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Z-0080-2027Class II

Limitless Cryo Spa LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Limitless Cryo Spa LLC
Product type
Device
Status
Ongoing
Report date
2026-10-14
Distribution
US Nationwide distribution.
Firm state
NJ
Product quantity
219
Initiated by
Voluntary: Firm initiated
Reason for recall

Lack of 510(k) clearance.

Product description

Glypto Device, Glypto Cryo Machine;

Code / lot info

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.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →