CritiCool, thermoregulation device

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 t…

Recall #: Z-0153-2023
Affected scope: 158 (US); 803 (OUS)
Initiated: July 20, 2021

Compiled from official public sources by the publisher. · Updated September 2026

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Belmont Instrument Corporation recalled CritiCool, thermoregulation device - a moderate-severity action.

CritiCool, thermoregulation device was recalled by Belmont Instrument Corporation in November 9, 2022. Reason: Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover…. Check the official notice for the remedy. Verify recall #Z-0153-2023 with the FDA Devices before acting.

The recall

Belmont Instrument Corporation issued this moderate-severity FDA Devices recall-Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover….

Moderate
severity level: Class II
classification: November 9, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0153-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0153-2023
Date reported	November 9, 2022
Date initiated	July 20, 2021
Recalling firm	Belmont Instrument Corporation
Firm location	Billerica, MA
Affected scope	158 (US); 803 (OUS)
Distribution	Domestic distribution nationwide. Foreign distribution worldwide.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0153-2023) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

CritiCool, thermoregulation device. Recalled by Belmont Instrument Corporation. Units affected: 158 (US); 803 (OUS).

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 9, 2022. Severity: Moderate. Recall number: Z-0153-2023.

Where was the recalled product distributed? ▼

Distribution: Domestic distribution nationwide. Foreign distribution worldwide..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Devices, reported November 9, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026