EEA Circular Stapler with Tri-Staple Technology — Class II medical device recall Z-0070-2019
Terminated recall by COVIDIEN LLC, reported 2018-10-10, distributed nationwide. The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorr
| Recall number | Z-0070-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | COVIDIEN LLC, Mansfield, MA, United States |
| Recall initiated | 2018-08-17 |
| Classified | 2018-10-04 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2020-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, DE, DK, ES, FI, FR, GB, IS, IT, LV, NL, NO, PL, PT, SE |
| Quantity | 1,902 |
| Reason classes | packaging |
| Model numbers | TRIEEA28MT, TRIEEA28XT, TRIEEA31MT, TRIEEA31XT |
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 circular anastomosis.
Reason for recall
The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.
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-0070-2019. 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.