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 33541–33560 of 38,428 recalls
Recalled Item: Stryker PenAdapt"
The Issue: During packaging verification testing, a failure occurred due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IPM Wound Gel Rx Wound Dressing IPM Wound Gel is
The Issue: for microbial contamination of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATEX-FREE
The Issue: The Tyvek cover may not be completely sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATEX-FREE
The Issue: The Tyvek cover may not be completely sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATEX-FREE
The Issue: The Tyvek cover may not be completely sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATEX-FREE
The Issue: The Tyvek cover may not be completely sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LATEX-FREE
The Issue: The Tyvek cover may not be completely sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlloFuse DBM Putty 5cc
The Issue: The donor was hemodiluted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500
The Issue: Serum controls may go out of range low
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable latex breathing bags with multiple part numbers and sold
The Issue: Reusable latex breathing bags with various part numbers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spirit MB Bracket
The Issue: Ormco Corporation initiated this recall of Spirit MB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium Orthos Brackets
The Issue: Ormco Corporation inititated recall of U2R Titanium Orthos
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AxoTrack I Sterile Procedure Kit 18G
The Issue: There is a possibility the sterile packaging may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue
The Issue: Kits are packaged with the incorrect catheter. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Wound Dressing 1 oz. tube
The Issue: Product may not have been manufactured pursuant to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Wound Dressing 55 gallons/drum
The Issue: Product may not have been manufactured pursuant to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D
The Issue: While projecting yellow lines it was notice that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SOMATOM Emotion 16
The Issue: The rubber damper may degrade and break, causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope System 98/98xt
The Issue: mechanical failure of the fan assembly associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stirling Ultracold Portable Shuttle
The Issue: The external power supply input is overheating at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.