Endo GIA Auto Suture Universal Loading Unit — Class II medical device recall Z-0007-2021
Ongoing recall by Covidien, LP, reported 2020-10-07, distributed nationwide. The device staples may not properly form upon application preventing adequate hemostasis. Use of a product wit
| Recall number | Z-0007-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien, LP, North Haven, CT, United States |
| Recall initiated | 2020-08-12 |
| Classified | 2020-10-01 |
| Reported by FDA | 2020-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 900,007 total |
| Lot numbers | T0A104X, T0C041X, T0C042X, T7F018X, T7F023X, T7F024X, T7J006X, T7J011X, T7J012X, T7K030X, T7K031X, T7K032X, T7K033X, T7L042X, T7L043X, T7L044X, T7L045X, T7L046X, T7L047X, T8A005X, T8A006X, T8A041X, T8A042X, T8C039X, T8C040X, T8D055X, T8D056X, T8E053X, T8E054X, T8F041X, T8F042X, T8F043X, T8F075X, T8J011X, T8K063X, T8L028X, T8L029X, T8L030X, T8L031X, T8L032X and 25 more |
| Model numbers | 030457 |
Product
Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason for recall
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
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-0007-2021. 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.