The Recall Desk
HighFDA (Devices)·Z-1058-2019·Announced 2019-04-03

Sunset Compressor Nebulizer Recalled for Overheating and Mouthpiece Detachment Risk

SANRAI INTERNATIONAL LLC is recalling 150 Sunset Compressor Nebulizer units in South Africa due to voltage incompatibility risks.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (overheating and component detachment) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

SANRAI INTERNATIONAL LLC is recalling 150 units of the Sunset Compressor Nebulizer, Model NEB100, in South Africa. The recall involves units with lot number 180223 that were distributed internationally to South Africa.

The device was designed for 120V usage but is being used in South Africa with 220V power. This voltage mismatch creates a potential for the device to overheat and for the mouthpiece to pop off during use.

Consumers who have this specific model and lot number should stop using the device immediately and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulizer is an AC-powered air nebulizer compressor system intended to provide a source of compressed air for medical purposes for use in home healthcare. It is to be used with a nebulizer kit to pro
Manufacturer
SANRAI INTERNATIONAL LLC
Category
Medical Device — Nebulizer
Hazard
Affected units
150

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number 180223

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · overheating

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