FDA recall, , Moderate risk
Milestone Vacuum Bag SU Large Specimen Containers
The non-sterile specimen container may have reagent leakage.
Summary by Recall Canary from the FDA notice
What happened
Milestone S.R.L., based in Sorisole, Italy, began a recall of its Vacuum Bag SU Large, a non-sterile specimen container, on March 9, 2026, because there is a possibility of reagent leakage from the container. The product was distributed worldwide, including the US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden. The FDA added the recall to its Enforcement Report on April 24, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Vacuum Bag SU Large, Non-sterile specimen container
- Model number
- 68409SS
- UDI-DI
- 08052478981055
- Lot code
- 2024-09
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
- Company
- Milestone S.R.L.Sorisole, Italy
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98632
- Recall number
- Z-1944-2026
- Quantity recalled
- 61600 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
