Reported Sep 29, 2021 · Terminated

Soft Tissue Biopsy Needles

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?

  • Soft Tissue Biopsy Needles
Lot codes and dates

144 of 144 products

Products covered by this recall
Model / numberProduct as published
MGK11210
Lot Numbers: 5216C
MGK11410
Lot Numbers: 5216C, 1217B, 3620D
MGK11413
Lot Numbers: 5216C
MGK11415
Lot Numbers: 3620D
MGK11610
Lot Numbers: 5216C, 3620D
MGK11615
Lot Numbers: 3620D
MGK11616
Lot Numbers: 5216C, 1217B
MGK11620
Lot Numbers: 1617A
MGK11810
Lot Numbers: 5216C
MGK11816
Lot Numbers: 5216C
Amount recalled
20,129 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.

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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, 6:20 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.