FDA Medical Device Recalls (openFDA)
Milestone S.R.L.: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
- Recall number
- Z-1944-2026
- Recalling firm
- Milestone S.R.L.
- Product
- VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
- Status
- Open, Classified
- Initiated
- 2026-03-09
- Posted
- 2026-04-24
- Terminated
- not on file
- Reason
- There is a possibility of reagent leakage from the specimen container.
- Root cause
- Under Investigation by 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: regulatory@milestonesrl.com
- Quantity
- 61600 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
- Lot, serial or model codes
- UDI-DI: 08052478981055; Lot Number: 2024-09
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NNI
- Firm FEI
- 1000391282
- Firm city
- Sorisole
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28