Food, drugs, devices › National Biological Corp
Device recall: Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultra
FDA enforcement event 65494 is a device recall by National Biological Corp of Beachwood, OH, initiated 8 Apr 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 24 Feb 2014. Initiation: voluntary: firm initiated. National Biological Corp has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
National Biological Corp, Beachwood, OH.
Reason for recall
"The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device."
Distribution
"US distribution including the states of: AL, CA, MN, and NC."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1779-2013 | Dermalight 80 Model Number UVB-083, 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. | 6 units | Class III | Terminated | 31 Jul 2013 |
Context
Other enforcement events for National Biological Corp
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Jan 2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV photothe | Device | Class II | 1 |
| 9 Apr 2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultra | Device | Class III | 1 |
All 3 events for National Biological Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution including the states of: AL, CA, MN, and NC."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Feb 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.