FDA Medical Device Recalls (openFDA)
Covidien LLC: LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
- Recall number
- Z-2427-2018
- Recalling firm
- Covidien LLC
- Product
- LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
- Status
- Terminated
- Initiated
- 2018-03-15
- Posted
- not on file
- Terminated
- 2019-12-11
- Reason
- Devices were found with a sterile breach (puncture) in the pouch from a sort of 8,064 packaged devices.
- Root cause
- Other
- Action
- Medtronic Regional sent a notification letter to customers via overnight delivery. the letter identified the affected product, problem and actions to be taken. The letter request that you quarantine and return any unused products of the affected item codes and production lots. Unused products from the affected item codes should be returned. If you have distributed Covidien LigaSure" Exact Dissector listed, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes must be returned. The potentially affected product was shipped to your facility between November 2017 and February 2018.
- Quantity
- 936
- Distribution
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Saudi Arabia, Spain, Swede, Switzerland and United Kingdom
- Lot, serial or model codes
- Lot #s 72550127X 72770140X 72770141X 73000048X
- 510(k) numbers
- ["K150091"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28