Events

Recall of Device Recall Endopath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon Endo-Surgery 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
    Recall
  • Event ID
    76921
  • Event Risk Class
    Class 2
  • Event Number
    Z-2174-2017
  • Event Initiated Date
    2017-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154570
  • 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
    Staple, implantable - Product Code GDW
  • Reason
    There is a risk that the pinion gear in the device could fail under extreme use cases.
  • Action
    Consignees were sent notification letters and were asked to complete the Business Reply Form (BRF).

Device

Device Recall Endopath
  • Model / Serial
    N91U0W, N91U0X, N91L2P, N91N1J, and N91N2G
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. The previously recalled products were distributed to the following countries: China, Japan, Singapore, and South Korea.
  • Product Description
    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • Manufacturer Address
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Blue Ash OH 45242-2803
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA