FDA Device recall Z-1966-2025
Allon 2001
- FDA Device
- Class II
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Allon 2001 by Belmont Instrument, citing 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 disconn….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1966-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-13 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Belmont Instrument |
| Distribution | US |
Product
Allon 2001. Part Number: 200-00263
Reason
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.
Identifiers
| code_info | Part Number: 200-00263. UDI-DI: 007290107581103, Serial Numbers: 99111143000002, 99111143000014, 99111627300034, 999390…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, 99111143000009, 99111143000011, 99111143000012, 99111143000013, 99111143000015, 99111143000018, 99111143000019, 99111288700016, 99111288700021, 99111288700035, 99111288700036, 99111627300011, 99111627300017, 99111627300022, 99111627300029, 99111627300040, 99111627300041, 99111627300045, 99111627300046, 99111627300054, 99111627300057, 99111627300064, 99111627300067, 99113168300004, 99113168300005, 99113168300008, 99113168300010, 99113168300012, 99128623400008, 99129614700002, 99129614700005, 99131046400001, 99131046400003, 99131046400004, 99131046400005, 99131046400006, 99131046400009, 99131046400011, 99131046500007, 99132732400009, 99 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1966-2025%22
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