Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

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

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Compare the complete identifiers. Name similarity alone is not a confirmed match.

Affected variants from the official event record
Product or model	Codes and lots	Quantity	Recall number
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	Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445	50 devices	Z-2654-2026

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

The linked agency record controls if any information differs.

Official scope

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

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.