Recall archive / FDA device enforcement
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal — FDA record Z-3263-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
- Reason
- On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
- Classification
- Class III
- Recalling firm
- T.G. Eakin Limited
- Quantity
- 35,400 cartons of 20 individually packaged seals
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3263-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00768455108732, Lot number 109357C553 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: KY
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 2, 2024
- Recall initiation date
- Aug 8, 2024
- Center classification date
- Sep 25, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.