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 6481–6500 of 38,428 recalls
Recalled Item: Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm)
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover URINE METER ADD-A-FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" 100% SILICONE FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive SuperPulsed Laser System TFL Fiber Stripper
The Issue: The strippers and cleavers are provided non-sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLTIVE SuperPulsed Laser Fibers
The Issue: Affected products may potentially have a breached sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive SuperPulsed Laser System TFL FIBER CLEAVER
The Issue: The strippers and cleavers are provided non-sterile and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-V2
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-VH
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-VHR
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. BF-XP190
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-V2R
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-5R
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. BF-P190
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. CYF-5
The Issue: Olympus has updated the instructions for use: Reusable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model No. ENF-XP
The Issue: Olympus has updated the instructions for use: Reusable
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: 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: 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 TOTAL KNEE MEDIALIZED 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: LEFT SMALL-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.