RegWardenFDA facility compliance records
Company

BELMONT INSTRUMENT LLC.

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2012: 1 recalls; 2021: 1 recalls; 2025: 4 recalls1’12’13’14’15’16’17’18’19’201’21’22’23’244’25’26
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-05-13
    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. …
  • Class IIOngoing2025-03-31
    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.
  • Class IIOngoing2025-03-31
    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.
  • Class IIOngoing2025-01-02
    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
  • Class IIOngoing2021-07-20
    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 prescribed thermoregulation therapy. To date, the firm has rece…
  • Class IITerminated2012-09-25
    Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry area.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “BELMONT INSTRUMENT LLC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1219702-belmont-instrument-llc/

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