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 10681–10700 of 38,428 recalls
Recalled Item: Sara Plus Active Floor Lift
The Issue: The device may emit smoke or ignite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP
The Issue: Heater within the Verigene System may be outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The following first aid kits and cabinets containing components Medi-First
The Issue: First aid kit and cabinet components are being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diagnostic Kit SARS-cCo V Antigen Rapid Test
The Issue: COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbett Surgical Container
The Issue: Eight units manufactured before June 2019 have exhibited
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS...
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA...
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 9100-Series Washer Disinfector models: 9120E
The Issue: Inadequate documentation verifying whether device installation has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITRIGUARD
The Issue: Products in this lot may have compromised barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CYSTO-URETHRO-FIBERSCOPE CYSTOSCOPE
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC...
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA...
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11001RD1 11001RDK1 KARL STORZ Slim Nasopharyngolaryngoscope 96216006US V5.0...
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11272VN 11272VNK Flexible Video Urethro Cystoscope Z18442US-BD (08/2018)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016)
The Issue: Failure to achieve the expected six-log reduction in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular
The Issue: There is a potential for foreign matter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.