Class IIOngoingZ-2551-2025
Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Boston Scientific Corp…MNSep 17, 2025
Recalls in Minnesota
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 97–108 of 233 recalls
Class IIOngoingZ-2550-2025
Boston Scientific Corporation recalls ICEfx Cryoablation System
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2536-2025
Boston Scientific Corporation recalls Boston Scientific UroMax Ultra Kit
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2535-2025
Boston Scientific Corporation recalls Boston Scientific NephroMax Kit
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2534-2025
Boston Scientific Corporation recalls Boston Scientific Encore Advantage Kit
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2533-2025
Boston Scientific Corporation recalls Boston Scientific Encore 26 Inflation Device
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon.…
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2527-2025
ICU Medical Inc. recalls Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector wit…
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025
Class IIOngoingZ-2526-2025
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with flow stop
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025
Class IIOngoingZ-2525-2025
ICU Medical Inc. recalls Smiths Medical CADD" Medication Cassette Reservoir with flow stop
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025
Class IIOngoingZ-2524-2025
ICU Medical Inc. recalls Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025
Class IIOngoingZ-2523-2025
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vente…
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025
Class IIOngoingZ-2522-2025
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvente…
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
ICU Medical Inc.MNSep 10, 2025