Portex 20-1112Recalls & 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 10788942211124), received between Jul 11, 2024 and Jul 11, 2024 — classified as 1 malfunction.

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

Reports received per month

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

Most reported problems

Device problems

Defective Component1

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.

MalfunctionJul 11, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE DEVICE WAS NOT FUNCTIONAL. THE PRESSURE INDICATOR OR PISTON DOES NOT RETURN TO INITIAL POSITION. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19722528 ↗

Device details

UDI-DI	`10788942211124`
Brand	Portex
Model	20-1112
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): 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
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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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