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Belmont Instrument Recalls
8 recalls on record · October 24, 2012 to June 18, 2025 · Medical Devices
Recalls by year
12
22
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 18, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Allon 2001. Part Number: 200-00263
Hazard: 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.
May 7, 2025Medical DevicesFDA
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 Rese
Hazard: 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.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with
Hazard: 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.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with th
Hazard: 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.
May 7, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth
Hazard: 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.
February 12, 2025Medical DevicesFDA
Belmont Instrument LLC recalls Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operatio
Hazard: 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
November 9, 2022Medical DevicesFDA
Belmont Instrument Corporation recalls CritiCool, thermoregulation device
Hazard: 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 received one report of death potentially related to this issue.
October 24, 2012Medical DevicesFDA
Belmont Instrument Corporation recalls Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
Hazard: 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.