CONVERTORS AT73335Recalls & reported problems
Cardinal Health 200, LLC · Surgical Mask Dye-Free · 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 20885380072076), received between Jan 13, 2020 and Sep 16, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction2
- Burning Sensation1
- Dyspnea1
- Reaction1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2020Patient-Device Incompatibility
CONSUMER REPORTED ALLERGIC REACTIONS TO THE MASK AND HISTORY OF ALLERGIES. SHE REPORTS NEVER HAVING TO WEAR A SURGICAL MASK BEFORE, BUT NOW WEARS THE MASK FOR AT LEAST 12 HOURS DURING HER WORK DAY AND IS HAVING BREATHING PROBLEMS SUCH AS COUGHING, ASTHMA-LIKE SYMPTOMS. SHE IS THE ONLY ONE HAVING AN ALLERGIC REACTION.
Patient problems: Dyspnea; Hypersensitivity/Allergic reaction
MAUDE report 10540622 ↗InjuryJan 22, 2020Patient-Device Incompatibility
BASED ON INFORMATION RECEIVED AFTER A PHONE CONVERSATION WITH THE END-USER, SHE CLARIFIED THAT SHE DID GO TO THE EMERGENCY DEPARTMENT AFTER HAVING AN ALLEGED REACTION TO MASK AT73335, LOT NUMBER 19DGH616. SHE STATED SHE WAS PRESCRIBED 5-DAY ORAL STEROIDS AND HYDROCORTISONE CREAM 2%.
Patient problems: Reaction
MAUDE report 9617693 ↗InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem
BASED ON INFORMATION RECEIVED BY THE END-USER, EMPLOYEE (B)(6) REPORTEDLY WAS SEEN AT TWO DIFFERENT URGENT CARE CENTERS WITH ALLEGED SYMPTOMS OF A BURNING FEELING AROUND HER MOUTH, FACE AND NECK. SHE ALSO ALLEGES BREAKING OUT 2 TO 10 HOURS LATER THAT PROGRESSIVELY GOT WORSE. SHE WAS PRESCRIBED DECADRON AND HYDROCORTISONE 0.2% OINTMENT ON HER FIRST VISIT URGENT CARE VISIT. ON HER SECOND VISIT TO URGENT CASE SHE WAS PRESCRIBED PREDNISONE 5-DAY PACK AND TO CONTINUE USE OF TOPICAL CREAM AND BENADRYL.
Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction
MAUDE report 9582374 ↗
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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