The Recall Desk

Hazard

Helium Leak recalls

19 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
19
Critical
15
Severe
0
Most recent
2025-10-08

Of the 19 helium leak recalls we have scored against our rubric, 15 (79%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all helium leak recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–19 of 19

  • CriticalFDA (Devices)·Z-2662-2025·2025-10-08

    MAGNETOM Skyra Fit BioMatrix systems recalled over magnet vent ice blockage

    Siemens is recalling 39 MAGNETOM Skyra Fit BioMatrix systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2661-2025·2025-10-08

    MAGNETOM Skyra fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 56 MAGNETOM Skyra fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Skyra fit. Model Number: 10849580.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2656-2025·2025-10-08

    MAGNETOM Cima.X systems recalled over ice blockage in helium venting system

    Siemens is recalling 22 MAGNETOM Cima.X (DE) systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Cima.X (DE). Model Number: 11647158.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2665-2025·2025-10-08

    MAGNETOM Verio Dot systems recalled over magnet venting ice blockage risk

    Siemens is recalling 59 MAGNETOM Verio Dot systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot. Model Number: 10684333.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2668-2025·2025-10-08

    MAGNETOM Vida Fit MRI systems recalled over magnet vent ice blockage

    Siemens is recalling 41 MAGNETOM Vida Fit MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Vida Fit. Model Number: 11410481.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2654-2025·2025-10-08

    Biograph mMR scanners recalled over ice blockage in magnet venting

    Siemens is recalling 27 Biograph mMR systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    Biograph mMR. Model Number: 10433372.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2657-2025·2025-10-08

    MRI scanner recalled over ice blockage in magnet helium venting system

    A MAGNETOM Connectom.X MRI system is being recalled because an ice blockage in the magnet venting system could prevent helium from escaping during a quench.

    Product
    MAGNETOM Connectom.X. Model Number: 11371480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2664-2025·2025-10-08

    MAGNETOM Verio MRI systems recalled over magnet venting ice blockage risk

    Siemens is recalling 154 MAGNETOM Verio MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio. Model Number: 10276755.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2658-2025·2025-10-08

    MAGNETOM Lumina MRI systems recalled over helium venting ice blockage risk

    Siemens is recalling 130 MAGNETOM Lumina (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Lumina (DE). Model Number: 11344916.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2659-2025·2025-10-08

    MAGNETOM Prisma MRI systems recalled over helium venting ice blockage

    Siemens is recalling 101 MAGNETOM Prisma MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Prisma. Model Number: 10849582.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2667-2025·2025-10-08

    MAGNETOM Vida MRI systems recalled over ice blockage in magnet venting

    Siemens is recalling 498 MAGNETOM Vida (DE) MRI systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2660-2025·2025-10-08

    MAGNETOM Skyra MRI systems recalled over ice blockage in venting system

    Siemens is recalling 586 MAGNETOM Skyra (DE) MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2663-2025·2025-10-08

    MAGNETOM Spectra MRI systems recalled over helium venting ice blockage

    Siemens is recalling three MAGNETOM Spectra MRI systems because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2666-2025·2025-10-08

    MAGNETOM Verio Dot Upgrade systems recalled over magnet venting ice blockage

    Siemens is recalling 78 MAGNETOM Verio Dot Upgrade systems because an ice blockage in the magnet venting system could stop helium escaping during a quench.

    Product
    MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2655-2025·2025-10-08

    BIOGRAPH One scanner recalled over ice blockage in magnet venting system

    Siemens is recalling one BIOGRAPH One (DE) system because an ice blockage in the magnet venting system could prevent helium escaping during a quench.

    Product
    BIOGRAPH One (DE). Model Number: 11689172.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2023·2023-03-15

    Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

    Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

    Product
    Cardiosave Rescue. Model Number: 0998-00-0800-83.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2023·2023-03-15

    Cardiosave intra-aortic balloon pump O-ring defects may interrupt therapy

    Damaged or worn O-rings on the Cardiosave pump console quick disconnect fitting can leak helium, potentially interrupting cardiac support therapy for affected patients.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide