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Recall Observatory FDA recall evidence

Device product

Mito Red Light, Super Mobile

Z-2478-2026

February 12, 2025

Class II

Product summary

Firm
MITO RED LIGHT INC
Event
Event 98999
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2478-2026

Official wording

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

Code information: All Serial/Lot numbers/No UDI

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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