MasimoSET LNCS® TC-I SpO2 Reusable Ear Sensor 1895Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997000048), received between Feb 5, 2019 and Nov 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Readings” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K051212); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 21, 2023Class IIOpen, Classified

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

   Z-1985-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025High Readings; High Readings

  THE CUSTOMER REPORTED "A PATIENT HOSPITALIZED FOR TYPE 2 RESPIRATORY FAILURE AND VENTILATED WITH NIV PRESENTED A MARKED DISCREPANCY BETWEEN THE MEASURED SATURATION VALUES(SPO2 89¿91%) AND THE RESULTS OF SEVERAL SUCCESSIVE BLOOD GAS ANALYSES, INDICATING SEVERE HYPOXEMIA. CLINICAL CHECKS SHOWED NO DETERIORATION, AND THE SPO2 SIGNAL APPEARED TO BE OF ADEQUATE QUALITY (PERFUSION INDEX 1.25). PER THE REPORTED INFORMATION, THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS NOR SERIOUS CONSEQUENCES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23550494 ↗
• MalfunctionMar 4, 2023Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THE SENSOR "SHOWS VALUES THAT SEEM CORRECT, AND THE NEXT TIME YOU GET DIFFERENT VALUES." NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483290 ↗
• MalfunctionFeb 5, 2019Low Readings; Low Readings

  THE CUSTOMER REPORTED THE DEVICE PROVIDED INACCURATE SPO2 VALUES. THE EXPECTED VALUE WAS 94 AND THE MONITOR SHOWED 74. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8308621 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051212. One submission often covers many models, so check the product and lot details in each record.

• Z-1986-2023 · Apr 21, 2023 · Open, Classified
  Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
• Z-2640-2017 · Apr 4, 2016 · Terminated
  SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human pa
• Z-2642-2017 · Apr 4, 2016 · Terminated
  MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures,
• Z-2641-2017 · Apr 4, 2016 · Terminated
  Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient und