FDAClass II · Medical device · Recall Z-2478-2026 · Recalled June 24, 2026

Mito Red Light recall — MITO RED LIGHT INC

Agency report date: June 24, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Mito Red Light
Company / brand: MITO RED LIGHT
Lot / serial / date codes: 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.

Agency product description and boundaries

Mito Red Light, Super Mobile

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

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

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Mito Red Light recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2478-2026
Brand: All MITO RED LIGHT recalls
Classification: Class II
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Mito Red Light recall status

Companies & origin

Recalling firm location: Scottsdale, AZ, United States
Firm address: 9319 N 94th Way Ste 400, 85258-5565

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Firm notified the public via: E-Mail
FDA event ID: 98999
Recall initiated: February 12, 2025
FDA classified: June 17, 2026
FDA report date: June 24, 2026

Other medical device recalls from around the same time

Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Medline Convenience Kits recall — Medline Industries, LPFDA · July 1, 2026
Impella CP Set with SmartAssist recall — Abiomed, Inc.FDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026
Description/REF recall — ARROW INTERNATIONAL, LLCFDA · June 24, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 22, 2026 at 6:00 PM UTC.

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