Com-Fit® 20346Recalls & reported problems

Sultan Healthcare Inc · Super Sensitive com-fit® mask Earloop Box of 50 · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D687203461), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Patient-Device Incompatibility1

Patient problems

Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

MalfunctionDec 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT, IT IS REPORTED THAT DURING USE OF COMFIT SUPER SENSITIVE EAR LOOP WHITE - BOX OF 50 EA, IT IS ALLEGED THAT AN ALLERGIC REACTION OCCURRED. NO INJURY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 23758773 ↗

Device details

UDI-DI	`D687203461`
Brand	Com-Fit®
Model	20346
Company	Sultan Healthcare Inc
Product code	FXX · Mask, surgical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 6, 2020

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.

Other Mask, surgical devices

Halyard 47117
O&M Halyard, Inc. · Mask, surgical
1 recall12 reports
Halyard 47147
O&M Halyard, Inc. · Mask, surgical
1 recall1 report
Halyard 47500
O&M Halyard, Inc. · Mask, surgical
1 recall0 reports
Henry Schein 5702448
Henry Schein, Inc. · Mask, surgical
1 recall0 reports
Criterion 5703281
Henry Schein, Inc. · Mask, surgical
1 recall0 reports
Medline NON27410
Medline Industries, Inc. · Mask, surgical
14 reports
UltraTM Earloop Mask GCFCXS
Crosstex International, Inc. · Mask, surgical
8 reports
CONVERTORS AT70021
Cardinal Health 200, LLC · Mask, surgical
5 reports

All Mask, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.