Reported Jun 28, 2023 · Ongoing

Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794

Masimo Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Masimo Corporation · 52 Discovery · Irvine, CA · 92618-3105

Is this the product you have?

  • Masimo LNOP TC-I SpO2, Reusable Ear Sensor
  • REF1794
Lot codes and dates
  • UDI-DI
    • (01)00843997000239 Lot #: K16ANC
    • K16MWR
    • K17AEU
    • 17EGQ
Amount recalled
86 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

TC-I tip clip sensor may produce readings outside the accuracy specification.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.