Allon 2001 — Class II medical device recall Z-1966-2025
Ongoing recall by Belmont Instrument LLC, reported 2025-06-18, distributed nationwide. An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set
| Recall number | Z-1966-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Belmont Instrument LLC, Billerica, MA, United States |
| Recall initiated | 2025-05-13 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BO, BR, CA, CN, CO, GB, IL, IT, PT, RO, SE, TH, TW |
| Quantity | 229 units |
| UPC / GTIN / UDI-DI | 09962076700011, 09974083900001, 09991451200006, 09995356100003, 09995356300007, 99111143000001, 99111143000018, 99111288700002, 99111288700019, 99111627300009, 99111627300016, 99111627300030, 99111627300047, 99111627300054, 99111627300061, 99113168300005, 99113168300012, 99128623400008, 99129614700008, 99131046400005, 99131046500002, 99132121000004, 99132121000011, 99132732400002, 99132732400019 and 1 more |
| Serial numbers | 99111143000001, 99111143000002, 99111143000003, 99111143000004, 99111143000005, 99111143000006, 99111143000007, 99111143000008, 99111143000009, 99111143000010, 99111143000011, 99111143000012, 99111143000013, 99111143000014, 99111143000015, 99111143000016, 99111143000017, 99111143000018, 99111143000019, 99111143000020, 99111143000021, 99111143000022, 99111288700001, 99111288700002, 99111288700004 and 203 more |
| Model numbers | 200-00263 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1966-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.