Summary
The FDA issued a Class II for Mito Red Light, Super Mobile by MITO RED LIGHT INC. Reason: The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames..
Details
Source
Device Recall
External ID
Z-2478-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
Mito Red Light, Super Mobile
Lot/Code Info: All Serial/Lot numbers/No UDI
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.
Distribution
Worldwide - 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-12
Company
Scottsdale, AZ
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 254 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 (MITO RED LIGHT INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MITO RED LIGHT INC have FDA actions?
This is the only FDA action we have on record for MITO RED LIGHT INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2478-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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