Recall StatusOpen, Classified
Date Initiated2026-03-09
Product Quantity61600 units
Reason for Recall
There is a possibility of reagent leakage from the specimen container.
Firm Action
A RECALL Field Safety Note (FSN) Field Safety Corrective Action (FSCA) dated 3/9/26 was sent to customers.
Advice on immediate action to take
Contact immediately your distributor.
If the LOT/BATCH number reported on the box is the same as the reported above:
1. do not use, neither distribute, REF 68409SS VACUUM BAG SU LARGE;
2. contact immediately your distributor, or Milestone S.P.A..
We warn you to dispose of the unused container present in your stock and not used yet.
Milestone will replace them with new ones.
Transmit of this Field Safety Notice:
This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred.
Please transfer this notice to other organizations on which this action has an impact.
Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Please report all device-related incidents to Milestone S.P.A. (at the e-mail address reported below), distributor or local representative, and the national Competent Authority if appropriate, as this provides important feedback.
If you have further questions, do not hesitate to contact us:
[email protected]
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.