CONVERTORS AT70021Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20885380071994), received between Nov 8, 2016 and Dec 7, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INCIDENT WAS REPORTED FOR AN ASSOCIATE THAT EXPERIENCED AN ALLERGIC REACTION TO A CARDINAL HEALTH MASK. THE TEAM MEMBER HAD TO BE PRESCRIBED A 7-DAY TREATMENT OF PREDNISONE TO TREAT SEVERE DERMATITIS. WE HAVE NOT RECEIVED ANY ADDITIONAL FOLLOW UP AFTER SEVERAL REQUESTS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12956663 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THROUGH MEDWATCH REPORT #MW5103107 THAT THEY RECEIVED CHEMICAL BURNS/RASH AFTER WEARING A CARDINAL HEALTH LEVEL 1 PROCEDURE MASK. ACCORDING TO REPORT, THEIR FACE BEGAN TO STING AND PEEL. THEY ALSO HAD CHEMICAL BURNS ON THEIR NOSE, INNER EYE, AND CHEEK AREA FROM THE MASK. NO FURTHER INFORMATION WAS PROVIDED AFTER MULTIPLE ATTEMPTS TO REACH CUSTOMER.

  Patient problems: Caustic/Chemical Burns; Rash

  MAUDE report 12641046 ↗
• InjuryMar 17, 2019Adverse Event Without Identified Device or Use Problem

  NURSE WORE MASK MAJORITY OF SHIFT. NOTICED NOSE/NECK/LOWER JAWLINE WAS RED AND IRRITATED - IRRITATED AREAS PROCEEDED TO A RED RASH. SAW FAMILY PHYSICIAN WHO THOUGHT IT WAS CONTACT DERMATITIS FROM THE MASK AND PRESCRIBED PREDNISONE AND ZANTAC. SYMPTOMS PERSISTED EXTENDING TO LOWER NECK, THROAT (IRRITATED, GLANDS SWOLLEN), AND HANDS HAVING RASH ON KNUCKLES. SHE THEN SAW THE EMPLOYEE HEALTH PHYSICIAN WHO BELIEVED IT WAS AN ALLERGY TO LATEX. SHE IS TAKING A TAPERING PACK OF METHYLPREDNISONE AND HYDROCORTISONE CREAM, AND IS TO SEE AN ALLERGIST. THE NURSE IS NOT CERTAIN IF THE MASK CAUSED HER SYMPTOMS. CARDINAL HEALTH IS PROACTIVELY FILING THIS.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Irritation; Rash; Swelling

  MAUDE report 8427272 ↗
• InjuryMay 1, 2018Device Contamination with Chemical or Other Material

  NURSE WENT TO PUT ON A MASK AND WAS HIT WITH A WHITE POWDERY SUBSTANCE IN HER EYE. CUSTOMER STATES IT IS STANDARD POLICY FOR EMPLOYEES TO SEEK CARE/EVALUATION FROM EMPLOYEE HEALTH SERVICES. THE NURSE WAS NOT SYMPTOMATIC, BUT AS STANDARD PROTOCOL, AN EYEWASH WAS PERFORMED. THE NURSE IS A CONTRACTOR, SO THE CUSTOMER DID NOT HAVE ANY PERSONAL INFORMATION ABOUT HER.

  Patient problems: Foreign Body In Patient

  MAUDE report 7477283 ↗
• InjuryNov 8, 2016Patient-Device Incompatibility

  HOME DIALYSIS PATIENT RECEIVED MASKS THAT HE SAYS ARE DUSTY/HAVE LOTS OF LINT AND MAKE HIM COUGH/SNEEZE/GET A SORE THROAT. HE SAW HIS FAMILY PHYSICIAN AND WAS DIAGNOSED WITH BRONCHITIS, WHICH HE STATES HIS PHYSICIAN SAID IS DUE TO THE MASKS. HE WAS PRESCRIBED ANTIBIOTICS. HE IS NOW USING A DIFFERENT MASK, APPARENTLY WITHOUT PROBLEMS.

  Patient problems: Bronchitis; Sore Throat

  MAUDE report 6086491 ↗