# FDA recall Z-0153-2023

> **Belmont Instrument Corporation** · Class II · device recall initiated 2021-07-20.

## Product

CritiCool, thermoregulation device

## Reason for recall

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.

## Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

## Key facts

- **Recall number:** Z-0153-2023
- **Recalling firm:** Belmont Instrument Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-20
- **Report date:** 2022-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0153-2023

## Citation

> AI Analytics. FDA recall Z-0153-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0153-2023. Source: US FDA. Licensed CC0.

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