Entuit Secure Gastrointestinal Suture Anchor Set — Class II medical device recall Z-0968-2019
Terminated recall by Cook Inc., reported 2019-03-06, distributed nationwide. There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a sp
| Recall number | Z-0968-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2018-12-19 |
| Classified | 2019-02-28 |
| Reported by FDA | 2019-03-06 |
| Terminated | 2020-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, DE, DK, ES, FR, GB, HU, IS, IT, NL, NO |
| Quantity | 975 |
| Lot numbers | 8056941, 8135292, 8165522, 8228910, 8261265, 8293447, 8331165, 8357394, 8389427, 8395982, 8445405, 8471250, 8483543, 8511203, 8556989, 8557006, 8564659, 8622758, 8628912, 8663134 |
| Model numbers | GIAS-SRM-3 |
Product
Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Order Number G35570 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters.
Reason for recall
There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
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-0968-2019. 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.