Nellcor N25Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30884522001148), received between Jun 7, 2021 and Oct 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “High Readings” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, WHEN THE RIGHT WRIST WHERE THE SENSOR WAS PLACED WAS EXAMINED AFTER SIX HOURS IT WAS DISCOVERED THAT THERE WAS A COLD BURN. THERE WAS PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Burn(s)

  MAUDE report 12591145 ↗
• MalfunctionJun 7, 2021High Readings; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE HAD A HIGH SP02 READING VALUE; HOWEVER, AFTER REPLACING THE SENSOR, THERE WAS NO ABNORMALITY IN THE READING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945951 ↗

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.