Portex 23-0757Recalls & reported problems

All models of Portex (409)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10788942207578), received between Oct 26, 2022 and Oct 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Device Markings/Labelling Problem1

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.

MalfunctionOct 26, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AFTER RECEIVING THE PRODUCTS, IN THE PACKAGE INCLUDED A PRESSURE GAUGE, WHICH IS NORMALLY NOT INCLUDED WITH THIS PRODUCT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15674516 ↗

Device details

UDI-DI	`10788942207578`
Brand	Portex
Model	23-0757
Company	Icu Medical, Inc.
Product code	BWF · SPIROMETER, THERAPEUTIC (INCENTIVE)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2025

Device type (GMDN): CPAP/BPAP oral mask

A flexible, form-shaped device designed to be fitted to the user's mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the patient's mouth; this providing a solution for mouth breathers and patients with chronic nasal obstruction. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Other SPIROMETER, THERAPEUTIC (INCENTIVE) devices

Portex 21-1530
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1 recall1 report
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3 reports
HUDSON RCI IPN049141
Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)
3 reports
Portex 22-4000
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
2 reports
Portex 27-9000
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
2 reports
Portex 27-9001
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 report
Portex 22-2500
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 report
HUDSON RCI HUD8884719010
Medline Industries, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 report

All SPIROMETER, THERAPEUTIC (INCENTIVE) devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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