FDA Medical devices recall ·

Mito Red Light, Super Mobile recall

Recall number
Z-2478-2026
Date
(initiated February 12, 2025)
Company / brand
Mito Red Light Inc
9319 N 94th Way Ste 400, Scottsdale, AZ, United States
Category
Medical devices › Class II
Classification
Class II
Status
Ongoing
Hazard tags
Fire
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Mito Red Light, Super Mobile

Why was it recalled?

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

All Serial/Lot numbers/No UDI

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.

States: Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oregon Pennsylvania Puerto Rico Rhode Island South Carolina Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-2478-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.