The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

9576–9600 of 29157

  • SevereFDA (Devices)·Z-2255-2020·2020-06-10

    FDA Recalls Multifire Endo Hernia Staplers Due to Assembly Error

    The FDA is recalling 12,610 Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2233-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2210-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0972-2020·2020-06-10

    K F K Seasonings Recalls Azure Market Chili Powder for Undeclared Allergens

    K F K Seasonings LLC is recalling 96 lbs of Azure Market Chili Powder, Mild, Organic due to undeclared tree nuts and Crustacea.

    Product
    Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold under brand Azure Market. This product contains "Organic Chili Peppers, Salt, Organic Spices, Organic Garlic, Organic Sunflower Oil". The Azure Market label listed the lot # 90030041520 and U
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0985-2020·2020-06-10

    Sienna Cranberry Orange Muffins Recalled for Undeclared Walnuts

    BAKE'N JOY FOODS, INC. is recalling Sienna brand Cranberry Orange Muffins because they may contain undeclared walnuts.

    Product
    Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31B
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0973-2020·2020-06-10

    K F K Seasonings Recalls Organic Chipotle Chile Ground for Undeclared Tree Nuts

    K F K Seasonings is recalling 230 lbs of Organic Chipotle Chile Ground sold as Blue Chip in Oregon and Utah due to undeclared tree nuts.

    Product
    Organic Chipotle Chile Ground, Item # 90033. Packaged in 40 lbs. box and sold under brand Blue Chip. This product contains Chipotle Chile pepper. The Blue Chip label listed the lot # 032918. No UPC. Product distributed by Blue Chip Corp. UT.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·20V341000·2020-06-10

    KME Fire Trucks Recalled for Potential Braking Mechanism Separation

    KME is recalling specific fire trucks because the optional Telma induction braking mechanism may separate from the vehicle while moving, increasing crash risk.

    Product
    KME — KME PREDATOR, PREDATOR PANTHER, PREDATOR SS, COMMERCIALCAB/ CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2257-2020·2020-06-10

    Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification

    Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.

    Product
    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2205-2020·2020-06-10

    Umano Medical Recalls AC Powered Hospital Adjustable Beds

    Umano Medical is recalling 3,259 AC powered hospital adjustable beds due to a potential hazard of unsupervised patients falling out of bed.

    Product
    AC Powered hospital adjustable bed.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2261-2020·2020-06-10

    Spacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure

    Spacelabs Healthcare is recalling Xhibit Central software due to reports of audio alarm loss after power failures or cable disconnections, which could delay alarm recognition.

    Product
    Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2165-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet Corporation is recalling 1,773 Omnipod DASH Insulin Management Systems (mmol/L configuration) because the Bolus Calculator may fail to accurately subtract insulin on board after two months of use.

    Product
    Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2231-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2020·2020-06-10

    Multifire Endo Hernia Stapler Recalled for Manufacturing Assembly Error

    Covidien is recalling Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly during use.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2207-2020·2020-06-10

    Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling

    Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.

    Product
    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-2229-2020·2020-06-10

    FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2174-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2258-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-2211-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2219-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indica
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V337000·2020-06-09

    Jayco Recalls 2020 Motorized RVs Due to Window Glass Detachment Risk

    Jayco is recalling 2020 motorized recreational vehicles because the adhesive on frameless windows may fail, allowing glass to detach and become a projectile.

    Product
    JAYCO — JAYCO, ENTEGRA REDHAWK, QWEST, SENECA, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V335000·2020-06-09

    ARBOC Spirit of America and Liberty Buses Recalled for Fire Risk

    ARBOC is recalling 113 Spirit of America and Spirit of Liberty buses because misrouted power cables may short circuit, increasing the risk of a fire.

    Product
    ARBOC — ARBOC SPIRIT OF AMERICA, SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V334000·2020-06-09

    Chrysler Recalls 2017-2020 Pacifica Plug-in Hybrids for Fire Risk

    Chrysler is recalling 2017-2020 Pacifica Plug-in Hybrids because a high-resistance electrical connection may overheat and cause a fire.

    Product
    CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide