FDA-Device2026-10-14Class IIMISBRANDING
Limitless Cryo Spa Glypto cryo machine recalled for lack of FDA clearance
What this means
Limitless Cryo Spa LLC distributed Glypto cryo machines without obtaining required FDA 510(k) clearance. The devices were supplied to facilities nationwide. No injuries have been reported.
- If you operate or manage a facility with a Glypto device, contact Limitless Cryo Spa LLC for instructions
- Do not use the device until you receive official guidance from the company or FDA
The agency's original wording
Hazard
Lack of 510(k) clearance.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
219
Manufactured in
21 High Ridge Rd, N/A, Ocean, NJ, United States
Products
Glypto Device, Glypto Cryo Machine;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0080-2027Want us to check the next one for you?
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