Nellcor D25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884522000844), received between Jun 18, 2024 and Jun 18, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K993637); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SENSOR CAUSED A LOW TEMPERATURE BURN ON THE FOREHEAD OF THE PATIENT WHERE IT WAS APPLIED. THE PATIENT'S SKIN WAS DRY AND PARTIALLY PEELED DUE TO THE INFLUENCE OF THE ANTICANCER DRUG. THE SENSOR WAS USED FOR TWO OR THREE DAYS IN A ROW AND WAS NOT REPLACED. AFTER A DAY OR TWO, REDNESS APPEARED, A FEELING OF HEAT WAS CONFIRMED, AND INFECTION WAS SUSPECTED. THERE WAS NO PARTICULAR TREATMENT, AND IT BECAME TOLERANT IN ONE WEEK.

  Patient problems: Abscess; Pressure Sore/Ulcer

  MAUDE report 19560760 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K993637. One submission often covers many models, so check the product and lot details in each record.

• Z-0665-05 · Oct 18, 2004 · Terminated
  Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.