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

General Manual surgical instrument recalled by M.D.L. S.r.l

M.D.L. S.r.l is recalling General Manual surgical instrument, 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 MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A

Quantity recalled4120 units

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-2493-2021
FDA event ID: 88430
Recalling firm: M.D.L. S.r.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: Surgical Instruments

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

General Manual surgical instrument

Where it was distributed

Nationwide

Questions about this recall

Is General Manual surgical instrument recalled?

Yes. M.D.L. S.r.l recalled General Manual surgical instrument on 5 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-2493-2021.

Why was it recalled?

Sterility assurance may be compromised.

Which lots are affected?

Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A

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

More recalls from M.D.L. S.r.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. S.r.l	Sterility	Nationwide
29 Sep 2021Device	CLASS II	Aspirated Cyto-Histological Biopsy needle recalled by M.D.L. S.r.l	M.D.L. S.r.l	Sterility	Nationwide
29 Sep 2021Device	CLASS II	Mammary Nodules Localization recalled by M.D.L. S.r.l	M.D.L. S.r.l	Sterility	Nationwide
29 Sep 2021Device	CLASS II	Soft Tissue Biopsy Needles recalled by M.D.L. S.r.l	M.D.L. S.r.l	Sterility	Nationwide

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