Z-2493-2021Class II

General Manual surgical instrument

Name: Z-2493-2021 General Manual surgical instrument
Creator: M.D.L. S.r.l.
Published: 2021-08-05
License: https://open.fda.gov/license/

M.D.L. S.r.l. / initiated 2021-08-05 / Terminated / root cause: sterility

FDA source

M.D.L. S.r.l. began a recall of General Manual surgical instrument on 2021-08-05. FDA classified it as Class II and gives the reason as "Sterility assurance may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2493-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-05
Posted: 2021-09-20
Terminated: 2026-05-04
Recalling firm: M.D.L. S.r.l.
Product: General Manual surgical instrument
Product code: MJG Device, Percutaneous, Biopsy
Reason for recall: Sterility assurance may be compromised.
Root cause tag: sterility
FDA root cause: Other
Action: The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers.
Quantity in commerce: 4120 units
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2493-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2489-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2490-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2491-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2492-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20
Z-2493-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-20

Product code MJG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)