Reported Sep 29, 2021 · Terminated

Mammary Nodules Localization

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: M.D.L. S.r.l. · Via Tavani N. 1/A · Delebio · N/A

Is this the product you have?

  • Mammary Nodules Localization
Lot codes and dates
  • Model Number PN2010
  • Lots3620D Model Number PN2012
  • Lots1317 Model Number PN2015
  • Lots3620D Model Number PNA2005
  • Lots5216C Model Number PNA2010
  • Lots3620D Model Number PNA2015
  • Lots3620D Model Number PNAX2005
  • Lots5216C Model Number PNS2010
  • Lots3620D Model Number PNS2015
  • Lots3620D Model Number PNX2010
  • Lots0817A Model Number PR2005
  • Lots
    • 5216C
    • 4920B Model Number PR2007
  • Lots5216C Model Number PR2010
  • Lots3620D Model Number PR2015
  • Lots3620D
Amount recalled
320 units

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

Why it was recalled

Sterility assurance may be compromised.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 4, 2026 · Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.