CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report

Aspirated Cyto-Histological Biopsy needle recalled by M.D.L. S.r.l

M.D.L is recalling Aspirated Cyto-Histological Biopsy needle, distributed nationwide in the US. The recall was initiated on 5 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A

Quantity recalled2750 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2490-2021
FDA event ID: 88430
Recalling firm: M.D.L, Delebio
Classification: Class II
Status: Terminated
Recall initiated: 5 Aug 2021
FDA classified: 20 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Syringes & Needles

Timeline

5 Aug 2021	Recall initiated by company
20 Sep 2021	Classified by FDA	+46 days
29 Sep 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Sterility assurance may be compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Aspirated Cyto-Histological Biopsy needle

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Sterility assurance may be compromised.

Which lots are affected?

Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 88430

This product is part of a recall event; the main page for the event is Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l.

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021	CLASS II	Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021	CLASS II	Mammary Nodules Localization recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021	CLASS II	General Manual surgical instrument recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021	CLASS II	Bone Marrow Transplantation biopsy needle recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide

More recalls from M.D.L

All 5

Reported	Class	Recall	Company	Reason	Where
29 Sep 2021Device	CLASS II	Bone Marrow Transplantation biopsy needle recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021Device	CLASS II	General Manual surgical instrument recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021Device	CLASS II	Mammary Nodules Localization recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide
29 Sep 2021Device	CLASS II	Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l	M.D.L	Sterility	Nationwide

Other Syringes & Needles recalls

All 1,060

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS I	BD Needle Kit for Powered Driver recalled by Bard Access Systems	Bard Access Systems	Other	32 states
19 Aug 2026Device	CLASS II	Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled	Galt Medical	Other	Nationwide
15 Jul 2026Device	CLASS II	Geneva Brachytherapy Applicator recalled by Elekta	Elekta	Other	Nationwide
15 Jul 2026Device	CLASS II	Brachytherapy Applicator Advanced Gynecological Applicator recalled	Elekta	Other	Nationwide
8 Jul 2026Device	CLASS II	Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled	BD Switzerland Sarl	Other	IL