FDA Medical Device Recalls (openFDA)
BD SWITZERLAND SARL: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
- Recall number
- Z-2654-2026
- Recalling firm
- BD SWITZERLAND SARL
- Product
- MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
- Status
- Open, Classified
- Initiated
- 2026-06-04
- Posted
- 2026-07-02
- Terminated
- not on file
- Reason
- Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
- Root cause
- Under Investigation by firm
- Action
- On 06/04/2026, the firm email an "URGENT: MEDICAL DEVICE CORRECTION" Letter informing customers that BD is recalling Engineering Samples labelled Not for Human Use listed above that were inadvertently shipped to the U.S. market. Customers are instructed to: 1. Cease use and destroy any unused affected product listed in the table above according to your facilities regulations. 2. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. For Questions - Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
- Quantity
- 50 devices
- Distribution
- U.S.: IL O.U.S: N/A
- Lot, serial or model codes
- Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3012798826
- Firm city
- Eysins
- Firm state
- not on file
- Firm country
- Switzerland
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