FDA Device recall Z-2641-2024
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)
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of 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) by Microtek Medical, citing during sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2641-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-03 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microtek Medical |
| Distribution | US |
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
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Identifiers
| code_info | SKU/UDI-Device Identifier: 2004S/00748426002498; Lot Numbers: 200328,220321,220321,221220,221220,221102,220321,181127,2…SKU/UDI-Device Identifier: 2004S/00748426002498; Lot Numbers: 200328,220321,220321,221220,221220,221102,220321,181127,220321,210506,200328,181127,200328,181127,181127,181127,200328,200328,180625,191113,220321,220321,220321,220321,210506,210506,210109,191113,200328,201115,200328,181127,181127,200328,181127,181127,181127,210506,191113,191113,180625,181127,221220,221102,220321,181127,220321,210506,210506,191113,200328,220321,220321,220321,200328,220321,220321,210506,210506,221220,221102,220321,180625,210109,191113,181127,210506,210506,181127,200328,200328,180625,180625,180625,181127,181127,180625,200328,191113,191113,181127,191113,200328,200328,220321,220321,220321,210506,210506,210506,210506,210109,200328,200328,200328,200328,200328,200328,200328,191113,181127,181127,200328,181127,181127,181127,181127,181127,200328,191113,191113,181127,180625,181127,221220,200328,181127,181127,200328,220321,220321,200328,210506,210506,210506,210506,210109,210109,201115,191113,200328,200328,200328,200328, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2641-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.