Class II — Milestone S.R.L.
| Recalling firm | MILESTONE S.P.A. |
|---|---|
| Registered facility | MILESTONE S.P.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a possibility of reagent leakage from the specimen container. |
| Product | VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS |
| Quantity | 61600 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden. |
| Initiated | 2026-03-09 |
| Classified | 2026-04-24 |
| Recall number | Z-1944-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Milestone S.R.L. (Z-1944-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98632/
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