FDA Medical devices recall ·
VACUUM BAG SU LARGE, Non-sterile specimen container, Model recall
- Recall number
- Z-1944-2026
- Date
- (initiated March 9, 2026)
- Company / brand
- Milestone S.R.L.
Via Fatebenefratelli 1/5, Sorisole, Italy - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 61600 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Why was it recalled?
There is a possibility of reagent leakage from the specimen container.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 08052478981055; Lot Number: 2024-09
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1944-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.