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POSEY 6554Recalls & reported problems

Posey Products, LLC · POSEY OXIMETER PROBE WRAP · Class 1

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 10190676001856), received between Oct 14, 2022 and Oct 14, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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

  • Loss of or Failure to Bond1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

    CUSTOMER REPORTED VIA EMAIL THE VELCRO APPEARS TO BE DIFFERENT AND THE WHITE STRIP OF CLOTH, LOCATED ON THE FOAM DOES NOT ADHERE WELL TO THE FOAM. THE NEW ONES FALL APART VERY QUICKLY. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO INCIDENT OR SERIOUS INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15611661 ↗

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