MediTec 0721109USRecalls & reported problems

GCE, s.r.o. · The regulator acts as a pressure-reducer, gas from the cylinder valve passes through the pressure regulator to the user outlets. · Class 1

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 08592346818088), received between May 2, 2024 and May 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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

Inaccurate Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMay 2, 2024Inaccurate Information; Inaccurate Information
THE BOX LABEL HAS THE WRONG FINAL PRODUCT NUMBER (REF). THERE WAS COMPLETELY CORRECT MARKING ON THE MEDICAL DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19227588 ↗

Device details

UDI-DI	`08592346818088`
Brand	MediTec
Model	0721109US
Catalog no.	MTC25 O2 CGA540 DS _ 9/16 S
Company	GCE, s.r.o.
Product code	CAN · Regulator, Pressure, Gas Cylinder
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Nov 21, 2025

Device type (GMDN): Non-fixed medical gas cylinder regulator

A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.

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