Recall Z-0080-2027 ยท GEH Unit, Cryosurgical, Accessories
Limitless Cryo Spa LLC
Glypto Device, Glypto Cryo Machine;
| Date | Oct 2, 2026 (initiated Aug 24, 2026) |
| Status | Open, Classified |
| Reason | Lack of 510(k) clearance. |
| Root cause | Under Investigation by firm |
| Action | On August 24, 2026, Urgent Medical Device Recall letters were sent to customers. Actions to be taken: 1. Stop using every Glypto device immediately. 2. Unplug the device, clearly mark or tag it as QUARANTINED / DO NOT USE, and secure it in a location where it cannot be used pending removal from your facility or other writte n disposition instructions from Limitless. 3. Do not open, clean, service, repair, modify, move, ship, return, sell, transfer, loan, discard, or destroy any Glypto device or component unless Limitless provides written recall instructions. 4. Complete and return the attached |
| Quantity | 219 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.