{"url_path":"/fda/device/recalls/Z-2654-2026","section_key":"summary","section_title":"DEVICE Recall: 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","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-04","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2654-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"BD SWITZERLAND SARL"},"word_count":85,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2654-2026\n\n**Recalling firm:** BD SWITZERLAND SARL\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-04\n**Report date:** 2026-07-08\n\n## Product\nMEDLINE 111  GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555  Catalog Number: SAM2461  UDI code: N/A    Engineering Sample/Not for Human Use\n\n## Reason\nDue to engineering sample labeled \"Not for Human Use\" being inadvertently shipped it the U.S. market.\n\n## Affected lots\nCatalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445\n\n## Distribution\nU.S.: IL  O.U.S: N/A"}