Belmont Instrument LLC: Medical Device Recall in 2025 - (Recall #: Z-1099-2025)

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:

Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006

Product Classification:

Class II

Date Initiated: January 2, 2025

Date Posted: February 12, 2025

Recall Number: Z-1099-2025

Event ID: 96092

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,029 cases (12,348 sets)

Code Information:

UDI-DI: 00896128002022 Lot Numbers: 20240910, 20241002, 20241006, 20241014

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Japan, Malaysia, Poland, Switzerland, Taiwan (Province of China), Ukraine.

Voluntary or Mandated:

Voluntary: Firm initiated