CLASS III Device recall · Reported 31 Jul 2013 · FDA Enforcement Report

Dermalight 80 Model Number Uvb-080, one unit per box. The Dermalight recalled

National Biological is recalling Dermalight 80 Model Number Uvb-080, one unit per box. The Dermalight, distributed nationwide in the US. The recall was initiated on 9 Apr 2013 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesThe following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.

Quantity recalled124 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-1778-2013
FDA event ID: 65488
Recalling firm: National Biological, Beachwood, OH
Classification: Class III
Status: Terminated
Recall initiated: 9 Apr 2013
FDA classified: 19 Jul 2013
Reported: 31 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

9 Apr 2013	Recall initiated by company
19 Jul 2013	Classified by FDA	+101 days
31 Jul 2013	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 incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

Where it was distributed

Worldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.

Nationwide Alabama California Colorado Connecticut Florida Georgia Iowa Idaho Illinois Louisiana Massachusetts Minnesota Missouri Mississippi Nebraska New Jersey New York Ohio Pennsylvania South Carolina

Questions about this recall

Is Dermalight 80 Model Number Uvb-080, one unit per box. The Dermalight recalled?

Yes. National Biological recalled Dermalight 80 Model Number Uvb-080, one unit per box. The Dermalight on 9 Apr 2013. The recall is Class III and its status is Terminated. Recall number Z-1778-2013.

Why was it recalled?

The incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.

Which lots are affected?

The following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.

Where was it sold?

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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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5 Apr 2017Device	CLASS II	Hand Foot II, UVB recalled by National Biological	National Biological	Other	6 states
31 Jul 2013Device	CLASS III	Dermalight 80 Model Number Uvb-083, one unit per box. The Dermalight recalled	National Biological	Packaging Defects	4 states

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