The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

20251–20275 of 32117

  • SevereFDA (Devices)·Z-1648-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1043-2016·2016-05-18

    Bertagni Fresh Sweet Butternut Squash Ravioli Recalled for Undeclared Nuts

    Bertagni 1882 is recalling fresh Sweet Butternut Squash Ravioli because the product may contain undeclared cashew and almond.

    Product
    Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139.
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1616-2016·2016-05-18

    Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk

    Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.

    Product
    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1666-2016·2016-05-18

    Siemens Uric Acid Assays Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1577-2016·2016-05-18

    Medtronic Recalls Capnostream 20 Patient Monitor Battery Packs

    Medtronic is voluntarily recalling battery packs for the Capnostream 20 and 20p patient monitors because they may experience thermal runaway, posing a potential fire risk.

    Product
    Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V318000·2016-05-18

    Heartland Recalls 2016-2017 Trailers Due to Safety Chain Failure Risk

    Heartland is recalling 2016-2017 Fair Field, Lakeview, and Resort trailers because safety chains may break if the main connection fails, increasing crash risk.

    Product
    HEARTLAND — HEARTLAND FAIR FIELD, LAKEVIEW, RESORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1639-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1647-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1635-2016·2016-05-18

    Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage

    Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.

    Product
    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E045000·2016-05-17

    Bendix SR-5 Trailer Spring Brake Valves Recalled for Parking Brake Delay

    Bendix is recalling SR-5 Trailer Spring Brake Valves manufactured between January 2014 and March 2016 because improper machining may delay spring brake application, increasing the risk of trailers rolling away.

    Product
    PARKING BRAKE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V311000·2016-05-17

    BMW Recalls 2011 X5 and X6 Models for Driveshaft Defect

    BMW is recalling 21,493 2011 X5 and X6 vehicles because a front driveshaft joint may fail, increasing crash risk.

    Product
    BMW — BMW X6 ACTIVEHYBRID SAC, X5 DIESEL SAV, X5, X6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V313000·2016-05-17

    Spartan K3 and MM Motorhome Chassis Recalled for Exhaust Fire Risk

    Spartan is recalling 2007-2015 K3 and MM motorhome chassis because a torn flexible exhaust tube may allow hot gas to contact other components, increasing fire risk.

    Product
    SPARTAN — SPARTAN K3, MM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V310000·2016-05-17

    Collins Recalls 2016 School Buses Due to Seat Separation Risk

    Collins Bus Corporation is recalling 2016 DH416 and DE516 school buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    COLLINS — COLLINS DH416, DE516
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V309000·2016-05-17

    Eldorado Transit Bus Recall for Seat Separation Risk

    Eldorado is recalling 2016 Advantage and Aerotech transit buses because seats may separate from the base frame due to bolt failure, increasing injury risk in a crash.

    Product
    ELDORADO — ELDORADO AEROTECH, ADVANTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V312000·2016-05-17

    Kia Recalls 2013 Fortes Due to Front Seatbelt Retainer Defect

    Kia is recalling 2013 Fortes because front seatbelt retractor screws may be loose. This could cause the retractor plate to break in a crash, striking occupants.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V308000·2016-05-17

    Mercedes-Benz Recalls 2016 AMG GT S for Driveshaft Bond Failure

    Mercedes-Benz is recalling 136 model year 2016 AMG GT S vehicles because the carbon-fiber driveshaft bond may fail, causing loss of torque and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V306000·2016-05-16

    Mercedes-Benz Recalls 2016 SLK300 Vehicles for Rear Tie Rod Defect

    Mercedes-Benz is recalling 327 model year 2016 SLK300 vehicles because improperly manufactured lock nuts on the rear wheel tie rods may cause the rear axle to steer independently, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SLK300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V304000·2016-05-16

    Jayco Recalls 2016 Jay Flight SLX Trailers Due to Propane Tank Bolt Defect

    Jayco is recalling 2016 Jay Flight SLX travel trailers because missing lock washers may allow the propane tank to detach, increasing crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V302000·2016-05-16

    Fiat 500 Recall: Manual Transmission Clutch Spring May Fracture

    Chrysler is recalling 2012-2016 Fiat 500 vehicles with manual transmissions because the clutch diaphragm spring may fracture, potentially preventing gear shifting.

    Product
    FIAT — FIAT 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E042000·2016-05-16

    Takata Frontal Passenger Air Bag Inflator Rupture Recall

    Takata is recalling specific frontal passenger air bag inflators that may rupture due to humidity and heat exposure, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E040000·2016-05-13

    ZF Front Axle Recall for Steering Connection Wear Risk

    ZF North America is recalling certain RL 77 and RL 80 EM axle assemblies due to incorrect internal spacers that can cause premature wear in the steering connection.

    Product
    SUSPENSION:FRONT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·027-2016 expansion-3·2016-05-13

    Pilgrim's Pride Recalls Chicken Products Due to Foreign Matter Contamination

    Pilgrim's Pride is expanding a recall of fully cooked chicken products due to possible contamination with extraneous metal materials.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corp. Expands Recall of Poultry Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide