Class II — Belmont Instrument Corporation
| Recalling firm | BELMONT INSTRUMENT LLC. |
|---|---|
| Registered facility | BELMONT MEDICAL TECHNOLOGIES (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the prescribed thermoregulation therapy. To date, the firm has received one report of death potentially related to this issue. |
| Product | CritiCool, thermoregulation device |
| Quantity | 158 (US); 803 (OUS) |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Initiated | 2021-07-20 |
| Classified | 2022-10-31 |
| Recall number | Z-0153-2023 |
| 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 Corporation (Z-0153-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90939/
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