Device recall
Glypto Device, Glypto Cryo Machine;
- Recall number
- Z-0080-2027
- Event id
- 99811
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Limitless Cryo Spa LLC
- Report date
- Oct 14, 2026
- Posted
- Oct 2, 2026
- Initiated
- Aug 24, 2026
- Center classification date
- Oct 2, 2026
- Product code
- GEH
- Device type
- Unit, Cryosurgical, Accessories
- Reason
- Lack of 510(k) clearance.
- Root cause
- Under Investigation by firm
- Quantity
- 219
- Code info
- 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.
- Distribution
- US Nationwide distribution.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Ocean, NJ, United States