Portex 22-2500Recalls & 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 10788942225008), received between Apr 12, 2022 and Apr 12, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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.

Most reported problems

Device problems

Component Missing1
Device Damaged Prior to Use1

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.

MalfunctionApr 12, 2022Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing
IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE BOTTOM PART OF THE PRODUCT WAS CHIPPED (AND/OR MISSING). NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14085881 ↗

Device details

UDI-DI	`10788942225008`
Brand	Portex
Model	22-2500
Company	Icu Medical, Inc.
Product code	BWF · SPIROMETER, THERAPEUTIC (INCENTIVE)
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	Apr 17, 2025

Device type (GMDN): Incentive spirometer

A hand-held, mechanical, breathing-muscle exerciser intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility and in the home. This is a reusable device.

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 27-9001
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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