Class IIOngoingZ-2231-2025
3M Company recalls 3M Ranger Irrigation Fluid Warming Set
Notice was issued to clarify flow rates related to the inlet fluid temperature.
- Infusion Fluid Thermal Warmer
- Device Design
3M CompanyMNAug 6, 2025
Infusion Fluid Thermal Warmer recalls
The FDA has posted 5 enforcement recalls of infusion fluid thermal warmer devices since 2025, none of them Class I (most serious). Most recent report: Aug 6, 2025.
Class II: 5
Who is recalling these devices
Latest recalls
View all 5 in the recall browser →Class IIOngoingZ-1678-2025
Belmont Instrument LLC recalls 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-0003…
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.
- Infusion Fluid Thermal Warmer
- Process design
Belmont Instrument LLCMAMay 7, 2025
Class IIOngoingZ-1674-2025
Belmont Instrument LLC recalls Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile
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.
- Infusion Fluid Thermal Warmer
- Process design
Belmont Instrument LLCMAMay 7, 2025
Class IIOngoingZ-1675-2025
Belmont Instrument LLC recalls Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile
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.
- Infusion Fluid Thermal Warmer
- Process design
Belmont Instrument LLCMAMay 7, 2025
Class IIOngoingZ-1676-2025
Belmont Instrument LLC recalls Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile
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.
- Infusion Fluid Thermal Warmer
- Process design
Belmont Instrument LLCMAMay 7, 2025
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Warmer, Thermal, Infusion Fluid”). Informational only — verify against the FDA before acting.