HIGHFDA DEVICE

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

There is a possibility of reagent leakage from the specimen container.

Milestone S.R.L.Health & Personal CareMedical DevicesUDI-DI: 08052478981055Lot Number: 2024-09

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 9, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 9, 2026
Hazard Level
HIGH
Brand
Milestone S.R.L.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Milestone S.R.L.
Model numbers
UDI-DI: 08052478981055, Lot Number: 2024-09
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 9, 2026

  2. Reported by FDA DEVICE

    May 6, 2026

  3. RecallRadar source check

    May 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

There is a possibility of reagent leakage from the specimen container.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Milestone S.R.L. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS. Reason: There is a possibility of reagent leakage from the specimen container.. Classification: Class II. 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 08052478981055
Lot Number: 2024-09
Affected States
ALL
Report Date
May 6, 2026
Recall Status
ACTIVE