FDA Medical Device Recalls (openFDA)
Covidien LP: DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
- Recall number
- Z-0995-2012
- Recalling firm
- Covidien LP
- Product
- DUET TRS 60 3.5MM STRAIGHT SULU Product Code: DUET6035 Product Usage: The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
- Status
- Terminated
- Initiated
- 2012-01-12
- Posted
- 2012-02-13
- Terminated
- 2016-08-24
- Reason
- Duet TRS Straight and Articulating Single Use (SULU)Loading Staplers used in thoracic surgery may result in serious injury or death
- Root cause
- Under Investigation by firm
- Action
- Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.
- Quantity
- 12,961 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- ["K080898"]
- PMA numbers
- not on file
- Product code
- GDW
- 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