Belmont Instrument LLC: Medical Device Recall in 2025 - (Recall #: Z-1674-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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 Procedure Pack (P/N 902-00048P). The three components are packaged separately in individual pouches and boxes and placed in the same case for shipment. All three components are connected prior to use. The female quick connector that may be cracked is located on the Heat Exchanger set (P/N 902-00006P).

Product Classification:

Class II

Date Initiated: March 31, 2025

Date Posted: May 7, 2025

Recall Number: Z-1674-2025

Event ID: 96617

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 158 sets

Code Information:

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

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, IL, IN, KS, KY, MA, ME, MN, NC, ND, NJ, NM, OH, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hungary, Korea (the Republic of), Latvia, Malaysia.

Voluntary or Mandated:

Voluntary: Firm initiated