← FDA ENFORCEMENT
Z-1944-2026Class II

Milestone S.R.L.

Recalling firm
Milestone S.R.L.
Product type
Device
Status
Ongoing
Report date
2026-05-06
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Product quantity
61600 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

UDI-DI: 08052478981055; Lot Number: 2024-09

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.