{"recall":{"id":"fda-device-99085","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineeri","firm":"BD SWITZERLAND SARL","date":"2026-06-04","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"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":"Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445","quantity":"50 devices","number":"Z-2654-2026","classification":"Class II"}],"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).","affected":"U.S.: IL  O.U.S: N/A","nationwide":false,"states":["IL"],"units":"50 devices","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99085","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f9abd5c1f1c6fc84","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99085","record":[{"status":"Ongoing","city":"Eysins","state":"N/A","country":"Switzerland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99085","recalling_firm":"BD SWITZERLAND SARL","address_1":"Terre Bonne Park A4","address_2":"Route De Crassier 17","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"N/A","distribution_pattern":"U.S.: IL  O.U.S: N/A","recall_number":"Z-2654-2026","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","product_quantity":"50 devices","reason_for_recall":"Due to engineering sample labeled \"Not for Human Use\" being inadvertently shipped it the U.S. market.","recall_initiation_date":"20260604","center_classification_date":"20260702","report_date":"20260708","code_info":"Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445"}]}}