eakin Cohesive seal — Class III medical device recall Z-3263-2024
Ongoing recall by T.G. Eakin Limited, reported 2024-10-02, distributed in KY. On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 8
| Recall number | Z-3263-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | T.G. Eakin Limited, Comber, Ireland |
| Recall initiated | 2024-08-08 |
| Classified | 2024-09-25 |
| Reported by FDA | 2024-10-02 |
| Distributed | KY |
| UPC / GTIN / UDI-DI | 00768455108732 |
| Lot numbers | 109357C553 |
| Model numbers | 839002 |
Product
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Reason for recall
On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
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-3263-2024. 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.