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…
Read the official notice →- Date
- 2025-06-18
- Country
- United States
- Brand
- Belmont Instrument
- Product
- Allon 2001. Part Number: 200-00263
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, DC, LA, MA, NM,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Belmont Instrument recalls
- 2025-05-07
USBelmont 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.
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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 → - 2025-02-12
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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 → - 2022-11-09
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Belmont Instrument Corporation recalls CritiCool, thermoregulation device
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FDA · DeviceBelmont Instrument CorporationDomestic distribution nationwide. Foreign distribution worldwide.Official notice →
Other drugs & medical recalls in the United States
- 2025-06-18
- US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7)…
A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-69 (Fix)
A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
FDA · DeviceTurncare, IncUS Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…Official notice → - US
Turncare, Inc recalls Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.
FDA · DeviceTurncare, IncUS Nationwide distribution in the states of Texas, Illinois, Pennsylvania,…Official notice → - US
Mobius Mobility LLC recalls iBOT PMD with software version 01.05.24. Personal Mobility Device.
Software issue that could potentially lead to the device tipping over from Balance Mode.
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Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove…
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Microtek Medical, Inc. recalls Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm…
Due to non-sterile products being labeled as sterile
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