TemporaryFDAOngoing
Can cause harm that is usually temporary.
Glypto Device, Glypto Cryo Machine;
Check the device or its packaging for
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.
- Why
- Lack of 510(k) clearance.
- Distributed
- US Nationwide distribution.
- Company
- Limitless Cryo Spa LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0080-2027 · retrieved 2 October 2026
Read the official notice