{"recall":{"id":"fda-device-98481","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Masimo Corporation recalls 2 products","firm":"Masimo Corporation","date":"2026-02-20","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"Radius VSM ECG pre-connected Set, REF: 4842, 4695","code":"REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF","quantity":"772","number":"Z-2670-2026","classification":"Class II"},{"name":"Radius VSM Disposable NIBP Cuff, REF: 4825, 4826","code":"REF/UDI-DI/Lot: 4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31, E21JWM, E23FVD; 4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK","quantity":"1,028","number":"Z-2671-2026","classification":"Class II"}],"reason":"Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.","nationwide":true,"states":[],"units":"772; 1,028","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=98481","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"f5db79d0b9b8887c","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=98481","record":[{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98481","recalling_firm":"Masimo Corporation","address_1":"52 Discovery","address_2":"N/A","postal_code":"92618-3105","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.","recall_number":"Z-2670-2026","product_description":"Radius VSM ECG pre-connected Set, REF: 4842, 4695","product_quantity":"772","reason_for_recall":"Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.","recall_initiation_date":"20260220","center_classification_date":"20260702","report_date":"20260708","code_info":"REF/UDI-DI/Lot:  4842/10843997011003/25AJH, 25KMA, 25MSC  4695/10843997016015/24N17, 25BBJ,  25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF"},{"status":"Ongoing","city":"Irvine","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"98481","recalling_firm":"Masimo Corporation","address_1":"52 Discovery","address_2":"N/A","postal_code":"92618-3105","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of OK, CA , MD , MA , NY , UT , NC , TN , MN , TX , OH , PA , VA and the countries of Italy, Latvia, Iraq, Saudi Arabia, Germany, Spain, Turkey, France, Australia, Malta, Oman, United Arab Emirates, Martinique, Netherlands, Cyprus, Kuwait, Czech Republic, United Kingdom, Croatia, Switzerland, Belgium, Singapore, Romania, Colombia, Hong Kong, Israel, Finland, Poland, New Zealand, Tunisia, Chile, Algeria, Canada, Denmark, Palestinian Territory, Qatar, Greece, Paraguay.","recall_number":"Z-2671-2026","product_description":"Radius VSM Disposable NIBP Cuff, REF: 4825, 4826","product_quantity":"1,028","reason_for_recall":"Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.","recall_initiation_date":"20260220","center_classification_date":"20260702","report_date":"20260708","code_info":"REF/UDI-DI/Lot:  4825/00843997006989/21G6S, 22JHV, 23H03, 23J05, 24DBV, 24NGG, 25ADG, E21D31,  E21JWM, E23FVD;  4826/10843997006993/21HVX, 22ELB, 23G31, 23H04, 23HWL, 23J06, 24DBW, 24MNP, 24NGF, 25ADF, E21D32, E21F04, E21JFA, E21KHK"}]}}