{"recall":{"id":"fda-device-99901","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Merit Medical Systems, Inc. recalls Scout MD","firm":"Merit Medical Systems, Inc.","date":"2026-08-27","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO","code":"MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911","quantity":"","number":"Z-0187-2027","classification":"Class II"}],"reason":"The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US: AZ, CA, FL, IN, LA,  NV, RI OUS: None","nationwide":false,"states":["AZ","CA","FL","IN","LA","NV","RI"],"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=99901","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8dfe876866918c84","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=99901","record":[{"status":"Ongoing","city":"South Jordan","state":"UT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99901","recalling_firm":"Merit Medical Systems, Inc.","address_1":"1600 W Merit Pkwy","address_2":"","postal_code":"84095-2416","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US: AZ, CA, FL, IN, LA,  NV, RI OUS: None","recall_number":"Z-0187-2027","product_description":"Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01   Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO","product_quantity":"","reason_for_recall":"The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use.","recall_initiation_date":"20260827","center_classification_date":"20261015","report_date":"20261021","code_info":"MDS05A-01-Lot: H3515477/UDI:00884450392850; MDS05C-01 - Lot: H3507786/UDI:00884450392874; MDS10C-01 - Lot:H3507794/UDI:00884450392911","more_code_info":""}]}}