Recall archive / FDA device enforcement

Allon 2001. Part Number: 200-00263 — FDA record Z-1966-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class II
Recalling firm: Belmont Instrument LLC
Quantity: 229 units
Agency-reported status: Ongoing
Source record identifier: Z-1966-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 99132732400018, 99132732400019, 99134232100011, 99132121000010, 99113168300003, 9983349800008, 9991451200002, 9991451200004, 9992175000001, 9995356300010, 99111627300001, 99111627300008, 99113168300013, 99132121000014, 99132732400005, 99134232100001, 99134232100002, 99134232100003, 99134232100009, 99134232100022, 99134232100035, 99111627300042, 99111627300056, 99111627300058, 99111627300059, 99113168300014, 99111627300020, 99111627300049, 99113168300006, 99128623400003, 99132121000013, 99134232100018, 9991451200001, 99111143000006, 99111627300005, 99111627300035, 99113168300001, 99113168300002, 99113168300007, 99111627300053, 99111288700014, 99111288700017, 99111288700018, 99111288700019, 99111288700020, 99111627300016, 99111627300032, 99111143000017, 99111143000021, 99111143000022, 99111288700001, 99111288700002, 99129614700009, 9962076700011, 99132121000012, 99132121000015, 99132121000005, 99132121000007, 99111627300009, 99134232100017, 99131046400008, 9995356100003, 99113168300011, 99111627300025, 99132121000009, 99111627300061, 99111627300038, 9974083900001, 99111627300030, 9991451200006, 99111627300018, 9976534100006, 9945767700003, 9983349700008, 9991451200003, 9991451200009, 99111288700005, 99111627300031, 99128623400004, 99128623400005, 99128623400007, 99129614700001, 99129614700003, 99129614700004, 99129614700007, 99129614700008, 99131046400002, 99131046500001, 99131046500002, 99132121000001, 99128623400006, 99111143000016, 9969414000006, 99134232100013, 99134232100021, 99111627300036, 99132121000017, 99132121000018, 99132121000019, 99132121000020, 99132732400002, 99132732400006, 99132732400013, 99132732400014, 99134232100005, 99134232100010, 99132121000016, 99111627300013, 99111627300033, 99111627300043, 99111627300044, 99111627300051, 99111627300063, 99129614700006, 99111627300007, 99111627300024, 99111627300037, 99111627300047, 99111627300014, 99111627300052, 99113168300009, 99128623400001, 99128623400002, 99128623400009, 99128623400010, 99134232100008, 99111143000020, 99131046400010, 99132121000011, 99132732400007, 99132732400011, 99132732400012, 99132732400016, 99134232100034, 99132732400008, 99132732400015, 99132732400017, 99132732400020, 99134232100014, 9959060500014, 99111627300026, 99134232100004, ", 99134232100006", 9991451200005, 9995356200008, 99111143000010, 99111288700004, 99131046500003, 99131046500005, 9973536800007, 99131046500004, 99131046500008, 99131046500009, 99132121000004, 99132121000006, 99132121000008, 99134232100026, 99132732400001, 99132732400003, 99132732400004, 99134232100007, 99134232100019, 9940577300005, 99111143000005, 99111627300048, 99111627300062, 99132121000002, 9979841500003, 99132121000003, 99131046500010

Label field

Details supplied by the agency

Lot, code or applicability

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, 99132732400018, 99132732400019, 99134232100011, 99132121000010, 99113168300003, 9983349800008, 9991451200002, 9991451200004, 9992175000001, 9995356300010, 99111627300001, 99111627300008, 99113168300013, 99132121000014, 99132732400005, 99134232100001, 99134232100002, 99134232100003, 99134232100009, 99134232100022, 99134232100035, 99111627300042, 99111627300056, 99111627300058, 99111627300059, 99113168300014, 99111627300020, 99111627300049, 99113168300006, 99128623400003, 99132121000013, 99134232100018, 9991451200001, 99111143000006, 99111627300005, 99111627300035, 99113168300001, 99113168300002, 99113168300007, 99111627300053, 99111288700014, 99111288700017, 99111288700018, 99111288700019, 99111288700020, 99111627300016, 99111627300032, 99111143000017, 99111143000021, 99111143000022, 99111288700001, 99111288700002, 99129614700009, 9962076700011, 99132121000012, 99132121000015, 99132121000005, 99132121000007, 99111627300009, 99134232100017, 99131046400008, 9995356100003, 99113168300011, 99111627300025, 99132121000009, 99111627300061, 99111627300038, 9974083900001, 99111627300030, 9991451200006, 99111627300018, 9976534100006, 9945767700003, 9983349700008, 9991451200003, 9991451200009, 99111288700005, 99111627300031, 99128623400004, 99128623400005, 99128623400007, 99129614700001, 99129614700003, 99129614700004, 99129614700007, 99129614700008, 99131046400002, 99131046500001, 99131046500002, 99132121000001, 99128623400006, 99111143000016, 9969414000006, 99134232100013, 99134232100021, 99111627300036, 99132121000017, 99132121000018, 99132121000019, 99132121000020, 99132732400002, 99132732400006, 99132732400013, 99132732400014, 99134232100005, 99134232100010, 99132121000016, 99111627300013, 99111627300033, 99111627300043, 99111627300044, 99111627300051, 99111627300063, 99129614700006, 99111627300007, 99111627300024, 99111627300037, 99111627300047, 99111627300014, 99111627300052, 99113168300009, 99128623400001, 99128623400002, 99128623400009, 99128623400010, 99134232100008, 99111143000020, 99131046400010, 99132121000011, 99132732400007, 99132732400011, 99132732400012, 99132732400016, 99134232100034, 99132732400008, 99132732400015, 99132732400017, 99132732400020, 99134232100014, 9959060500014, 99111627300026, 99134232100004, ", 99134232100006", 9991451200005, 9995356200008, 99111143000010, 99111288700004, 99131046500003, 99131046500005, 9973536800007, 99131046500004, 99131046500008, 99131046500009, 99132121000004, 99132121000006, 99132121000008, 99134232100026, 99132732400001, 99132732400003, 99132732400004, 99134232100007, 99134232100019, 9940577300005, 99111143000005, 99111627300048, 99111627300062, 99132121000002, 9979841500003, 99132121000003, 99131046500010

Match all identifying details in the current notice. A brand name alone is not enough.

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 18, 2025
Recall initiation date: May 13, 2025
Center classification date: Jun 12, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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