Notice names this product. Limitless Cryo Spa’s Glypto Device is named in FDA Class II recall Z-0080-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Lack of 510(k) clearance. Identifying details: 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.. Units affected: 219. Status: Ongoing.
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.
Glypto Device, Glypto Cryo Machine;
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.
Lack of 510(k) clearance.
Company / brand: Limitless Cryo Spa recalls
Affected product: Glypto Device recall status
Official ID Z-0080-2027 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.