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 181–200 of 38,428 recalls
Recalled Item: Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WB Impression Post Closed Tray incl. guide screw
The Issue: The mix up of the impression caps provided
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMSAFLEX M100 SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX ST100 SET US
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OXIRIS SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX M150 SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX TPE2000 SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX HF1000 SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX ST150 SET US
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRISMAFLEX HF1000 SET
The Issue: There is a potential dislodgement of the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Raz-AT (Attendant Tilt) Mobile Shower Commode Chair
The Issue: Due to a modification by a vendor and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) NAIL KIT
The Issue: Medline has identified that the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meijer STERILE saline wound wash
The Issue: Medline has identified that the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile Saline Wound Wash
The Issue: Medline has identified that the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION
The Issue: Medline has identified that the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits: 1) NAIL KIT
The Issue: Medline has identified that the manufacturer of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.