Z-2490-2021Class II

Aspirated Cyto-Histological Biopsy needle

Name: Z-2490-2021 Aspirated Cyto-Histological Biopsy needle
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 Aspirated Cyto-Histological Biopsy needle 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-2490-2021
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: Aspirated Cyto-Histological Biopsy needle
Product code: GAA Needle, Aspiration And Injection, Disposable
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: 2750 devices
Distribution: Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2490-2021
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 GAA

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)