Allon 2001 heating device may exceed safe temperature without alarming user
Allon 2001 devices can heat water beyond safe limits when sensors are disconnected and alarms are disabled, risking patient burns without warning. 229 units are affected worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a failure mode that could cause thermal burns from excessive water temperature without alerting the user, though no injuries have been reported.
Plain-English summary
Belmont Instrument LLC is recalling the Allon 2001 medical device (Part Number 200-00263), which includes a patient wrap called ThermoWrap.
An investigation into a report of the ThermoWrap exceeding its set temperature identified a critical failure mode. If the Human Sensor Board is disconnected from the Controller Board and temperature alarms are disabled, or if the Water In, Water Out, and Thermostat sensors are disconnected from the Human Sensor Board and temperature alarms are disabled, the device will continue to heat water above the hardware fault limit. Under these conditions, the device does not alert the user to the faulty condition, creating a risk of thermal injury.
This recall affects 229 units distributed worldwide, including to U.S. states CA, DC, LA, MA, NM, PA, TX, VA, and WA, as well as Belgium, Bolivia, Brazil, Canada, Colombia, Israel, Italy, Portugal, Romania, Sweden, Taiwan, Thailand, and the United Kingdom.
Patients and healthcare providers should ensure temperature alarms are enabled and functioning. Any device suspected of having sensor disconnections or disabled alarms should not be used and the manufacturer should be contacted immediately.
The recalled product
- Product
- Allon 2001. Part Number: 200-00263
- Manufacturer
- Belmont Instrument LLC
- Category
- Medical Device
- Hazard
- burn-injury
- sensor-disconnection
- alarm-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number: 200-00263. UDI-DI: 007290107581103
- Serial Numbers: 99111143000002
- 99111143000014
- 99111627300034
- 9993901600001
- 9993901600002
- 9993901600004
- 9993901600006
- 9993901600007
- 9993901600009
- 9995356300005
- 9995356300006
- 9995356300007
- 9995356300008
- 9996673800002
- 99111143000001
- 99111143000003
- 99111143000004
- 99111143000007
- 99111143000008
Distribution
Distributed nationwide across the United States.
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