Sunset Compressor Nebulizer — Class II medical device recall Z-1058-2019
Terminated recall by SANRAI INTERNATIONAL LLC, reported 2019-04-03. The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for
| Recall number | Z-1058-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SANRAI INTERNATIONAL LLC, Endicott, NY, United States |
| Recall initiated | 2018-08-29 |
| Classified | 2019-03-26 |
| Reported by FDA | 2019-04-03 |
| Terminated | 2020-06-12 |
| Countries outside the US | ZA |
| Quantity | 150 units |
| Reason classes | device malfunction |
| Lot numbers | 180223 |
| Model numbers | NEB100 |
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 produce medicated aerosol particles for respiratory therapy for both children and adults.
Reason for recall
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1058-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.