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 26421–26440 of 38,428 recalls
Recalled Item: HexaPOD evo RT System Product Usage: The intended use of
The Issue: Potentially unrecognized incorrect position of the treatment couch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System Used to make treatment plans for patients
The Issue: In a specific workflow where contours are edited
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIO-A / NIO-P is an instant IO access device comprises
The Issue: WaisMed received a report in which during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sagittal Blade 18.0X0.97X90MM
The Issue: Stryker Instruments is voluntarily recalling the Sagittal Blade
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD)
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pathfast D-Dimer
The Issue: Two complaints were received about decrease in sensitivity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small.
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Colonoscope is intended to be used with a
The Issue: Pentax is initiating the product correction of several
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Video Gastroscope is intended to be used with a
The Issue: PENTAX Medical is initiating this field action to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific QMS Everolimus Assay
The Issue: A reagent stability issue (still under investigation) causes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BruxZir Shaded
The Issue: Prismatik Dentalcraft is recalling BruxZir Shaded because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARTO 3 EP Navigation System and Accessories
The Issue: Biosense Webster, Inc. is initiating a voluntary correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vertebral Motion Analyzer (VMA)
The Issue: Ortho Kinematics, Inc. notified customers of erroneous results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Fluid Management Set
The Issue: Merit Medical Systems, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex Suture Washer
The Issue: The device was assembled incorrectly. Suture and washer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a
The Issue: Post Market Surveillance cases reported to Maquet showing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon
The Issue: Sorin Group USA, Inc. announces a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The
The Issue: The tip of the cannula should be bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027
The Issue: A defect component of the Compano reader power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaPACS versions 8.4.7
The Issue: Novarad Corporation announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.