Z-2489-2021Class II

Bone Marrow Transplantation biopsy needle

Name: Z-2489-2021 Bone Marrow Transplantation 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 Bone Marrow Transplantation 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-2489-2021
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: Bone Marrow Transplantation biopsy needle
Product code: DWO Needle, Biopsy, Cardiovascular
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: 21,518 units
Distribution: Nationwide
Product codes and lots: Model PI1535/100, Lot Numbers: 3620D Model PIL1410/75, Lot Numbers: 1617A Model PIL1435/100, Lot Numbers: 1617A Model PIL1510/75, Lot Numbers: 3620D, 3620E Model PIL1535/100, Lot Numbers: 5216C, 3620D Model PIL1610/75, Lot Numbers: 3620D, 3620E, 4120 Model PIL1635/100, Lot Numbers: 5216C Model PIL1835/100, Lot Numbers: 5216C Model PIP1410/50, Lot Numbers: 1617A Model PIP1430/70, Lot Numbers: 1617A Model PIP1510/50, Lot Numbers: 1217B, 1618A Model PIP1530/70, Lot Numbers: 1617A Model PIP1630/70, Lot Numbers: 1617A Model PIP1810/50, Lot Numbers: 0818, 1618A Model PIP1830/70, Lot Numbers: 1617A Model PJ0810, Lot Numbers: 3620D Model PJ1110, Lot Numbers: 3620D, 4920B Model PJ1306, Lot Numbers: 3620D Model PJE1110, Lot Numbers: 5216, 5216C, 1417A, 3517C, 4617, 0818, 1418, 2518A, 4018, 4318D, 5018, 1119B, 1119C, 1119A, 3620D Model PJK21110, Lot Numbers: 3616C, 3620D Model PJK21115, Lot Numbers: 3416C Model PJK21310, Lot Numbers: 3416C, 3620D Model PJT0810, Lot Numbers: 4220B, 4320D, 4320D Model PJT0815, Lot Numbers: 4220D, 4320E Model PJT1110, Lot Numbers: 1417A, 3620D, 3620D, 3620D, 4220B, 4220B, 4220B, 4220A, 4320F, 4320D Model PJT1115, Lot Numbers: 3620D, 4220B, 4320D Model PJT1306, Lot Numbers: 1417A, 3517C, 3620D, 3620E, 4220B, 4320D Model PJT1310, Lot Numbers: 3620D, 4220B, 4420A, 4320D Model PS0810, Lot Numbers: 2518A, 1119A Model PS1110, Lot Numbers: 4316, 4316A, 4316B, 4316B, 2618, 4018, 3620D Model PS1115, Lot Numbers: 3620D Model PS1306, Lot Numbers: 3620D Model PS1310, Lot Numbers: 3916, 3620D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2489-2021
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 DWO

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)