Glypto Device recall (Limitless Cryo Spa LLC)
Medical deviceClass IIOngoing
Summary: Limitless Cryo Spa LLC is recalling Glypto Device, Glypto Cryo Machine;. Reason: Lack of 510(k) clearance.
What is being recalled
Glypto Device, Glypto Cryo Machine;
Why
Lack of 510(k) clearance.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0080-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 24, 2026 |
| Reported | October 14, 2026 |
| Company | Limitless Cryo Spa LLC |
| Company location | Ocean, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 219 |
More recalls from Limitless Cryo Spa LLC · all medical device recalls · recalls from August 2026