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 27241–27260 of 38,428 recalls
Recalled Item: BIOGRAPH mCT Flow Edge-3R
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 16 TruePoint TV
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOGRAPH 40 - 3 Ring
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOGRAPH 40 TruePoint
The Issue: Siemens Medical Solutions, Molecular Imaging has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioSync Anatomic Cotton Wedge
The Issue: for polystyrene particulate presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD Administration Sets with Flow Stop
The Issue: Smiths Medical became aware that under delivery of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model
The Issue: The replacement HEPA Filters have been manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accriva- APTT Cuvette for use on the Hemochron Jr. test system
The Issue: Clot activating reagent mis-positioned or visibly absent in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Streamline OCT Occipito-Cervico-Thoracic System
The Issue: for a product defect where the cannula
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Musculoskeletal Transplant Foundation
The Issue: AFT Diverted Tubes are being recalled due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Red Head 2 Reusable Fat Harvesting Canister
The Issue: During an FDA inspection it was found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and
The Issue: Operators noticed unwanted release of evaporating anesthetic agent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM(TM)
The Issue: Instructions for use booklet may puncture the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM(TM)
The Issue: Instructions for use booklet may puncture the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEM(TM)
The Issue: Instructions for use booklet may puncture the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.