Radius VSM Disposable NIBP Cuff — Class II medical device recall Z-2671-2026
Ongoing recall by Masimo Corporation, reported 2026-07-08, distributed nationwide. Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme
| Recall number | Z-2671-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Masimo Corporation, Irvine, CA, United States |
| Recall initiated | 2026-02-20 |
| Classified | 2026-07-02 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CL, CO, CY, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HK, HR, IL, IQ, IT, KW, LV, MT, NL, NZ, OM, PL, PY, QA, RO, SA, SG, TN, TR |
| Quantity | 1,028 |
| UPC / GTIN / UDI-DI | 00843997006989, 10843997006993 |
| Lot numbers | 22ELB, 22JHV, 23G31, 23H03, 23H04, 23HWL, 23J05, 23J06, 24DBV, 24DBW, 24MNP, 24NGF, 24NGG, 25ADF, 25ADG, 4825/00843997006989/21G6S, 4826/10843997006993/21HVX, E21D31, E21D32, E21F04, E21JFA, E21JWM, E21KHK, E23FVD |
| Model numbers | 4825, 4826 |
Product
Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2671-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.