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Devon 31159422Recalls & reported problems

Cardinal Health, Inc. · Light Sleeve · 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 10884521128422), received between May 11, 2020 and May 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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

  • Crack1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionMay 11, 2020Crack; Crack

    THE CUSTOMER REPORTED THAT THE LIGHT HANDLE COVER BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10043625 ↗

Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices

All INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices →

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