VACUUM BAG SU LARGE — Class II medical device recall Z-1944-2026
Ongoing recall by Milestone S.R.L., reported 2026-05-06, distributed nationwide. There is a possibility of reagent leakage from the specimen container.
| Recall number | Z-1944-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Milestone S.R.L., Sorisole, Italy |
| Recall initiated | 2026-03-09 |
| Classified | 2026-04-24 |
| Reported by FDA | 2026-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CL, ES, FR, GB, GR, IL, IT, LU, NL, PT, SE |
| Quantity | 61,600 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08052478981055 |
| Lot numbers | 2024-09 |
| Model numbers | 68409SS |
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Reason for recall
There is a possibility of reagent leakage from the specimen container.
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-1944-2026. 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.