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 13821–13840 of 38,428 recalls
Recalled Item: Sentinel V10.x & V11.x
The Issue: During system upgrade incorrect comments may be added
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Implantable Cardioverter Defibrillators with Cardiac...
The Issue: Manufacturing error that may have resulted in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch
The Issue: RevMedX Trauma Dressing is being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCEL ELISA COVID-19 for the detection of total antibodies to
The Issue: Emergency Use Authorization (EUA) removed from list of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal
The Issue: All-in-One Tab Removal Tool may cause cracking and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannulated graduated drill bit 1.9 mm diameter
The Issue: Traces of corrosion on the laser marking was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof...
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Andorate Disposable Endoscope Valves Set-5-piece Valve
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R...
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Andorate Disposable Endoscope Valves Set-Contains Suction
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bulldog Disposable Endoscope Valves Set-Air/Water Valve
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bulldog Disposable Endoscope Valves Set-Air/Water Valve
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY...
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STOPCON Disposable Valves Set-Single Use Valves...
The Issue: Suction button is reported sticky and/or broken during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4
The Issue: This is a follow-up to the EKOS Field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kowa VK-2s software Version 10.0.4.0
The Issue: It has been determined that the software distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product
The Issue: Shafts do not pass through the inner cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.