Z-0080-2027

Glypto Device, Glypto Cryo Machine

Name: Z-0080-2027 Glypto Device, Glypto Cryo Machine
Creator: Limitless Cryo Spa LLC
Published: 2026-08-24
License: https://open.fda.gov/license/

Limitless Cryo Spa LLC / initiated 2026-08-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0080-2027
Status: Open, Classified
Initiated: 2026-08-24
Posted: 2026-10-02
Recalling firm: Limitless Cryo Spa LLC
Product: Glypto Device, Glypto Cryo Machine;
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Lack of 510(k) clearance.
FDA 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 Recall Response Form by the response due date above, even if you no longer have the device. 5. Read the serial number or other identifier from the device label/nameplate if present and provide it on the response form. If no label/nameplate is present or it cannot be read, state that on the form and attach clear device photos. 6. Identify the current location and status of each Glypto device and whether it is in your possession, in customer possession, in storage, loaned out, transferred, returned, or no longer available. 7. If you sold, transferred, loaned, placed, or otherwise provided a Glypto device to another person or entity, stop any further distribution and provide Limitless with the downstream recipient's name, telephone number, email, and address. 8. Preserve all Glypto-related records, including purchase, sales, service, repair, training, complaint, adverse-event, refund, text, email, Slack/direct-message, and downstream distribution records. 9. Report any complaint, device problem, injury, medical visit, service/repair issue, workaround, or other safety concern involving a Glypto device to Limitless.
Quantity in commerce: 219
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Product code GEH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-09. View this recall on fda.gov (opens on fda.gov)