Drug & Device Safety Atlas

FDA recall record · openFDA

Belmont Instrument LLC

6 FDA recalls on record (2025) — 6 device. 6 still ongoing.

0
Class I (most serious)
6
Class II
0
Class III
6
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Potential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak throug 3
Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak 1
An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperatu 1
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may l 1

Recalls

3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Rese Class II 2025-03-31 Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperth Class II 2025-03-31 Allon 2001. Part Number: 200-00263 Class II 2025-05-13 Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operatio Class II 2025-01-02 Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile, single-use, disposable set used with th Class II 2025-03-31 Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile, single-use, disposable set used with Class II 2025-03-31

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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