{"url_path":"/fda/device/recalls/Z-2671-2026","section_key":"summary","section_title":"DEVICE Recall: Masimo Corporation — Radius VSM Disposable NIBP Cuff, REF: 4825, 4826","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-02-20","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2671-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Masimo Corporation"},"word_count":204,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2671-2026\n\n**Recalling firm:** Masimo Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-02-20\n**Report date:** 2026-07-08\n\n## Product\nRadius VSM Disposable NIBP Cuff, REF: 4825, 4826\n\n## Reason\nTwo 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.\n\n## Affected lots\nREF/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\n\n## Distribution\nWorldwide - 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."}