Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2478-2026Class II

Mito Red Light, Super Mobile

Mito Red Light LLC / initiated 2025-02-12 / Open, Classified

MITO RED LIGHT INC began a recall of Mito Red Light, Super Mobile on . FDA classified it as Class II and gives the reason as "The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2478-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Mito Red Light LLC
Product
Mito Red Light, Super Mobile
Product code
ILY Lamp, Infrared, Therapeutic Heating
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 root cause
Under Investigation by firm
Action
Beginning 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: [email protected], website: mitoredlight.com/pages/recall to request a replacement device.
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.
Product codes and lots
All Serial/Lot numbers/No UDI

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2478-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2478-2026Class IIOngoingVoluntary: Firm initiated