FDAClass IISeptember 29, 2021

Aspirated Cyto-Histological Biopsy needle recall: Sterility Concern

Aspirated Cyto-Histological Biopsy needle

Why was Aspirated Cyto-Histological Biopsy needle recalled?

Sterility assurance may be compromised.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Aspirated Cyto-Histological Biopsy needle
Recalling firm
M.D.L. S.r.l.
Quantity
2750 devices
Distribution
Nationwide
Recall date
September 29, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls