Summary
The FDA issued a Class II for OttLite Rechargeable UVC Disinfecting Wand by Ottlite TEchnologies, Inc.. Reason: Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commiss.
Details
Source
Device Recall
External ID
Z-1473-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
OttLite Rechargeable UVC Disinfecting Wand
Lot/Code Info: model: UV10002M
Quantity Affected: 7376 units
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.
Distribution
US Natioonwide Distribution
Type: FDA Mandated
Recall Initiated: 2022-11-17
Company
Tampa, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ottlite TEchnologies, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ottlite TEchnologies, Inc. have FDA actions?
This is the only FDA action we have on record for Ottlite TEchnologies, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1473-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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