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U.S. Department of Health and Human Services

Class 2 Device Recall VACUUM BAG SU LARGE

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 Class 2 Device Recall VACUUM BAG SU LARGEsee related information
Date Initiated by FirmMarch 09, 2026
Date PostedApril 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1944-2026
Recall Event ID 98632
Product Classification Container, specimen, non-sterile - Product Code NNI
ProductVACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Code Information UDI-DI: 08052478981055; Lot Number: 2024-09
FEI Number 1000391282
Recalling Firm/
Manufacturer		 Milestone S.R.L.
Via Fatebenefratelli 1/5
Sorisole Italy
Manufacturer Reason
for Recall		There is a possibility of reagent leakage from the specimen container.
FDA Determined
Cause 2		Under Investigation by firm
ActionA 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: regulatory@milestonesrl.com
Quantity in Commerce61600 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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