Z-1944-2026Class II

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS

Name: Z-1944-2026 VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Creator: Milestone S.R.L.
Published: 2026-03-09
License: https://open.fda.gov/license/

Milestone S.p.A. / initiated 2026-03-09 / Open, Classified

FDA source

Milestone S.R.L. began a recall of VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS on 2026-03-09. FDA classified it as Class II and gives the reason as "There is a possibility of reagent leakage from the specimen container". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1944-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-09
Posted: 2026-04-24
Recalling firm: Milestone S.p.A.
Product: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Product code: NNI Container, Specimen, Non-Sterile
Reason for recall: There is a possibility of reagent leakage from the specimen container.
FDA 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: [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 08052478981055; Lot Number: 2024-09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-24

Product code NNI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)