Reported Jun 28, 2023 · Ongoing

Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503

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
  • REF2503
Lot codes and dates
  • UDI-DI
    • (01)00843997003230 Lot #: 13HBT
    • 15DAV
    • 17FAN
    • 17HAX
    • 17J12
    • 17MDF
    • 17N09
    • 18A28
    • 18AVB
    • 18CUV
    • 18FQZ
    • 18J33
    • 18K48
    • 18KSS
    • 18MBC
    • 19ALF
    • 19CAY
    • 19D84
    • 19HMB
    • 19N1C
    • 20CRT
    • 20FMM
    • 20KWK
    • 21CRG
    • 21EMP
    • 21FFY
    • 21FWV
    • 21G2K
    • 21GTL
    • 21HWG
    • 21KGD
    • 21MEF
    • 22AVS
    • 22BSC
    • 22DGZ
    • 22DUG
    • 22ESP
    • 22GDZ
    • 22J4J
    • 22K64
    • 22NYC
    • 23AAE
    • E21DXT
    • K16HCA
    • K16JFC
    • K17BCR
Amount recalled
123,745 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, 6:17 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.