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 7021–7040 of 38,428 recalls
Recalled Item: VERIQUICK PREGNANCY TEST 1CT
The Issue: Products were stored outside of labeled temperature requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HILLROM PROGRESSA+ BED
The Issue: Progressa+ beds have the potential for static buildup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tina-quant D-Dimer Test System
The Issue: Elevated results were detected with Li-heparin plasma samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edge Biologicals STERILE WATER
The Issue: Due to product outer packaging incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX Revolution Mobile X-Ray System
The Issue: Unexpected failure of electrical components within the CPI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT-Site M BHB Test Strips
The Issue: Deterioration in the stability of the Test Strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Gastrointestinal Videoscope
The Issue: Sterilization failures when devices are sterilized per the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray
The Issue: There is a potential for unexpected failure of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coapt Dome Electrode
The Issue: Patient may experience minor burn or blistering if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coapt ControlSeal Electrode
The Issue: Patient may experience minor burn or blistering if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO +VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO VISIAN Implantable Collamer Lens .2. Phakic Intraocular lens.
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Firm PVC Thoracic Catheter 36FR Straight
The Issue: A sterilization nonconformance prematurely aged the product, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO+VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVO VISIAN Implantable Collamer Lens
The Issue: Their is a potential that intraocular implant devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.