# FDA recall Z-1966-2025

> **Belmont Instrument LLC** · Class II · device recall initiated 2025-05-13.

## Product

Allon 2001. Part Number: 200-00263

## Reason for recall

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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1966-2025
- **Recalling firm:** Belmont Instrument LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-13
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Billerica, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1966-2025

## Citation

> AI Analytics. FDA recall Z-1966-2025. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1966-2025. Source: US FDA. Licensed CC0.

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