← FDA ENFORCEMENT
Z-2478-2026Class II

MITO RED LIGHT INC

Recalling firm
MITO RED LIGHT INC
Product type
Device
Status
Ongoing
Report date
2026-06-24
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.
Firm state
AZ
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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.

Product description

Mito Red Light, Super Mobile

Code / lot info

All Serial/Lot numbers/No UDI

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.