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 12601–12620 of 38,428 recalls
Recalled Item: ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for
The Issue: One batch of the ELUVIATM Drug Eluting Vascular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in...
The Issue: The lot may have experienced an anomaly during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta MOSAIC Oncology Information System versions: 2.62
The Issue: Malware attack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multitom RAX with software version VF10
The Issue: Siemens identified two issues, In some cases, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Logical cup liner - Product Usage: intended to replace a
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alpha Interlock Suspension System Lanyard Body: An external prosthetic device.
The Issue: the firm discovered that, starting on April 1,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Econocare Plus Waffle Overlay- Intended for use as a medical
The Issue: Product contamination-a trace amount of dried bodily fluids
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Case Cardiac Assessment System for Exercise Testing and CardioSoft Diagnostic
The Issue: If a certain sequence of events occur, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova IGS 3 (GTIN 00840682147378)
The Issue: The IGS system can experience a single vertical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Enterprise Viewer - Product Usage: intended to be
The Issue: A software defect was identified where the Image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES HSV 1&2 Assay
The Issue: Impacted lot may leak inside the ARIES instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
The Issue: Malfuncton-Implant did not deploy successfully may necessitate the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
The Issue: Malfuncton-Implant did not deploy successfully may necessitate the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel (Penumo)
The Issue: Elevated rates of false positive/false negative and control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
The Issue: Instruments were assembled and serviced using a defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Critical Care Ventilator
The Issue: Three separate and unrelated problems attributed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Critical Care Ventilator
The Issue: Three separate and unrelated problems attributed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sarns TCM II (system) is a source of temperature-controlled
The Issue: Terumo CVS has been unable to validate a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Critical Care Ventilator
The Issue: Three separate and unrelated problems attributed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sarns Temperature Control and Monitor unit (TCM) is a
The Issue: Terumo CVS has been unable to validate a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.