AirLife 001902ARecalls & reported problems

Airlife · AirLife™ Volumetric Incentive Spirometer, 4000 ml · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752131064), received between Aug 31, 2022 and Aug 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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

Material Fragmentation1

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.

InjuryAug 31, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO VYAIRE MEDICAL THAT WHILE A PATIENT WAS USING THE INCENTIVE SPIROMETER, THE PATIENT INHALED AND FELT SOMETHING IN THE BACK OF THEIR THROAT. AFTER THE FIRST BREATH, A SMALL PIECE OF PLASTIC WAS COUGHED UP. THE CUSTOMER CONFIRMED THAT NO FURTHER HARM WAS NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15332425 ↗

Device details

UDI-DI	`10190752131064`
Brand	AirLife
Model	001902A
Company	Airlife
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

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1 recall1 report
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HUDSON RCI IPN049316
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3 reports
Portex 22-4000
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2 reports
Portex 27-9000
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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 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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