RegWardenFDA facility compliance records
Recall

Class II — M.D.L. S.r.l.

Recalling firmM.D.L. S.r.l.
Registered facilityM.D.L. S.R.L. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSterility assurance may be compromised.
ProductBone Marrow Transplantation biopsy needle
Quantity21,518 units
DistributionNationwide
Initiated2021-08-05
Classified2021-09-20
Terminated2026-05-04
Recall numberZ-2489-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — M.D.L. S.r.l. (Z-2489-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88430/

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