Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1473-2023Class II

OttLite Rechargeable UVC Disinfecting Wand

Ottlite TEchnologies, Inc. / initiated 2022-11-17 / Open, Classified

Ottlite TEchnologies, Inc. began a recall of OttLite Rechargeable UVC Disinfecting Wand on . FDA classified it as Class II and gives the reason as "Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commission on Non-ionizing Radiation Protection (ICNIRP). The emissions are...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1473-2023
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Ottlite TEchnologies, Inc.
Product
OttLite Rechargeable UVC Disinfecting Wand
Product code
RHP Uv Lamp, Germicidal
Reason for recall
Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commission on Non-ionizing Radiation Protection (ICNIRP). The emissions are hazardous to users and others in the vicinity.
FDA root cause
Radiation Control for Health and Safety Act
Action
OttLite, sent consumers a Notification letter. The letter identified the affected product, problem and actions to be taken. Consumers should immediately stop using the recalled product and return the item to OttLite to receive a replacement product. The letter provided instructions for returning your OttLite Rechargeable UVC Disinfecting Wand (model: UV10002M) to Ottlite. 1. Go to our website at: www.OttLite.com/Recall 2. Fill out the form at the website including letting us know if you still have the UV10002M UV Wand in your possession. 3. Copy your purchase receipt and submit it on the website form. a. We will contact you and send a postage paid return envelope to return the wand if you still have it in your possession. 4. Once OttLite receives the consumer s information, we will ship a replacement Ottlite UVC Disinfecting Phone Case with Wireless Charging to the address you entered in the website.
Quantity in commerce
7376 units
Distribution
US Natioonwide Distribution
Product codes and lots
model: UV10002M

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1473-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1473-2023Class IIOngoingFDA Mandated