Halyard 47080Recalls & reported problems
O&M Halyard, Inc. · PROC,-,MASK,BU,-,500 · Class 2
Data updated Oct 13, 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 20680651470809), received between Mar 15, 2017 and Mar 15, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Emits Odor” (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
- Device Emits Odor1
Patient problems
- Asthma1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2017Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT AFTER WEARING THE MASK, A NURSE EXPERIENCED AN ASTHMA ATTACK WITH SHORTNESS OF BREATH AND ELEVATED HEART RATE. THE NURSE FEELS IT WAS DUE TO AN ALLERGIC REACTION TO THE MASK. THE HOSPITAL ALLEGES THERE IS AN ODOR BUT HAS PROVIDED NO FURTHER DETAILS AT THIS TIME.
Patient problems: Asthma; No Code Available
MAUDE report 6406761 ↗
Other Mask, surgical devices
- Halyard 47117O&M Halyard, Inc. · Mask, surgical1 recall12 reports
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Medline NON27410Medline Industries, Inc. · Mask, surgical14 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- CONVERTORS AT70021Cardinal Health 200, LLC · Mask, surgical5 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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