Glypto Device, Glypto Cryo Machine;

Lack of 510(k) clearance.

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.