- Recalling firm
- Limitless Cryo Spa LLC
- Reason for recall
- Lack of 510(k) clearance.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 219
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Ocean, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0080-2027
- Recall initiated
- August 24, 2026
- FDA classification date
- October 2, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99811
- Last updated on HTM Vibe
- October 21, 2026
