CLASS II Device recall · Reported 17 Jan 2018 · FDA Enforcement Report

Sundream 12 V tanning bed recalled by ProSun International

ProSun International is recalling Sundream 12 V tanning bed, distributed in 33 states. The recall was initiated on 2 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. 12V, Serial No. SUN12VH1R0006, SUN12VH1R0005, SUN12VH1R0001, SUN12VH1R0004, SUN12VH1R0002, SUN12VH1R0003, SUN12VH1R0007, SUN12VH1R1001, SUN12VH1R0011, SUN12VH1R0012, SUN12VH1R0013, SUN12VH1R0009, SUN12VH1R0010, SUN12VH1R0016, SUN12VH1R0015, SUN12VH1R0017, SUN12VH1R0018, SUN12VH1R0022, SUN12VH1R0021, SUN12VH1R0019, SUN12VH1R0020, SUN12VH1R0023, SUN12VH1R0024, SUN12VH1R0026, SUN12VH1R0027, SUN12VH1R0025, SUN12VH1R0028, SUN12VH1R0033, SUN12VH1R0036, SUN12VH1R0039, SUN12VH1R0041, SUN12VH1R0042, SUN12VH1R0047, SUN12VH1R0043, SUN12VH1R0045, SUN12VH2R0032, SUN12VH1R0040, SUN12VH1R0031, SUN12VH1R0044, SUN12VH1R0050, SUN12VH1R0049, SUN12VH1R0048, SUN12VH1R0055, SUN12VH1R0056, SUN12VH1R0054, SUN12VH1R0057, SUN12VH1S0060, SUN12VH1S0059, SUN12VH1S0058, SUN12VH1R0052, SUN12VH1S0061, SUN12VH1S0062, SUN12VH1R0051, SUN12VH4R0053, SUN12VH1S0063, SUN12VH1S0066, SUN12VH1S0064, SUN12VH1S0065, SUN12VH1S0071, SUN12VH1S0070, SUN12VH1S0068, SUN12VH1S0073, SUN12VH1R0072, SUN12VH1S0075, SUN12VH1S0067, SUN12VH1S0076, SUN12VH1S0069, SUN12VH1S0074, SUN12VH1S0077, SUN12VH1S0079, SUN12VH2S0080, SUN12VH1S0086, SUN12VH2S0081, SUN12VH1R0087, SUN12VH1R0088

Quantity recalled75 units

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-0319-2018
FDA event ID: 78571
Recalling firm: ProSun International, Saint Petersburg, FL
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2017
FDA classified: 5 Jan 2018
Reported: 17 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Dec 2017	Recall initiated by company
5 Jan 2018	Classified by FDA	+34 days
17 Jan 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The 30 minute maximum tanning time has been reduced to 20 minutes.

Product as listed by the FDA

Sundream 12 V tanning bed

Where it was distributed

Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI

Alaska Alabama Arizona California Connecticut Florida Georgia Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina

Questions about this recall

Is Sundream 12 V tanning bed recalled?

Yes. ProSun International recalled Sundream 12 V tanning bed on 2 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-0319-2018.

Why was it recalled?

The 30 minute maximum tanning time has been reduced to 20 minutes.

Which lots are affected?

Model No. 12V, Serial No. SUN12VH1R0006, SUN12VH1R0005, SUN12VH1R0001, SUN12VH1R0004, SUN12VH1R0002, SUN12VH1R0003, SUN12VH1R0007, SUN12VH1R1001, SUN12VH1R0011, SUN12VH1R0012, SUN12VH1R0013, SUN12VH1R0009, SUN12VH1R0010, SUN12VH1R0016, SUN12VH1R0015, SUN12VH1R0017, SUN12VH1R0018, SUN12VH1R0022, SUN12VH1R0021, SUN12VH1R0019, SUN12VH1R0020, SUN12VH1R0023, SUN12VH1R0024, SUN12VH1R0026, SUN12VH1R0027, SUN12VH1R0025, SUN12VH1R0028, SUN12VH1R0033, SUN12VH1R0036, SUN12VH1R0039, SUN12VH1R0041, SUN12VH1R0042, SUN12VH1R0047, SUN12VH1R0043, SUN12VH1R0045, SUN12VH2R0032, SUN12VH1R0040, SUN12VH1R0031, SUN12VH1R0044, SUN12VH1R0050, SUN12VH1R0049, SUN12VH1R0048, SUN12VH1R0055, SUN12VH1R0056, SUN12VH1R0054, SUN12VH1R0057, SUN12VH1S0060, SUN12VH1S0059, SUN12VH1S0058, SUN12VH1R0052, SUN12VH1S0061, SUN12VH1S0062, SUN12VH1R0051, SUN12VH4R0053, SUN12VH1S0063, SUN12VH1S0066, SUN12VH1S0064, SUN12VH1S0065, SUN12VH1S0071, SUN12VH1S0070, SUN12VH1S0068, SUN12VH1S0073, SUN12VH1R0072, SUN12VH1S0075, SUN12VH1S0067, SUN12VH1S0076, SUN12VH1S0069, SUN12VH1S0074, SUN12VH1S0077, SUN12VH1S0079, SUN12VH2S0080, SUN12VH1S0086, SUN12VH2S0081, SUN12VH1R0087, SUN12VH1R0088

Where was it sold?

Distributed domestically to AK, AL, AZ, CA, CT, FL, GA, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, WI

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 21 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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