FDA Medical Device Recalls (openFDA)
Covidien LP: Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
- Recall number
- Z-1227-2012
- Recalling firm
- Covidien LP
- Product
- Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
- Status
- Terminated
- Initiated
- 2012-02-16
- Posted
- 2012-03-19
- Terminated
- 2021-03-04
- Reason
- Missing component results in the stapler not firing.
- Root cause
- Process control
- Action
- The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at SDFeedback@Covidien.com or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.
- Quantity
- 1158 units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Venezuela.
- Lot, serial or model codes
- Lot Number: N1H0037LX
- 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