OVERLOOKED

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Class IIOngoing

Limitless Cryo Spa LLC recalls Glypto Device

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Limitless Cryo Spa LLC
Reason
Lack of 510(k) clearance.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99811…

Products

  1. Glypto Device, Glypto Cryo Machine;

    Codes/lots: All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented.Quantity: 219Recall no. Z-0080-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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