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 12581–12600 of 38,428 recalls
Recalled Item: Sapi Med sterile disposable colorectal anoscopes and proctoscopes....
The Issue: Due to issue with product sterility. Sterilization service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X - Model Number: 781356
The Issue: The MR magnet is equipped with 4 lifting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.
The Issue: The MR magnet is equipped with 4 lifting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Ultem Polymeric Resin Koh Cup is a non- sterile
The Issue: The affected Koh Cup were incorrectly packaged with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall
The Issue: Risk of fluid ingress to the power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProBP 3400 Digital Blood Pressure Device ((handheld
The Issue: Risk of fluid ingress to the power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuroTherm NT2000iX Radiofrequency (RF) Generator
The Issue: capacitor failure which typically manifests as in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin
The Issue: The media allows growth of E. faecalis ATCC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPTAR Laser Range Finders
The Issue: RAPTAR units are capable of being field modified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Semi-automatic Biopsy-Needle
The Issue: Sterility Assurance; Coaxial Interventional Needle labeled as sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coaxial Interventional Needle
The Issue: Sterility Assurance; Coaxial Interventional Needle labeled as sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coaxial Interventional Needle
The Issue: Sterility Assurance; Coaxial Interventional Needle labeled as sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydrodissection Cannula (Chang)
The Issue: The product may have a yellowish-brown/greenish-brown residue present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24
The Issue: Evaluation of a clinical goal for the voxelwise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIA Microcatheter VIA 21 - Product Usage: is
The Issue: Due to inadvertently shipping to U.S. customers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIA Microcatheter VIA 17 - Product Usage: is
The Issue: Due to inadvertently shipping to U.S. customers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIA Microcatheter VIA 27 - Product Usage: is
The Issue: Due to inadvertently shipping to U.S. customers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rubber Dam Clamp
The Issue: Removing parts for safety reasons due to possible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical Video Duodenoscope - Product Usage: intended to be
The Issue: IFU updated: The warning section of the IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centaur Syphilis Assay-SYP Kit
The Issue: for the ADVIA Centaur Syphilis assay to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.