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 29141–29160 of 38,428 recalls
Recalled Item: RotaWire Elite and wireClip Torquer
The Issue: Boston Scientific is recalling its recently released RotaWire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RotaWire Elite and wireClip Torquer
The Issue: Boston Scientific is recalling its recently released RotaWire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: miraDry System consisting of the MD4000-MC Console
The Issue: Update to labeling for the miraDry Console to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Extension Set
The Issue: CareFusion is recalling the SmartSite Extension Set due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OrthoCase software. The firm name on the label is Merge Healthcare
The Issue: Measurements in the software are changing after saving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Easy Dial Oxygen Regulator
The Issue: These lots of Oxygen Dial Regulators could have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti...
The Issue: The Synthes SNTRP set was released for sale
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in...
The Issue: Reports of catheter tip splits and or separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry XPT Systems
The Issue: Multiple Software issues. Auto Start-UP Fail, Calibration Interval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator
The Issue: Certain Model 106 Pulse Generators demonstrate delays in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
The Issue: Hill-Rom is voluntarily recalling the Hill-Rom 100 Low
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helioseal F Sealant 1 x 1.25 g
The Issue: A defect occurred in the production process of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides
The Issue: Siemens will provide all customers a new version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold
The Issue: The affected part number and lot listed above
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm.
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter 15L Cycler Drainage Bag Sterile
The Issue: Leakage from the inlet port of the 15L
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience Kits
The Issue: Avid Medical Inc. states a latex-containing Telfa" Non-adherent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PEDIATRIC KIDNEY BIOPSY TRAY
The Issue: Avid Medical Inc. states a latex-containing Telfa" Non-adherent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convenience Kits
The Issue: Avid Medical Inc. states a latex-containing Telfa" Non-adherent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAMMOGRAPHY
The Issue: Avid Medical Inc. states a latex-containing Telfa" Non-adherent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.