Endo GIA Auto Suture Universal Articulating Loading Unit for use in… — Class II medical device recall Z-0636-2018
Terminated recall by Covidien LLC, reported 2018-02-28. Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loadin
| Recall number | Z-0636-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2017-09-13 |
| Classified | 2018-02-16 |
| Reported by FDA | 2018-02-28 |
| Terminated | 2019-06-28 |
| Quantity | 3,816 |
Product
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason for recall
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
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-0636-2018. 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.