MEDLINE INDUSTRIES, INC. HCSMONKEYRecalls & reported problems
Medline Industries, Inc. · COMPRESSOR,NEBULIZER, CHARACTER, MONKEY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884389106894), received between Dec 10, 2024 and Sep 29, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (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.
Reports received per month
Most reported problems
Device problems
- Restricted Flow rate2
- Appropriate Device Problem Term/Code Not Available1
- Decrease in Pressure1
- Detachment of Device or Device Component1
- Failure to Power Up1
- Gas Output Problem1
- Infusion or Flow Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936644 ↗MalfunctionSep 25, 2026Smoking; Unexpected Shutdown
It was reported that "THE NEBULIZER JUST KEEPS TURNING OFF- THIS IS NOT WORKING" and "one started smoking - one was turning off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896338 ↗MalfunctionSep 22, 2026Gas Output Problem; Detachment of Device or Device Component
It was reported that the nebulizer has no power.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852976 ↗MalfunctionSep 18, 2026Restricted Flow rate; Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50827925 ↗MalfunctionSep 17, 2026Restricted Flow rate; Decrease in Pressure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809559 ↗MalfunctionSep 17, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805243 ↗MalfunctionFeb 4, 2025Infusion or Flow Problem; Infusion or Flow Problem
NOT DISPENSING MEDICATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21303668 ↗InjuryJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, ON 11/10 THE DEVICE HAS A WEIRD SOUND EFFECT ON THE INSIDE. THE CUSTOMER IS NOT ABLE TO USE THE MEDICATION UNLESS IT IS GIVEN IN THE HOSPITAL SINCE HE IS NOT RECEIVING THE NEBULIZER FROM THE MACHINE.
Patient problems: Insufficient Information
MAUDE report 21139867 ↗MalfunctionDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
Other Compressor, air, portable devices
- Medline HCS70004Medline Industries, Inc. · Compressor, air, portable386 reports
- Medline HCS70004RDMedline Industries, Inc. · Compressor, air, portable108 reports
- Compressor Mini 115V 60Hz 6481779Maquet Critical Care AB · Compressor, Air, Portable108 reports
- Life2000 MS-01-0093Welch Allyn, Inc. · Compressor, air, portable1 recall1 death5 reports
- Life2000 MS-01-0121Welch Allyn, Inc. · Compressor, air, portable1 recall0 reports
- Life2000 MS-01-0125Welch Allyn, Inc. · Compressor, air, portable1 recall0 reports
- InnoSpire Elegance 00Respironics Respiratory Drug Delivery (Uk) Ltd · Compressor, air, portable19 reports
- InnoSpire Essence 00Respironics Respiratory Drug Delivery (Uk) Ltd · Compressor, air, portable18 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page