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 17841–17860 of 38,428 recalls
Recalled Item: Monoject Standard Hypodermic Needle
The Issue: Manufacturing defect was found for the cartridge component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject Standard Hypodermic Needle
The Issue: Manufacturing defect was found for the cartridge component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject" 201 Vet Pak Hypodermic Needle
The Issue: Manufacturing defect was found for the cartridge component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject Blunt Cannula
The Issue: Manufacturing defect was found for the cartridge component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac EPF/EGR Hook/Triangle Blade Kit
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endotrac ECTR Hook/Triangle Blade Kit
The Issue: The seal integrity of the sterile bag containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0:
The Issue: There is a potential that the image of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR and Argyle acute hemodialysis catheters
The Issue: The priming volume values printed on the MAHURKA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliBridge System configured with a regional setting which uses
The Issue: Infusion Pump Data Storage Accuracy-Data from the BBraun
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Patient Information Center iX configured with a regional setting
The Issue: Infusion Pump Data Storage Accuracy-Data from the BBraun
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEXIS Titanium Intraoral Sensor Product Usage: The DEXIS Titanium Intraoral
The Issue: The sensor's look up calibration files were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inovo Single Luman Conserver Product Usage: This device is intended
The Issue: The pressure gauge (manometer) may dislodge from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquarius D13S319 Plus Deletion Probe
The Issue: There is an error in the chromomap on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zenith Alpha Abdominal Endovascular Graft
The Issue: may contain a damaged gray safety lock knob,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ThermaCare HEATWRAPS
The Issue: There is the potential that a HeatWrap could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOLOPATH Balloon Expandable TransFemoral System
The Issue: There is a potential for dislodgement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opteform Allograft Disc
The Issue: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opteform Allograft Disc
The Issue: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Opteform Allograft Disc
The Issue: The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portico Solo Re-Collapsible Access System
The Issue: There is a potential for dislodgement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.