The Recall Desk
HighFDA (Devices)·Z-1966-2025·Announced 2025-06-18

[pending] Allon 2001. Part Number: 200-00263

Pending LLM rewrite. Source: FDA_DEVICE Z-1966-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Allon 2001. Part Number: 200-00263
Manufacturer
Belmont Instrument LLC
Category
Medical Device — Devices

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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