Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mammary Nodules Localization Recalled by M.D.L. S.r.l. Due to Sterility assurance may be compromised.

Date: August 5, 2021
Company: M.D.L. S.r.l.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact M.D.L. S.r.l. directly.

Affected Products

Mammary Nodules Localization

Quantity: 320 units

Why Was This Recalled?

Sterility assurance may be compromised.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About M.D.L. S.r.l.

M.D.L. S.r.l. has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report