FDAClass II · Medical device · Recall Z-0080-2027 · Recalled October 14, 2026

Glypto Device recall — Limitless Cryo Spa LLC

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Glypto Device
Company / brand: Limitless Cryo Spa
Lot / serial / date codes: 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.

Agency product description and boundaries

Glypto Device, Glypto Cryo Machine;

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Lack of 510(k) clearance.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Glypto Device recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-0080-2027
Brand: All Limitless Cryo Spa recalls
Classification: Class II
Units affected: 219
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Glypto Device recall status

Companies & origin

Recalling firm location: Ocean, NJ, United States
Firm address: 21 High Ridge Rd, N/A, 07712-3460

Identifying details (verbatim from the notice)

Product codes / 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.
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 99811
Recall initiated: August 24, 2026
FDA classified: October 2, 2026
FDA report date: October 14, 2026

Other medical device recalls from around the same time

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Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall — Boston Scientific CorporationFDA · September 30, 2026
Halyard IV START KIT NON-STERILE recall — AVID Medical, Inc.FDA · September 30, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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