorpio NRG Tibial Brg Insert Assy -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 Product...
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 TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510
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 TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -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: Scorpio NRG Tibial Brg Insert Assy -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: 72-4-7518
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 replacment Part Number: 72-4-7516
The Issue: Product manufactured using UHMWPE raw material over 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LARGE PRIMARY REV.TIB.INSERT- 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: SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
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: DURATION A-P LIPPED TIB.INSERT-DURAC 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: Vasoview Hemopro Endoscopic Vessel Harvesting System
The Issue: Risk of polyimide particulate matter being present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vasoview Hemopro Endoscopic Vessel Harvesting System
The Issue: Risk of polyimide particulate matter being present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bkActiv Ultrasound System 2300
The Issue: An issue on the Dual Live Compare feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Link Patella Glide Resection Guide- For the implantation of the
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GammaPod - Treatment Planning System-a component of the GammaPod Irradiation
The Issue: Wrong structures imported into the GammaPod Treatment Planning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT 7500
The Issue: Multiple software issues that affect device functionality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.