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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96854

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 13, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Belmont Instrument LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Allon 2001. Part Number: 200-00263

Z-1966-2025
Recall number
Z-1966-2025
Initiated
May 13, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Belmont Instrument LLC
Quantity
229 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.