Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 24, 2019
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
ProSun International, LLC recalled ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the follow… - a moderate-severity action.
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the follow… was recalled by ProSun International, LLC in April 24, 2019. Reason: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which cou…. Check the official notice for the remedy. Verify recall #Z-1176-2019 with the FDA Devices before acting.
The recall
ProSun International, LLC issued this moderate-severity FDA Devices recall-ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which cou….
- Moderate
- severity level
- 177 units
- affected scope
- Class II
- classification
- April 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1176-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1176-2019) was formally reported on April 24, 2019, with the manufacturer initiating the action on December 10, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. ProSun International, LLC is listed as the recalling firm, operating out of Saint Petersburg, FL. Federal records list the affected scope as 177 devices of which 31 are affected.
The documented reason for this recall is: ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. Distribution data in the federal record shows the product reached: US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.. 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
177 devices of which 31 are affected
Related Recalls
6
6 from same agency
Product description
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
Reason for recall
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1176-2019 |
| Date reported | April 24, 2019 |
| Date initiated | December 10, 2018 |
| Recalling firm | ProSun International, LLC |
| Firm location | Saint Petersburg, FL |
| Affected scope | 177 devices of which 31 are affected |
| Distribution | US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI. |
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-1176-2019) 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? ▼
ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin. Recalled by ProSun International, LLC. Units affected: 177 devices of which 31 are affected.
Why was this product recalled? ▼
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1176-2019.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1176-2019) 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.
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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 24, 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.