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Nellcor POSEYRecalls & reported problems

Covidien LP · Sensor Wraps;For use with OXI-A/N, OXI-P/I, D-YS. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521144897), received between Nov 25, 2019 and Nov 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K012891); 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

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • Skin Irritation1

Recent adverse event reports

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

  • MalfunctionNov 25, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

    ACCORDING TO THE REPORTER, THE DEVICE HAD A SKIN INTEGRITY ISSUE. THE PATIENT HAD SCRATCHES AND MARKS ON THE FOOT.

    Patient problems: Skin Irritation

    MAUDE report 9372713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012891. One submission often covers many models, so check the product and lot details in each record.

  • Z-0664-05 · Oct 18, 2004 · Terminated
    Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.

Other Oximeter devices

All Oximeter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.