Belmont Instrument recalls

5 official recalls and safety alerts involving Belmont Instrument since 2022-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Belmont Instrument or the relevant agency.

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

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

    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…

    FDA · DeviceBelmont Instrument LLCWorldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM,…Official notice →
  3. 2025-05-07
  4. US
    Drugs & medicalClass II

    Belmont Instrument LLC recalls 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018)…

    Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

    FDA · DeviceBelmont Instrument LLCNationwide distribution to AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, LA, MA,…Official notice →
  5. US
    Drugs & medicalClass II

    Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The…

    Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of the rapid infuser.

    FDA · DeviceBelmont Instrument LLCWorldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC,…Official notice →
  6. 2025-02-12
  7. US
    Drugs & medicalClass II

    Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or…

    Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

    FDA · DeviceBelmont Instrument LLCWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
  8. 2022-11-09
  9. US
    Drugs & medicalClass II

    Belmont Instrument Corporation recalls CritiCool, thermoregulation device

    Premature pump failure may lead to the device displaying a HALT 4 error, from which the device cannot recover even after device reboot. The issue may potentially lead to delayed treatment and a failure to deliver the…

    FDA · DeviceBelmont Instrument CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice →