Recall of Tissuelink Dissecting Sealer DS3.5-C, Sterile || Ref 13-121-1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TissueLink Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Reason
    The tip may separate from the device and render it unusable.
  • Action
    TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.


  • Model / Serial
    Lot Number: TL033300
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    AZ, CA, CO, CT, DE, IL, FL, KS, KY, OH, MA, MD MO,NC, NY, PA, RI, SC, TN,TX, VA Foreign: Italy, Turkey, Egypt, Spain, Peru, Portugal, Australia, Netherlands Government: VA Medical Center 508 Fulton Street Durham, NC 27005 VA Medical Center- 7400 Merton Minter Blvd San Antonio, TX 78229 VA Medical Center- Pittsburgh University C Pittsburgh, PA 15240
  • Product Description
    Tissuelink Dissecting Sealer DS3.5-C, Sterile || Ref 13-121-1
  • Manufacturer


  • Manufacturer Address
    TissueLink Medical, Inc., One Washington Center, Suite 400, Dover NH 03820
  • Source