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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Milestone VACUUM BAG SU LARGE Specimen Containers Recalled for Reagent Leakage

Agency Publication Date: April 24, 2026
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Summary

Milestone S.R.L. has recalled approximately 61,600 VACUUM BAG SU LARGE non-sterile specimen containers because they may leak chemical reagents. These containers, model number 68409SS, were distributed worldwide to medical facilities and laboratories. No injuries or incidents have been reported to date, but the defect could lead to exposure to laboratory chemicals or the loss of important diagnostic specimens.

Risk

The specimen containers may leak chemical reagents used for preserving medical samples. This poses a risk of chemical exposure to laboratory staff and can compromise the integrity of the medical specimen being transported or stored.

What You Should Do

  1. Identify your product by checking for Model/Catalog Number 68409SS and Lot Number 2024-09 on the packaging or device label.
  2. Check for the Unique Device Identifier (UDI-DI) 08052478981055 printed on the product barcode.
  3. Stop using the recalled product immediately.
  4. Contact the manufacturer, Milestone S.R.L., or your authorized medical distributor to arrange for the return, replacement, or correction of the affected containers.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VACUUM BAG SU LARGE, Non-sterile specimen container
Model / REF:
68409SS
Lot Numbers:
2024-09
UDI:
08052478981055

Lot Number: 2024-09

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98632
Status: Active
Manufacturer: Milestone S.R.L.
Sold By: authorized medical distributors
Manufactured In: Italy
Units Affected: 61,600
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.