Belmont Instrument Corporation recalls CritiCool thermoregulation devices with serial numbers starting with 99... due to premature pump failure causing HALT 4 error and potential delayed therapy. One death reported.
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.
Take action
Contact the company
📍Recalling firmBelmont Instrument Corporation780 Boston Rd · Billerica, MA 01821-5925
“Belmont CritiCool thermoregulation device recall: Premature pump failure risks delayed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62187-belmont-criticool-thermoregulation-device-recall-premature-pump-failure-risks-delayed. Based on FDA recall #Z-0153-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0153-2023%22&limit=1).
The FDA announced on July 20, 2021, that Belmont Instrument Corporation is recalling the CritiCool thermoregulation device due to premature pump failure. This defect may prevent the device from recovering after displaying a HALT 4 error, potentially delaying prescribed therapy.
How to tell if you have it
Brand: Belmont Instrument
Product: CritiCool, thermoregulation device
UDI-DI: 07290107581110
Serial Numbers: 9978580900011 through 99110698100011 (see full list in record)
The hazard
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.
Context
GovInfoNow's records show other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2026-05-06), Philips Allura Xper FD10F Medical System Recall (2025-12-15), and Baxter Novum IQ Syringe Pump Recall (2026-08-11).
How to tell if you have this one
Check if your CritiCool device has a serial number starting with '99' followed by 12 digits (e.g., 9978580900011). The full list of affected serial numbers is provided in the recall notice.
Brand
Belmont Instrument
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check device status
Look for a HALT 4 error message on the device display. If present, stop using the device immediately.
Contact manufacturer
Reach out to Belmont Instrument Corporation for guidance on next steps if your device shows a HALT 4 error.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. Foreign distribution worldwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0153-2023 (July 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0153-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.