Nellcor D25LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884522000851), received between Jan 17, 2023 and Jan 17, 2023 — 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.

• InjuryJan 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE REPORTER, DURING USE, ABOUT 7 HOURS AFTER THE SENSOR WAS PUT ON, THE PATIENT'S FINGER WHERE IT WAS WORN ON WAS TINGLING. WHEN THE NURSE CHECKED THE PART IT WAS WORN ON, THERE WAS A SMALL BLISTER ON THE NAIL ROOT (LUNULA SIDE) SKIN. THE BLISTERS IN THE PART WHERE IT WAS FIRST WORN ON HAD EXPANDED FROM THE FOLLOWING DAY, SO IT WAS DIAGNOSED BY A DERMATOLOGIST AS A MEDICAL-RELATED DEVICE COMPRESSION WOUND OR A LOW TEMPERATURE BURN.

  Patient problems: Blister; Burn(s); Joint Contracture; Partial thickness (Second Degree) Burn

  MAUDE report 16184784 ↗

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.