VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Summary
The FDA issued a Class II for VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409 by Milestone S.R.L.. Reason: There is a possibility of reagent leakage from the specimen container..
Details
Source
Device Recall
External ID
Z-1944-2026
Action Date
2026-05-06
Status
Ongoing
Category
device
Product Description
VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
Lot/Code Info: UDI-DI: 08052478981055; Lot Number: 2024-09
Quantity Affected: 61600 units
Reason for Recall
There is a possibility of reagent leakage from the specimen container.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Israel, UK, Belgium, Spain, France, Greece, Italy, Luxembourg, The Netherlands, Portugal, and Sweden.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-09
Company
Sorisole
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 275 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Milestone S.R.L.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Milestone S.R.L. have FDA actions?
This is the only FDA action we have on record for Milestone S.R.L. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1944-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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