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U.S. Department of Health and Human Services

Class 2 Device Recall Mito Red Light, Super Mobile

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 Class 2 Device Recall Mito Red Light, Super Mobilesee related information
Date Initiated by FirmFebruary 12, 2025
Date PostedJune 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2478-2026
Recall Event ID 98999
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
ProductMito Red Light, Super Mobile
Code Information All Serial/Lot numbers/No UDI
FEI Number 3015313684
Recalling Firm/
Manufacturer		 MITO RED LIGHT INC
9319 N 94th Way Ste 400
Scottsdale AZ 85258-5565
For Additional Information ContactMito Red Light Customer Safety Team
866-861-6486
Manufacturer Reason
for Recall		The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
FDA Determined
Cause 2		Under Investigation by firm
ActionBeginning on on February 12, 2025, Mito Red Light LLC issued a recall notification to affected consignees in a variety of methods. Mito Red Light is asking consignees to take the following actions: 1. Immediately stop using the mito Mobile Super. 2. Do not charge the device. Disconnect any chargers from the device and rom any power outlet. 3. Store the device away from flammable materials, in a cool dry place, until you can dispose of it. 4. Contact Mito Mobile at 1-866-861-6486 , Email: recall@mitoredlight.com, website: mitoredlight.com/pages/recall to request a replacement device.
DistributionWorldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Canada, China, Japan, New Zealand, Spain, Switzerland, United Arab Emirates, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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