FDA recall Z-1944-2026

Milestone S.R.L. · Class II · device

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.

Key facts

Status
Ongoing
Initiation date
2026-03-09
Report date
2026-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sorisole, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1944-2026