Z-2491-2021Class II

Mammary Nodules Localization

Name: Z-2491-2021 Mammary Nodules Localization
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 Mammary Nodules Localization 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-2491-2021
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: Mammary Nodules Localization
Product code: GDF Guide, Needle, Surgical
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: 320 units
Distribution: Nationwide
Product codes and lots: Model Number PN2010, Lots: 3620D Model Number PN2012, Lots: 1317 Model Number PN2015, Lots: 3620D Model Number PNA2005, Lots: 5216C Model Number PNA2010, Lots: 3620D Model Number PNA2015, Lots: 3620D Model Number PNAX2005, Lots: 5216C Model Number PNS2010, Lots: 3620D Model Number PNS2015, Lots: 3620D Model Number PNX2010, Lots: 0817A Model Number PR2005, Lots: 5216C, 4920B Model Number PR2007, Lots: 5216C Model Number PR2010, Lots: 3620D Model Number PR2015, Lots: 3620D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2491-2021
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 GDF

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)