Class II — Belmont Instrument LLC
| Recalling firm | BELMONT INSTRUMENT LLC. |
|---|---|
| Registered facility | BELMONT MEDICAL TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition. |
| Product | Allon 2001. Part Number: 200-00263 |
| Quantity | 229 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM, PA, TX, VA, WA and the countries of Belgium, Bolivia (Plurinational State of), Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan (Province of China), Thailand, United Kingdom. |
| Initiated | 2025-05-13 |
| Classified | 2025-06-12 |
| Recall number | Z-1966-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Belmont Instrument LLC (Z-1966-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96854/
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