Official recall notice

FDA DeviceClass IINotable

Glypto Device Glypto Cryo Machine Recall (Oct 2026)

Product: Glypto Device, Glypto Cryo Machine;

Recall date
2026-10-14
FDA class
Class II

Why it was recalled

Hazard

Lack of 510(k) clearance.

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Lack of 510(k) clearance.

Affected products

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.

Verify with the official notice →
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