Home / Recalls / Masimo Corporation / Z-2670-2026

Z-2670-2026 Class II Ongoing

Recalled by Masimo Corporation — Irvine, CA

FDA device recall Z-2670-2026 was initiated by Masimo Corporation on February 20, 2026 and is designated Class II. 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 dist… The recall status is ongoing. Affected quantity: 772.

Recall Details

Product Type: Devices
Report Date: July 8, 2026
Initiation Date: February 20, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 772

Product Description

Radius VSM ECG pre-connected Set, REF: 4842, 4695

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.

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.

Code Information

REF/UDI-DI/Lot: 4842/10843997011003/25AJH, 25KMA, 25MSC 4695/10843997016015/24N17, 25BBJ, 25DMH, 25FBR, 24KLV, 24N17, 25AGZ, 25BBJ, 25D10, 25DMH, 25FBR, 25GJM, 25KBF

Other recalls by Masimo Corporation

Z-2671-2026 Class II — Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 (February 20, 2026)
Z-1539-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, (February 15, 2024)
Z-1538-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, (February 15, 2024)
Z-1537-2024 Class II — Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, (February 15, 2024)
Z-1536-2024 Class II — Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, (February 15, 2024)
Z-1984-2023 Class II — Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 (April 21, 2023)
Z-1985-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 (April 21, 2023)
Z-1983-2023 Class II — Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 (April 21, 2023)
Z-1986-2023 Class II — Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 (April 21, 2023)
Z-0338-2016 Class II — rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAI (October 28, 2015)