Limitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
Limitless Cryo Spa LLC is recalling 219 Glypto Devices and Cryo Machines because they lack FDA 510(k) clearance. The recall covers units distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a lack of 510(k) clearance, which is a regulatory compliance issue rather than a direct physical hazard. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Limitless Cryo Spa LLC is recalling 219 Glypto Devices and Glypto Cryo Machines. The recall is being conducted because the devices lack FDA 510(k) clearance.
The affected units were distributed nationwide. The recall includes all Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by or through Limitless through the August 11, 2026 operational hold, as well as those covered by the August 20, 2026 preliminary field notice.
Consumers who possess these devices should stop using them and contact Limitless Cryo Spa LLC for instructions on how to return or dispose of the product.
The recalled product
- Product
- Glypto Device, Glypto Cryo Machine;
- Manufacturer
- Limitless Cryo Spa LLC
- Category
- Medical Device — Cryotherapy
- Affected units
- 219
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All Glypto units distributed
- placed
- held
- loaned
- inventoried
Distribution
Distributed nationwide across the United States.
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