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Class IIOngoing

BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineeri

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
BD SWITZERLAND SARL
Reason
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
U.S.: IL O.U.S: N/A
Where
Illinois
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99085…

Products

  1. 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

    Codes/lots: Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445Quantity: 50 devicesRecall no. Z-2654-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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