RecallRadar

FDA Device recall Z-2490-2021

Aspirated Cyto-Histological Biopsy needle

On 2021-09-29 the FDA classified a Class II recall of Aspirated Cyto-Histological Biopsy needle by M D L S R L, citing sterility assurance may be compromised.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2490-2021
ClassificationClass II
Statusterminated
Initiated2021-08-05
Published2021-09-29
Last updated2026-09-13 11:56 UTC
CompanyM D L S R L
DistributionUS

Product

Aspirated Cyto-Histological Biopsy needle

Reason

Sterility assurance may be compromised.

Identifiers

code_info
Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB…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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2490-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.