{"recall":{"id":"fda-device-99285","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Terumo Medical Corporation recalls GLIDESHEATH SLENDER A-KIT 6F 10CM ","firm":"Terumo Medical Corporation","date":"2026-06-15","reported":"2026-08-19","status":"Ongoing","classification":"Class II","products":[{"name":"GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.","code":"Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.","quantity":"7,490 units","number":"Z-2930-2026","classification":"Class II"}],"reason":"Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"7,490 units","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=99285","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ce8f86137f04215f","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=99285","record":[{"status":"Ongoing","city":"Elkton","state":"MD","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99285","recalling_firm":"Terumo Medical Corporation","address_1":"950 Elkton Blvd","address_2":"","postal_code":"21921-5322","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-2930-2026","product_description":"GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060.    The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.","product_quantity":"7,490 units","reason_for_recall":"Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.","recall_initiation_date":"20260615","center_classification_date":"20260810","report_date":"20260819","code_info":"Product Code: 60-1060. Shelfbox UDI-DI: 30389701011975; Pouch UDI-DI: 00389701011974; UDI-PI: (17)280501(10)0001441871. Lot Number: 0001441871.","more_code_info":""}]}}