Belmont Instrument LLC recalls Allon 2001 devices with part number 200-00263 that may overheat if temperature alarms are disabled and sensors disconnected.
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.
Belmont Instrument LLC is recalling Allon 2001 devices with part number 200-00263. If the temperature alarms are disabled and certain sensors are disconnected, the device may overheat without warning.
The device may overheat if the Human Sensor Board is disconnected from the Controller Board and temperature alarms are disabled, or if the Water In and Water Out sensors are disconnected from the Human Sensor Board and temperature alarms are disabled. This can happen without user notification.
Users of the Allon 2001 device with part number 200-00263 are affected. Those who have the device connected to a patient wrap (ThermoWrap) are at risk if the temperature alarms are disabled.
Check for part number 200-00263 on the device. The recall includes specific serial numbers listed in the record.
Ensure the Human Sensor Board is connected to the Controller Board and temperature alarms are enabled.
Confirm that Water In and Water Out sensors are properly connected to the Human Sensor Board and temperature alarms are enabled.
The part number is 200-00263.
Check if your device has part number 200-00263 and if it matches the listed serial numbers in the recall.
Ensure the Human Sensor Board is connected to the Controller Board and temperature alarms are enabled. Also, confirm Water In and Water Out sensors are connected to the Human Sensor Board and temperature alarms are enabled.
We’ve drafted a message you can send Belmont Instrument to request your refund or repair — edit it as you like.
Subject: Recall Z-1966-2025 — Belmont Instrument Belmont Instrument Hello, I own a Belmont Instrument that is covered by recall Z-1966-2025 from Belmont Instrument. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
