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RecallWatchMedical Device Safety
Class IIOngoingZ-1966-2025

Belmont Instrument LLC recalls Allon 2001. Part Number: 200-00263

Belmont Instrument LLCBillerica, MA, United StatesReported Jun 18, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Allon 2001. Part Number:200-00263
    UDI-DI 007290107581103
    228 affected lots
    99111143000002991111430000149911162730003499939016000019993901600002999390160000499939016000069993901600007
    +220 more9993901600009999535630000599953563000069995356300007999535630000899966738000029911114300000199111143000003991111430000049911114300000799111143000008991111430000099911114300001199111143000012991111430000139911114300001599111143000018991111430000199911128870001699111288700021991112887000359911128870003699111627300011991116273000179911162730002299111627300029991116273000409911162730004199111627300045991116273000469911162730005499111627300057991116273000649911162730006799113168300004991131683000059911316830000899113168300010991131683000129912862340000899129614700002991296147000059913104640000199131046400003991310464000049913104640000599131046400006991310464000099913104640001199131046500007991327324000099913273240001899132732400019991342321000119913212100001099113168300003998334980000899914512000029991451200004999217500000199953563000109911162730000199111627300008991131683000139913212100001499132732400005991342321000019913423210000299134232100003991342321000099913423210002299134232100035991116273000429911162730005699111627300058991116273000599911316830001499111627300020991116273000499911316830000699128623400003991321210000139913423210001899914512000019911114300000699111627300005991116273000359911316830000199113168300002991131683000079911162730005399111288700014991112887000179911128870001899111288700019991112887000209911162730001699111627300032991111430000179911114300002199111143000022991112887000019911128870000299129614700009996207670001199132121000012991321210000159913212100000599132121000007991116273000099913423210001799131046400008999535610000399113168300011991116273000259913212100000999111627300061991116273000389974083900001991116273000309991451200006991116273000189976534100006994576770000399833497000089991451200003999145120000999111288700005991116273000319912862340000499128623400005991286234000079912961470000199129614700003991296147000049912961470000799129614700008991310464000029913104650000199131046500002991321210000019912862340000699111143000016996941400000699134232100013991342321000219911162730003699132121000017991321210000189913212100001999132121000020991327324000029913273240000699132732400013991327324000149913423210000599134232100010991321210000169911162730001399111627300033991116273000439911162730004499111627300051991116273000639912961470000699111627300007991116273000249911162730003799111627300047991116273000149911162730005299113168300009991286234000019912862340000299128623400009991286234000109913423210000899111143000020991310464000109913212100001199132732400007991327324000119913273240001299132732400016991342321000349913273240000899132732400015991327324000179913273240002099134232100014995906050001499111627300026991342321000049991451200005999535620000899111143000010991112887000049913104650000399131046500005997353680000799131046500004991310465000089913104650000999132121000004991321210000069913212100000899134232100026991327324000019913273240000399132732400004991342321000079913423210001999405773000059911114300000599111627300048991116273000629913212100000299798415000039913212100000399131046500010

What the firm is doing

Belmont Medical Technologies notified consignees via letter on about 05/13/2025. Consignees were instructed to ensure users of the devices are made aware of the correction, identify affected units on hand and check their serial numbers, ensure all devices have the Temp Sensor Alarms always set to ON to ensure that the user is alerted to errors and conditions requiring actions and attach the provided Step by Step Guide (P/N DDT-063-027) to each device. Consignees were also instructed to complete and return the response form and notify customers if the units were further distributed.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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