M.D.L. S.r.l.: Medical Device Recall in 2021 - (Recall #: Z-2490-2021)

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:

Aspirated Cyto-Histological Biopsy needle

Product Classification:

Class II

Date Initiated: August 5, 2021

Date Posted: September 29, 2021

Recall Number: Z-2490-2021

Event ID: 88430

Reason for Recall:

Sterility assurance may be compromised.

Status: Ongoing

Product Quantity: 2750 devices

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated