Medline HCSPUPPYRDRecalls & reported problems
Medline Industries, Inc. · COMPRESSOR,NEBULIZER, PUPPY, RD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888277697198), received between May 5, 2026 and Sep 25, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (1 report).
1 other recall cover devices cleared under the same FDA submission (K091272); they may or may not involve this specific model.
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
- Failure to Deliver1
- Failure to Power Up1
- No Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Deliver
It was reported that the nebulizer was dropped and since the drop it is no longer misting or disbursing medication.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899225 ↗MalfunctionSep 22, 2026Failure to Power Up
It was reported that the power button is broke and the device does not always turn on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858155 ↗MalfunctionMay 5, 2026No Pressure
ACCORDING TO THE CUSTOMER, THE NEBULIZER STOPPED WORKING AND IT HAS NO PRESSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087118 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091272. One submission often covers many models, so check the product and lot details in each record.
- Z-1058-2019 · Aug 29, 2018 · TerminatedSunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compress
Other Nebulizer (direct patient interface) devices
- HUDSON RCI IPN049807Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)62 reports
- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 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.
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