FDA Medical Device Recalls (openFDA)
M.D.L. S.r.l.: Aspirated Cyto-Histological Biopsy needle
- Recall number
- Z-2490-2021
- Recalling firm
- M.D.L. S.r.l.
- Product
- Aspirated Cyto-Histological 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
- 2750 devices
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- 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