FDA recall Z-2654-2026

BD SWITZERLAND SARL · Class II · device

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

Reason for recall

Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

Distribution

U.S.: IL O.U.S: N/A

Key facts

Status
Ongoing
Initiation date
2026-06-04
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eysins, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2654-2026