Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 3, 2019
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.
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.
Sanrai International LLC recalled Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulize… - a moderate-severity action.
Sunset Compressor Nebulizer, Model NEB100 - Product Usage: The Sunset Compressor Nebulize… was recalled by Sanrai International LLC in April 3, 2019. Reason: The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential fo…. Check the official notice for the remedy. Verify recall #Z-1058-2019 with the FDA Devices before acting.
The recall
Sanrai International LLC issued this moderate-severity FDA Devices recall-The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential fo….
- Moderate
- severity level
- 150 units
- affected scope
- Class II
- classification
- April 3, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1058-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1058-2019) was formally reported on April 3, 2019, with the manufacturer initiating the action on August 29, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Sanrai International LLC is listed as the recalling firm, operating out of Endicott, NY. Federal records list the affected scope as 150 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: International distribution in the country of South Africa.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
150 units
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1058-2019 |
| Date reported | April 3, 2019 |
| Date initiated | August 29, 2018 |
| Recalling firm | Sanrai International LLC |
| Firm location | Endicott, NY |
| Affected scope | 150 units |
| Distribution | International distribution in the country of South Africa. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1058-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sanrai International LLC. Units affected: 150 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2019. Severity: Moderate. Recall number: Z-1058-2019.
Where was the recalled product distributed? ▼
Distribution: International distribution in the country of South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1058-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 3, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.