CONVERTORS AT74531Recalls & reported problems
Cardinal Health 200, LLC · Procedure Mask W/Anti-Fog Foam Strip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20885380072113), received between Jan 24, 2017 and May 31, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility1
Patient problems
- Rash3
- Swelling1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2020Adverse Event Without Identified Device or Use Problem
EMPLOYEE IN IMAGING SERVICES REPORTED DEVELOPING SKIN IRRITATION/RASH AFTER WEARING MASK. EMPLOYEE HAS A LATEX ALLERGY. SHE WENT TO THE EMERGENCY DEPARTMENT WITH EYE SWELLING AND WAS GIVEN ORAL PREDNISONE. EMPLOYEE FINISHED PREDNISONE DOSE PACK AND REPORTS SHE IS DOING FINE NOW.
Patient problems: Rash
MAUDE report 10103897 ↗InjuryFeb 17, 2019Adverse Event Without Identified Device or Use Problem
NURSE¿S FACE WAS ITCHY/RED/BROKE OUT IN RASH AND HIVES; AND LATER THAT NIGHT HER FACE BECAME SWOLLEN. THE NEXT DAY SHE WENT TO THE URGENT CARE BECAUSE HER FACE WAS STILL SWOLLEN AND BROKEN OUT. SHE RECEIVED A STEROID INJECTION, PO STEROIDS, AND PO ANTIHISTAMINES. THESE HELPED, AND HER FACE WENT BACK TO NORMAL WITHIN A FEW DAYS.
Patient problems: Rash; Swelling
MAUDE report 8346505 ↗InjuryJan 24, 2017Patient-Device Incompatibility
NURSE HAD BEEN USING MASK WITHOUT PROBLEMS. ON (B)(6) 2016 NURSE HAD HER NOSE, CHEEKS, BEHIND HER EARS, AND ARMS BREAK OUT WITH A RASH. SHE WENT TO OCCUPATIONAL HEALTH AND WAS GIVEN AN ANTIHISTAMINE AND TOPICAL OINTMENT.
Patient problems: Rash
MAUDE report 6274370 ↗
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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