FDA Medical Device Recalls (openFDA)
BIOPSYBELL S.R.L.: 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
- Recall number
- Z-1643-2021
- Recalling firm
- BIOPSYBELL S.R.L.
- Product
- 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD
- Status
- Terminated
- Initiated
- 2021-03-22
- Posted
- 2021-05-19
- Terminated
- 2026-02-17
- Reason
- Products labeled as sterile were distributed, but may not have been sterilized.
- Root cause
- Vendor change control
- Action
- The firm notified two consignees with the preliminary information by email on 03/22/2021 and followed with the official notice with the complete information on 04/08/2021 to all consignees. The letter requested that the consignee cease using the affected product and contact Biopsybell or a Biopsybell representative for product return/disposal and related replacement. Distributors were directed to identify those who received the product and notify them.
- Quantity
- 75 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Lot, serial or model codes
- LOT: 2002437
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LOD
- Firm FEI
- 3003272754
- Firm city
- Mirandola
- 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