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.

17351–17375 of 29208

  • SevereFDA (Food)·F-0230-2017·2016-11-02

    Regalo Bakery Recalls Manju Blackbeans for Undeclared Allergens

    Regalo Bakery is recalling Manju Blackbeans (Hopia Monggo) because the product contains undeclared eggs, wheat, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Manju Blackbeans (Hopia Monggo)" [UPC#78253230917] packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0251-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Egg Salad Due to Listeria Risk

    SM Fish Corp. is recalling 225 units of Ossie's Egg Salad in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S EGG SALAD, NET WT. 7 OZ., UPC 73988570552; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0115-2017·2016-11-02

    St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.

    Product
    Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0235-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox Dairy because FDA environmental sampling found Listeria monocytogenes in the plant.

    Product
    OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0108-2017·2016-11-02

    Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0252-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Egg with Mushroom for Listeria Risk

    SM Fish Corp. is recalling Ossie's Egg with Mushroom due to potential Listeria monocytogenes contamination found during FDA environmental sampling.

    Product
    OSSIE'S EGG WITH MUSHROOM, NET WT. 7 OZ., UPC 73988570556; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0099-2017·2016-11-02

    Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk

    Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0098-2017·2016-11-02

    Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk

    Roche is recalling Modular Pre Analytics EVO/Plus systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0100-2017·2016-11-02

    Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports

    Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by the sharp edge of the sample rack tray.

    Product
    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0245-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Roman Shmaltz Herring Due to Listeria Risk

    SM Fish Corp. is recalling 92 units of Ossie's Roman Shmaltz Herring because FDA environmental sampling found Listeria monocytogenes in the plant.

    Product
    OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·17024·2016-11-02

    Midea Dehumidifiers Recalled Due to Fire and Burn Hazards

    GD Midea is recalling approximately 3.4 million dehumidifiers sold in the U.S. because they can overheat, smoke, and catch fire, posing serious fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0239-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Wasabi Herring Due to Listeria Risk

    SM Fish Corp. is recalling 65 units of Ossie's Wasabi Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0248-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling 82 units of Ossie's Pickled Lox because FDA environmental sampling found Listeria monocytogenes in the facility.

    Product
    OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0095-2017·2016-11-02

    Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas e411 Immunoassay Analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0094-2017·2016-11-02

    Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge

    Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.

    Product
    Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0110-2017·2016-11-02

    Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0106-2017·2016-11-02

    Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury

    Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0237-2017·2016-11-02

    SM Fish Corp. Recalls Herring for Potential Listeria Contamination

    SM Fish Corp. is recalling 106 units of Ossie's Taam Shabbos Herring due to potential Listeria monocytogenes contamination found during FDA environmental sampling.

    Product
    OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0104-2017·2016-11-02

    Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.

    Product
    RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V794000·2016-11-01

    Winnebago Recalls 2017 View and Navion Motorhomes for Seat Bolt Issue

    Winnebago is recalling 2017 View and Navion motorhomes because loose seat mounting bolts may allow seats to detach, increasing injury risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, NAVION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E082000·2016-11-01

    Omix Ada Recalls Replacement Steering Sector Shafts for Early Jeeps

    Omix Ada is recalling 344 replacement steering sector shafts for early Willys and Jeep vehicles due to incomplete heat treatment that may cause premature failure.

    Product
    STEERING:GEAR BOX:SHAFT SECTOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V795000·2016-11-01

    Spartan Motors Recalls Transit Bus Chassis Cabs Due to Exhaust Fire Risk

    Spartan Motors is recalling 245 model year 2011-2017 Transit Bus Chassis Cabs because a disconnecting exhaust tube may expose the floor to high heat, increasing fire risk.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V788000·2016-10-28

    Mazda Recalls 2010-2011 Tribute Vehicles for Fuel Leak Risk

    Mazda is recalling 2010-2011 Tribute vehicles because a cracked fuel delivery module may leak fuel, increasing the risk of fire.

    Product
    MAZDA — MAZDA TRIBUTE, TRIBUTE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide