M.D.L. S.r.l.: Medical Device Recall in 2021 - (Recall #: Z-2491-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Mammary Nodules Localization

Product Classification:

Class II

Date Initiated: August 5, 2021

Date Posted: September 29, 2021

Recall Number: Z-2491-2021

Event ID: 88430

Reason for Recall:

Sterility assurance may be compromised.

Status: Ongoing

Product Quantity: 320 units

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated