# FDA recall Z-3263-2024

> **T.G. Eakin Limited** · Class III · device recall initiated 2024-08-08.

## 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.

## Distribution

US:  KY

## Key facts

- **Recall number:** Z-3263-2024
- **Recalling firm:** T.G. Eakin Limited
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-08
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Comber, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3263-2024

## Citation

> AI Analytics. FDA recall Z-3263-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-3263-2024. Source: US FDA. Licensed CC0.

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