Reported Jun 28, 2023 · Ongoing

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895

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 LNCS TC-I SpO2, Reusable Ear Sensor
  • REF1895
Lot codes and dates
  • UDI-DI

    205 of 205 codes

    • (01)00843997000048 Lot #: 13NBR
    • 13NBS
    • 14B96
    • 14CWW
    • 14GFV
    • 14JFW
    • 14KYQ
    • 14N03
    • 15C01
    • 15EBB
    • 15HNT
    • 17DCG
    • 17DCH
    • 17DCJ
    • 17DYJ
    • 17DYK
    • 17E83
    • 17E84
    • 17FAL
    • 17FAM
    • 17GER
    • 17GNT
    • 17HAV
    • 17HLA
    • 17HLB
    • 17HZD
    • 17J08
    • 17J09
    • 17JRE
    • 17KBQ
    • 17KBR
    • 17MDD
    • 17MDE
    • 17MPD
    • 17N06
    • 17N07
    • 17NFD
    • 18A26
    • 18A27
    • 18B99
    • 18BAA
    • 18CCT
    • 18CWV
    • 18CYG
    • 18DCB
    • 18EEC
    • 18ENJ
    • 18FAG
    • 18G1V
    • 18GND
    • 18GUC
    • 18H3N
    • 18HVP
    • 18J32
    • 18JPJ
    • 18JVL
    • 18K47
    • 18K52
    • 18M01
    • 18M02
Amount recalled
443,799 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, 4:51 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.