FDA-Device2025-06-18Class II
Allon 2001. Part Number: 200-00263
Belmont Instrument LLC
Hazard
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.
Sold states
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.
Affected count
229 units
Manufactured in
780 Boston Rd, Billerica, MA, United States
Products
Allon 2001. Part Number: 200-00263
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1966-2025Don't want to check this manually?
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