Portex 20-0050Recalls & reported problems

All models of Portex (409)

Data updated Oct 16, 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 10788942200500), received between May 20, 2024 and May 20, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Defective Device1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

MalfunctionMay 20, 2024Defective Device; Defective Device
IT WAS REPORTED BY THE PATIENT THAT "THE MACHINE HAS NOT BEEN WORKING, AND HER CONDITION IS CRITICAL. UNABLE TO BREATHE WITHOUT THE MACHINE AND HAS SHORTNESS OF BREATH". ADDITIONAL ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19355707 ↗

Device details

UDI-DI	`10788942200500`
Brand	Portex
Model	20-0050
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): Breathing mouthpiece, reusable

A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.

Other SPIROMETER, THERAPEUTIC (INCENTIVE) devices

Portex 21-1530
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 recall1 report
HUDSON RCI IPN049141
Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)
3 reports
HUDSON RCI IPN049316
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
HUDSON RCI IPN049142
Teleflex Incorporated · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 report
Portex 22-2500
Icu Medical, Inc. · SPIROMETER, THERAPEUTIC (INCENTIVE)
1 report
Portex 27-9001
Icu Medical, 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 13, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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