Q-Mix QMIX60MLRecalls & reported problems

Tulsa Dental Products LLC · QMix 2in1 Endodontic Irrigating Solution - 60 ML · Class U

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 D716QMIX60ML1), received between Apr 28, 2025 and Apr 28, 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.

MalfunctionApr 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IN THIS EVENT IT IS REPORTED THAT A PATIENT HAD A REACTION TO THE QMIX 2 IN 1 60ML PACKAGE. FURTHER INFORMATION REQUESTED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21919883 ↗

Device details

UDI-DI	`D716QMIX60ML1`
Brand	Q-Mix
Model	QMIX60ML
Company	Tulsa Dental Products LLC
Product code	KJJ · CLEANSER, ROOT CANAL
Class	Class U
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 25, 2022

Device type (GMDN): Root canal cleaning solution

A fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.

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