FDA Medical Device Recalls (openFDA)
SANRAI INTERNATIONAL LLC: 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.
- Recall number
- Z-1058-2019
- Recalling firm
- SANRAI INTERNATIONAL LLC
- 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.
- Status
- Terminated
- Initiated
- 2018-08-29
- Posted
- not on file
- Terminated
- 2020-06-12
- Reason
- 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.
- Root cause
- Device Design
- Action
- Notification letters were distributed to customers on 8/29/18.
- Quantity
- 150 units
- Distribution
- International distribution in the country of South Africa.
- Lot, serial or model codes
- Lot number 180223
- 510(k) numbers
- ["K091272"]
- PMA numbers
- not on file
- Product code
- CAF
- Firm FEI
- 3014347367
- Firm city
- Endicott
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28