The Recall Desk
HighFDA (Devices)·Z-1986-2023·Announced 2023-06-28

Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a technical accuracy failure in a clinical monitoring device, which qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Masimo Corporation is recalling 123,745 units of the LNCS TC-I SpO2 reusable ear sensor (REF: 2503). The TC-I tip clip sensor may produce readings that fall outside the manufacturer's stated accuracy specification.

This sensor is used in clinical settings to measure patients' blood oxygen saturation levels. If readings are outside the accuracy specification, they may not reliably represent a patient's actual oxygen saturation.

The affected devices were distributed throughout all 50 US states and 48 additional countries, including Canada, Australia, Japan, and multiple European nations. Specific affected lot numbers are identified in the FDA recall database.

Healthcare facilities using this sensor model should verify their device lot numbers and contact Masimo for information about replacement, repair, or device return.

The recalled product

Product
Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
Manufacturer
Masimo Corporation
Category
Medical Device — Pulse Oximetry / Ear Sensor
Hazard
Affected units
123,745

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed in 51 states:

Part of a larger recall action

This product is one of 4 recalled by Masimo Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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