CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
SU Large, Non-sterile specimen container recalled by Milestone S.R.L
Milestone is recalling SU Large, Non-sterile specimen container, distributed nationwide in the US. The recall was initiated on 9 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1944-2026
- FDA event ID
- 98632
- Recalling firm
- Milestone, Sorisole
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Mar 2026
- FDA classified
- 24 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Mar 2026 | Recall initiated by company | |
| 24 Apr 2026 | Classified by FDA | +46 days |
| 6 May 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a possibility of reagent leakage from the specimen container.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Questions about this recall
Why was it recalled?
There is a possibility of reagent leakage from the specimen container.
Which lots are affected?
UDI-DI: 08052478981055; Lot Number: 2024-09
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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