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 10741–10760 of 38,428 recalls
Recalled Item: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter
The Issue: Devices were manufactured with a "First Use Date"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic IN.PACT AV
The Issue: Packaging for Balloon Catheters may be damaged resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic IN.PACT Admiral
The Issue: Packaging for Balloon Catheters may be damaged resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TearCare version 1.0 SmartHubs
The Issue: Ophthalmic devices distributed prior to the recently-obtained 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5
The Issue: Product not approved for release for US distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2
The Issue: Product not approved for release for US distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACS Cath Lab Pack
The Issue: Product was sterilized with a higher than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACS Lap Chole Pack
The Issue: Product was sterilized with a higher than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
The Issue: Product was sterilized with a higher than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
The Issue: Product was sterilized with a higher than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACS IR - Angio Pack
The Issue: Product was sterilized with a higher than specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inactivated macrolide-resistant Mycoplasma genitalium
The Issue: The QC process was not adequate for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restrata
The Issue: Misprinted expiration date on the shelf-box
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avanos Cortrak 2 Enteral Access System (EAS)
The Issue: Product labeling is being modified. STOP using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prevantics swabs and/or swabsticks contained inside the following Aligned...
The Issue: Convenience kits contain one or more swab/swabstick drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard brand CABG Pack A and B - Spartanburg
The Issue: Kits were packed into shipping boxes incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WAVES WCM Kidney Cassette Module
The Issue: There is a potential for the WCM cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS
The Issue: Ventilator mounting brackets for the Vivo 50/60/65 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIA Radiation Therapy Management (RTM) VERSIONS 13.6
The Issue: Software issue for treatment plan and image management
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A
The Issue: Wrong compression material - Template Ultra Quick matrix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.