HUDSON RCI IPN049319Recalls & reported problems

Teleflex Incorporated · Volumetric Exerciser · Class 2

All models of HUDSON RCI (152)

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 14026704630209), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

Physical Resistance/Sticking1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionAug 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED THAT "WHEN THE PATIENT BREATHES THE FLOW CUP DID NOT GO UP". PATIENT CONDITION UNKNOWN AT TIME OF REPORT.
Patient problems: Insufficient Information
MAUDE report 12377842 ↗

Device details

UDI-DI	`14026704630209`
Brand	HUDSON RCI
Model	IPN049319
Catalog no.	8884719033
Company	Teleflex Incorporated
Product code	BWF · SPIROMETER, THERAPEUTIC (INCENTIVE)
Class	Class 2
FDA submission	K801199
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Nov 17, 2023

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.

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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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