Reported Sep 29, 2021 · Terminated

Aspirated Cyto-Histological Biopsy needle

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?

  • Aspirated Cyto-Histological Biopsy needle
Lot codes and dates

14 of 14 products

Products covered by this recall
Model / numberProduct as published
PB1810
PB1815Lot 1617A
PB1820Lots 5216C and 3620D
PB1825Lot 5216C
PB2010Lot 5216C
PB2015Lot 1617A
PB2020Lots 5216C, 2618B, and 3620D
PB2110Lots 5216C and 1618A
PB2115Lot 5216C
PB2120Lot 5216C
PB2215Lot 1617A
PB2220Lot 5216C
PB2225Lots 5216C, 1618A, 3620D
Lot 2518A
Amount recalled
2750 devices

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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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, 6:21 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.