CLASS II ONGOING Device recall · Reported 4 Oct 2023 · FDA Enforcement Report
ProSun International Luxura Vegaz recalled by J&T Health and Wellness
J&T Health and Wellness is recalling ProSun International Luxura Vegaz. The recall was initiated on 31 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2636-2023
- FDA event ID
- 92217
- Recalling firm
- J&T Health and Wellness, Saint Petersburg, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Mar 2023
- FDA classified
- 28 Sep 2023
- Reported
- 4 Oct 2023
- Type
- N/A
- Customers notified by
- N/A
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 31 Mar 2023 | Recall initiated by company | |
| 28 Sep 2023 | Classified by FDA | +181 days |
| 4 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Where it was distributed
US
Questions about this recall
Why was it recalled?
In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.
Which lots are affected?
52X0012, 52X0013, 52X0014, 52X0024, 52X0029, 52X0030, 52X0031, 52X0032, 52X0033, 52X0034, 52X0036, 52X0037
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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