Belmont Instrument LLC recalls Allon 2001. Part Number: 200-00263

Recall date

May 13, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1966-2025

FDA classification

Class II

Brand / firm

Belmont Instrument LLC

Sold / distributed

Worldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM, PA, TX, VA, WA and the countries of Belgium, Bolivia (Plurinational State of), Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan (Province of China), Thailand, United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Allon 2001. Part Number: 200-00263