Glypto Device, Glypto Cryo Machine;
Lack of 510(k) clearance.
| Recalling firm | Limitless Cryo Spa LLC |
|---|---|
| Reason | Lack of 510(k) clearance. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Oct 14, 2026 |
| Initiated | Aug 24, 2026 |
| Region | NJ, United States |
| Distribution | US Nationwide distribution. |
| Quantity | 219 |
| Code/Lot | 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/accoun… |
| Type | Voluntary: Firm initiated |
| Recall number | Z-0080-2027 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-0080-2027)
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