Radius VSM Disposable NIBP Cuff: recall status

Notice names this product. Masimo’s Radius VSM Disposable NIBP Cuff is named in FDA Class II recall Z-2671-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: 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. Units affected: 1,028. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Radius VSM Disposable NIBP Cuff
Company / brand: Masimo
Lot / serial / date codes: 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
Distribution: 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.

Agency product description and boundaries

Radius VSM Disposable NIBP Cuff, REF: 4825, 4826

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Masimo

Recalls naming this model

FDA Class II · Medical device · July 8, 2026

Radius VSM Disposable NIBP Cuff recall — Masimo Corporation

Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate pati…

Company / brand: Masimo recalls

Affected product: Radius VSM Disposable NIBP Cuff recall status

Official ID Z-2671-2026 · Official record ↗

See all Masimo recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.