FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and the source text explicitly states the device may result in 'life threatening post-operative complications,' which aligns with the rubric criteria for Severe (score 4) involving significant injury reports or high-risk medical device defects.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit (Product Code: DUET4548A). The recall affects 104,355 units distributed worldwide. This medical device is a single-use loading unit tissue reinforcement stapler used in abdominal, gynecologic, and pediatric surgery for resection, transection, and the creation of anastomoses.
The recall was initiated because the Duet TRS device has the potential to injure adjacent anatomical structures. According to the FDA, this risk may result in life-threatening post-operative complications. The recall covers all lot numbers of the affected product.
Healthcare facilities and consumers who have this product should stop using it immediately. Users should contact the recalling firm, Covidien LP, for further instructions on how to return or dispose of the device. The FDA advises that this recall is a Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
- Manufacturer
- Covidien LP
- Affected units
- 104,355
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lot numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 8 recalled by Covidien LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Covidien LP
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSurgipro II Sutures Recalled for Potential Sterile Barrier Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
Same hazard · surgical injury
See all →- HighSTERIS Boot Assembly, Traction Device Recalled Due to Locking Pin Detachment Risk
FDA (Devices) · 2024-03-20
- HighIn2Bones Shannon Percutaneous Burr Recalled for Potential Breakage During Use
FDA (Devices) · 2021-03-31
- HighSmith & Nephew Recalls Journey II Uni Resection Prep Trial Instruments
FDA (Devices) · 2020-06-03
- SevereK2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk
FDA (Devices) · 2020-05-27
- SevereK2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
FDA (Devices) · 2020-05-27