CARDINAL HEALTH 3274Recalls & reported problems
Cardinal Health 200, LLC · BLUE COMFORT BOUFFANT 24 IN · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20885380019798), received between Oct 18, 2018 and Oct 18, 2018 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use 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.
InjuryOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE END USER-CLINICIAN EXPERIENCED RASH FROM THE ELASTIC ON BOUFFANT CAP ON FOREHEAD.
Patient problems: Skin Irritation
MAUDE report 7981447 ↗
Other CAP, SURGICAL devices
- Halyard 69110O&M Halyard, Inc. · CAP, SURGICAL1 recall0 reports
- Halyard 69520O&M Halyard, Inc. · CAP, SURGICAL1 report
- MEDLINE INDUSTRIES, INC. CRI1004Medline Industries, Inc. · CAP, SURGICAL1 report
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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