The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1674-2025·Announced 2025-05-07

Hyperthermia Pump Procedure Kit Recalled for Cracked Connector

Belmont Instrument LLC is recalling 158 Hyperthermia Pump Procedure Kits (Model 902-00045) due to a potential crack in the female connector on the Heat Exchanger set that may cause fluid leakage during use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source does not report any actual illnesses, injuries, or adverse events—only a potential safety defect (cracked connector causing fluid leakage). Since there are no reported harms and the hazard is preventable through proper handling, this meets the criteria for Moderate severity.

Plain-English summary

Belmont Instrument LLC is recalling the Hyperthermia Pump Procedure Kit, Model Number 902-00045 (UDI-DI: 00896128002589). The recalled product is a sterile, single-use, disposable kit used with the Hyperthermia Pump and consists of a 4.4 Liter Reservoir, Heat Exchanger set, and HP Procedure Pack. The female quick connector located on the Heat Exchanger set (P/N 902-00006P) may have a crack that causes fluid to leak through the connector during priming of the rapid infuser.

Approximately 158 kits have been distributed nationwide in the following U.S. states: Arizona, California, Colorado, Connecticut, Delaware, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Minnesota, North Carolina, North Dakota, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, and West Virginia. The kits were also distributed internationally to Canada, Hungary, Republic of Korea, Latvia, and Malaysia. The affected lot numbers are 20241005 and 20241108.

Healthcare facilities and users who have this product should stop using the recalled kits immediately and contact Belmont Instrument LLC for instructions regarding the defective units.

The recalled product

Product
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia Procedure kit (P/N 902-00045) consists of 4.4 Liter Reservoir (P/N 902-00034P), Heat Exchanger set (P/N 902-00006P) and HP…
Manufacturer
Belmont Instrument LLC
Category
Medical Device — Hyperthermia / Thermal Procedure Kit
Hazard
Affected units
158

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number: 902-00045. UDI-DI: 00896128002589. Lot Numbers: 20241005
  • 20241108

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Belmont Instrument LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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