Coviden EEA Circular Stapler Recalled for Potential Tissue Gap Defect
Coviden is recalling 1,902 EEA Circular Staplers with Tri-Staple Technology due to a potential defect that may cause incomplete staple formation or device retention in tissue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical device where the defect could lead to significant harm (bleeding, anastomotic leak, tissue trauma), but the source explicitly states there have been no reports of serious injury, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Coviden LLC is recalling 1,902 units of the EEA Circular Stapler with Tri-Staple Technology (Part Nos. TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, TRIEEA31XT). The device is used to place circular, triple staggered rows of titanium staples and resect excess tissue to create a circular anastomosis.
The recall was initiated because the firm identified a potential for the device to have an incorrect tissue gap. Use of a device with this defect may result in incomplete staple formation and/or the inability to remove the device from tissue following application. This could potentially lead to bleeding, anastomotic leak, or tissue trauma. The FDA has classified this as a Class II recall, and there have been no reports of serious injury related to this issue.
The affected units were distributed worldwide, including nationwide in the United States (specifically in CA, FL, IL, NC, NY, and UT) and in various countries in Europe. Healthcare providers and facilities should check their inventory for the specific lot codes listed in the recall notice and stop using any affected devices. Consumers are not expected to have these devices in their homes, as they are surgical instruments intended for professional medical use.
The recalled product
- Product
- EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a…
- Manufacturer
- COVIDIEN LLC
- Affected units
- 1,902
Distribution
Related recalls
Same manufacturer · COVIDIEN LLC
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · incomplete staple formation
See all →- SevereFDA Recalls Covidien TA Auto Suture Vascular Staplers Due to Damaged Components
FDA (Devices) · 2021-01-06
- SevereFDA Recalls Covidien TA Auto Suture Vascular Loading Units
FDA (Devices) · 2021-01-06
- SevereFDA Recalls Endo GIA Auto Suture Units Due to Staple Formation Defects
FDA (Devices) · 2020-10-07
- HighEndo GIA Auto Suture Universal Loading Unit Recall for Staple Formation Defect
FDA (Devices) · 2020-10-07
- HighEndo GIA Auto Suture Universal Articulating Loading Unit Recall
FDA (Devices) · 2020-10-07
Similar recalls
- HighEEA Autosuture Circular Staplers Recalled for Staple Guide Detachment Risk
FDA (Devices) · 2022-07-13
- HighRecall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect
FDA (Devices) · 2018-05-02
- HighEEA Hemorrhoid Stapler Recalled for Potential Welding Defect
FDA (Devices) · 2018-05-02
- SevereFDA Recalls 3.1 Million Covidien Surgical Staplers Due to Missing Pins
FDA (Devices) · 2019-06-26
- SevereFDA Recalls 3.1 Million Covidien EGIA 45 Articulating Xtra Thick Sulu Devices
FDA (Devices) · 2019-06-26
- SevereCovidien EGIA 60 Curved Tip Surgical Stapler Recall for Missing Pins
FDA (Devices) · 2019-06-26