Covidien Duet TRS 60 4 — Class II medical device recall Z-2438-2012
Terminated recall by Covidien LP, reported 2012-10-03. Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening
| Recall number | Z-2438-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, North Haven, CT, United States |
| Recall initiated | 2012-08-21 |
| Classified | 2012-09-21 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2016-08-30 |
| Quantity | 15,936 units |
Product
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Reason for recall
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2438-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.