Cryo device Recall: Glypto Unit
FDA recall due to lack of 510(k) clearance for Glypto Device, Glypto Cryo Machine from Limitless Cryo Spa LLC. Approximately 219 units distributed nationwide in the US are affected, with an 08/11/2026 operational hold and a 08/20/2026 preliminary field notice. The recall references a serial/account-specific consignee list and the provided data does not specify any corrective action.
| Brand | Limitless Cryo Spa LLC |
|---|---|
| Product | Glypto Device, Glypto Cryo Machine; |
| Reason | Lack of 510(k) clearance. |
| Severity | moderate |
| Units affected | 219 |
| Distribution | US Nationwide distribution. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Stop using the Glypto device immediately and unplug if safe.
- Contact Limitless Cryo Spa LLC for recall instructions and potential repair or replacement.
- Check whether your unit is listed on the recall list and follow the provided instructions.
- Monitor FDA recall updates for further guidance.
How to identify the recalled item
| Lot / date codes | 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. |
|---|---|
| Lot / date codes | 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. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.