Devon 31140273Recalls & reported problems
Cardinal Health 200, LLC · Devon Light Handle Cover · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20884527011596), received between Feb 13, 2020 and Sep 15, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
- Tear, Rip or Hole in Device Packaging2
- Material Split, Cut or Torn1
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
THE CUSTOMER REPORTED THE PRODUCT IS TORN AT THE EDGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10534908 ↗MalfunctionFeb 13, 2020Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging
THE CUSTOMER REPORTED THAT THE PACKAGING OF THE LITE SLEEVES WAS DAMAGED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE LITE SLEEVES WERE BROKEN AS WELL. THIS ISSUE WAS DISCOVERED UPON OPENING THE BOXES.
Patient problems: No Patient Involvement
MAUDE report 9708421 ↗MalfunctionFeb 13, 2020Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging
THE CUSTOMER REPORTED THAT THE PACKAGING OF THE LITE SLEEVES WAS DAMAGED. ADDITIONAL INFORMATION PROVIDED STATED THAT THE LITE SLEEVES WERE BROKEN AS WELL. THIS ISSUE WAS DISCOVERED UPON OPENING THE BOXES.
Patient problems: No Patient Involvement
MAUDE report 9708400 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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