Medical device recalls Moderate risk

VACUUM BAG SU LARGE recalled over sterility concerns

Recall date
March 9, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Milestone S.R.L. recalls VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Recall number
Z-1944-2026
FDA classification
Class II
Brand / firm
Milestone S.R.L.
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.

Why it was recalled

There is a possibility of reagent leakage from the specimen container.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

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