The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

476–500 of 7436

  • 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-2610-2025·2025-10-08

    Reprocessed steerable electrophysiology catheters recalled over residual particulates on surfaces

    Medline is recalling 7,913 reprocessed Livewire Steerable Electrophysiology Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2670-2025·2025-10-08

    Surgical valve pack kits recalled after cannulas may not retain shape

    Medline is recalling 828 VALVE PACK-LF kits because they contain lots of cannula products where the catheter may not retain its shape.

    Product
    Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·H-0002-2026·2025-10-08

    Granola recalled after incorrect label omitted wheat, sesame and cashew allergens

    Whole Foods Market is recalling six one-pound containers of Blueberry Almond Granola sold at a single Philadelphia store because a labeling error left wheat, sesame and cashew undeclared.

    Product
    Whole Foods Market Blueberry Almond Granola, PLU 86032, packaged in a clear plastic container.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-2617-2025·2025-10-08

    Atlan A350XL anesthesia workstations recalled after piston ventilator failures during use

    Draeger is recalling 223 Atlan A350XL anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ve
    Category
    Medical Device
    Distribution
    25 states
  • 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-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-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-2614-2025·2025-10-08

    Reprocessed ultrasound catheters recalled over residual particulates on patient contacting surfaces

    Medline is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2612-2025·2025-10-08

    Reprocessed electrophysiology catheters recalled over residual particulates on patient surfaces

    Medline is recalling 7,913 reprocessed Inquiry Steerable Diagnostic Catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2592-2025·2025-10-08

    Surgical convenience kits recalled after being labeled sterile without sterilization process

    Medline is recalling 22 Major Pack L-F and LB Basic Custom Pack convenience kits that were labeled as sterile but never went through the sterilization process.

    Product
    Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-2616-2025·2025-10-08

    Atlan A350 anesthesia workstations recalled after mechanical ventilation failures were reported

    Draeger is recalling 530 Atlan A350 anesthesia workstations that either indicated a piston ventilator failure before use or suffered a mechanical ventilation failure during use.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
    Category
    Medical Device
    Distribution
    25 states
  • 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-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-2613-2025·2025-10-08

    Reprocessed cardiac imaging catheters recalled over residual particulates on device surfaces

    Medline is recalling 7,913 reprocessed ViewFlex Xtra ICE catheters because specific lots may carry small residual particulates on patient-contacting surfaces.

    Product
    Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
    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
  • 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-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
  • CriticalUSDA FSIS·031-2025·2025-10-04

    Foster Poultry Farms Recalls Chicken Corn Dogs and Ground Turkey Sticks

    Foster Poultry Farms is recalling chicken corn dogs and ground turkey on a stick products due to possible wood contamination. Consumers should not eat these items.

    Product
    Foster Poultry Farms, LLC — Foster Poultry Farms, LLC Recalls Chicken Corn Dog and Ground Turkey on a Stick Products Due To Possible Extraneous Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide