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Z-2654-2026Class II

BD SWITZERLAND SARL

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
BD SWITZERLAND SARL
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
U.S.: IL O.U.S: N/A
Firm state
N/A
Product quantity
50 devices
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →