{"recall":{"id":"fda-device-99728","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"DeRoyal Industries Inc recalls REF: 81-030415 Myocardial Probe Non-Pyrogenic ","firm":"DeRoyal Industries Inc","date":"2026-08-20","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series","code":"DI: 00749756046077/Lot # 63426754","quantity":"7 cases, 140 units","number":"Z-3256-2026","classification":"Class II"}],"reason":"Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of LA,MO, MD, TN, UT.","nationwide":true,"states":[],"units":"7 cases, 140 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=99728","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a6a1f8e136783b5b","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=99728","record":[{"status":"Ongoing","city":"Powell","state":"TN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99728","recalling_firm":"DeRoyal Industries Inc","address_1":"200 Debusk Ln","address_2":"","postal_code":"37849-4703","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of LA,MO, MD, TN, UT.","recall_number":"Z-3256-2026","product_description":"REF: 81-030415  Myocardial Probe Non-Pyrogenic , 400 Series","product_quantity":"7 cases, 140 units","reason_for_recall":"Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.","recall_initiation_date":"20260820","center_classification_date":"20260922","report_date":"20260930","code_info":"DI: 00749756046077/Lot # 63426754","more_code_info":""}]}}