CONVERTORS AT74535Recalls & reported problems

Cardinal Health 200, LLC · Surgical Mask W/Anti-Fog Foam Strip · 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 20885380072120), received between Jan 27, 2020 and Jan 27, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Short Fill” (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

Short Fill1

Patient problems

Reaction1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 27, 2020Short Fill
BASED ON INFORMATION RECEIVED AFTER PHONE CONVERSATION WITH THE END-USER, SHE CLARIFIED THAT SHE DID GO TO THE EMERGENCY DEPARTMENT AFTER HAVING AN ALLEGED REACTION TO MASK AT74535 (FOG FREE MASK) LOT NUMBER 19FLH293. SHE RECEIVED A PRESCRIPTION FOR 5-DAY STEROIDS; HOWEVER, SHE DID NOT FILL THE PRESCRIPTION AS SHE WAS SEEING HER DERMATOLOGIST THE NEXT DAY. AFTER SEE DERMATOLOGIST SHE RECEIVED AN 8-WEEK TREATMENT OF THE ANTIBIOTIC DOXYCYCLINE. SHE STATED SHE IS DOING MUCH BETTER.
Patient problems: Reaction
MAUDE report 9632161 ↗

Device details

UDI-DI	`20885380072120`
Brand	CONVERTORS
Model	AT74535
Company	Cardinal Health 200, LLC
Product code	FXX · Mask, surgical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 1, 2025

Device type (GMDN): Surgical/medical face mask, single-use

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

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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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