FDA Class II · Medical device · October 14, 2026
Glypto Device recall — Limitless Cryo Spa LLC
Lack of 510(k) clearance.
Official ID Z-0080-2027 · Official record ↗
Recall found. Limitless Cryo Spa is named in FDA Class II recall Z-0080-2027 covering Glypto Device. 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.. Status: Ongoing.
Lack of 510(k) clearance.
Official ID Z-0080-2027 · Official record ↗
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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.