Recall Record

Sorisole, Italy

Milestone S.R.L. recalls

1 recall recorded since 2018, most recently on 9 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
9 March 2026
Reason
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.
Initiated
Voluntary: Firm initiated
Recall number
Z-1944-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.