FDA Medical Device Recalls (openFDA)
M.D.L. S.r.l.: Bone Marrow Transplantation biopsy needle
- Recall number
- Z-2489-2021
- Recalling firm
- M.D.L. S.r.l.
- Product
- Bone Marrow Transplantation biopsy needle
- Status
- Terminated
- Initiated
- 2021-08-05
- Posted
- not on file
- Terminated
- 2026-05-04
- Reason
- Sterility assurance may be compromised.
- 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
- 21,518 units
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWO
- Firm FEI
- 3004749705
- Firm city
- Delebio
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28