Bottle Decanter — Class II medical device recall Z-2641-2024
Ongoing recall by Microtek Medical Inc., reported 2024-08-28, distributed nationwide. During sterile barrier testing performed on the decanter product line, the samples were identified to have pin
| Recall number | Z-2641-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microtek Medical Inc., Saint Paul, MN, United States |
| Recall initiated | 2024-06-03 |
| Classified | 2024-08-16 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BZ, CA, HK, MX, NZ |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00748426002498 |
| Lot numbers | 180625, 181127, 191113, 200328, 201115, 210109, 210506, 220321, 221102, 221220 |
| Model numbers | 2004S |
Product
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Reason for recall
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
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-2641-2024. 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.