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CLASS II · ModerateFDA

Milestone S.R.L. recalls VACUUM BAG SU LARGE

📅 Mar 9, 2026 · 📍 Nationwide
Recalling company
Milestone S.R.L.
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Reason
There is a possibility of reagent leakage from the specimen container.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 9, 2026
Reported
May 6, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Status
Ongoing
Quantity
61600 units
Lot / codes
UDI-DI: 08052478981055; Lot Number: 2024-09
Company location
Sorisole
Recall type
Voluntary: Firm initiated
Recall number
Z-1944-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1944-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.