CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report
Duet TRS 60 Universal Straight Single Use Loading Unit Product recalled
Covidien is recalling Covidien Duet TRS 60 Universal Straight Single Use Loading Unit Product. The recall was initiated on 21 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2436-2012
- FDA event ID
- 63015
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Aug 2012
- FDA classified
- 21 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 21 Aug 2012 | Recall initiated by company | |
| 21 Sep 2012 | Classified by FDA | +31 days |
| 3 Oct 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Product as listed by the FDA
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. 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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Is Duet TRS 60 Universal Straight Single Use Loading Unit Product recalled?
Yes. Covidien recalled Duet TRS 60 Universal Straight Single Use Loading Unit Product on 21 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-2436-2012.
Why was it recalled?
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Which lots are affected?
All lot numbers
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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