VACUUM BAG SU LARGE recall (Milestone S.R.L.)
Medical deviceClass IIOngoing
Summary: Milestone S.R.L. is recalling VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS. Reason: There is a possibility of reagent leakage from the specimen container.
What is being recalled
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Why
There is a possibility of reagent leakage from the specimen container.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
How to tell if yours is affected
UDI-DI: 08052478981055; Lot Number: 2024-09
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1944-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 9, 2026 |
| Reported | May 6, 2026 |
| Company | Milestone S.R.L. |
| Company location | Sorisole, Italy |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 61600 units |
More recalls from Milestone S.R.L. · all medical device recalls · recalls from March 2026