MEDLINE HCSU4483Recalls & reported problems

Medline Industries, Inc. · NEBULIZER,KIT,TMTHPIECE,6""RESER,7'TUB,UC · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277657625), received between Aug 28, 2018 and Jan 18, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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

Leak/Splash2
Connection Problem1
Disconnection1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Respiratory Distress1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryJan 18, 2023Disconnection; Leak/Splash; Connection Problem; Disconnection; Leak/Splash; Connection Problem
ACCORDING TO THE FACILITY AFTER THE NEBULIZER IS SETUP AT THE BEDSIDE THE "TUBING POPS OFF FROM THE FLOWMETER OR THE BOTTOM OF THE NEB CUP WHILE ALSO LEAKING".
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16195516 ↗
MalfunctionAug 28, 2018Leak/Splash
EQUIPMENT DEFECT, SMALL VOLUME NEBULIZER POWER SOURCE TUBING LEAK, DELAYED TREATMENT OF RESPIRATORY DISTRESS, INHALATION AEROSOL THERAPY. RECURRENT ISSUES.
Patient problems: Respiratory Distress
MAUDE report 7826532 ↗

Device details

UDI-DI	`10888277657625`
Brand	MEDLINE
Model	HCSU4483
Company	Medline Industries, Inc.
Product code	CAF · Nebulizer (direct patient interface)
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	Jul 16, 2026

Device type (GMDN): Nebulizing system delivery set, single-use

A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

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All Nebulizer (direct patient interface) 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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