FDA Medical Device Recalls (openFDA)
Covidien LP: DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048 The ENDO GIA Universal Staplers with DUET TRS Loading Unit 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-3170-2011
- Recalling firm
- Covidien LP
- Product
- DUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048 The ENDO GIA Universal Staplers with DUET TRS Loading Unit 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
- 2011-08-15
- Posted
- 2011-09-08
- Terminated
- 2016-08-24
- Reason
- Sterility of the device is compromised due to a breach in the sterile packaging
- Root cause
- Storage
- Action
- The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 15, 2011, to its customers via federal express. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (Note: Units from the affected lots may have been incorporated into Covidien BEST PRACTICE KITS. If you have purchased BEST PRACTICE KITS, please evaluate whether these kits contain units from the affected lots.); complete and return the DUET TRS Universal Loading Unit Recalled Product Return form via fax to (203) 822-6009; and return all inventory from the affected lots (note: All affected units must be returned) with the complete form to: Field Returns Department, located at 195 McDermott Road, North Haven, CT 06473. Questions or concerns, contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.
- Quantity
- 7842 units
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
- Lot, serial or model codes
- Lot Numbers: H0F0045 N0E0034 N0E0131 N0E0450 N0E0615 N0G0757 N0G0765 N0H0316 N0H0317 N1C0092 N1E0116X N1E0242X N1F0263X N1F0265X N9E0804U N9E0805U N9E0806U N9H0597U N9K0080U N9K0494U N9M0179U N9M0351U
- 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