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.

17326–17350 of 29206

  • SevereNHTSA·16V802000·2016-11-04

    GM Recalls 2017 Cadillac XT5 and GMC Acadia for Brake Caliper Defect

    General Motors is recalling 2017 Cadillac XT5 and GMC Acadia vehicles because front brake caliper seals may leak fluid, reducing braking performance.

    Product
    CADILLAC — CADILLAC, GMC XT5, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V804000·2016-11-04

    PTIC Recalls Stratos Asphalt Distributor Trailers Due to Axle Overload Risk

    PTIC is recalling 2014-2016 Stratos asphalt distributor trailers because fully loaded weight may exceed axle capacity, risking bearing overheating or hub detachment.

    Product
    STRATOS — STRATOS DMD-1000, DMT-1000, DMD-600, DMD-400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V803000·2016-11-04

    PACCAR Recalls 2017 Peterbilt and Kenworth Trucks for Tire Defect

    PACCAR is recalling 2017 Peterbilt and Kenworth trucks equipped with specific Goodyear tires that may partially separate, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 389, 337, 330, T660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·102-2016·2016-11-03

    Flavor Trade Recalls Beef Jerky Produced Without Federal Inspection

    Flavor Trade, LLC. is recalling approximately 113 pounds of beef jerky produced without federal inspection and bearing unauthorized USDA marks.

    Product
    Flavor Trade, LLC. Recalls Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0097-2017·2016-11-02

    Roche Recalls cobas 8000 Analyzers Due to Sharp Edge Injury Reports

    Roche is recalling cobas 8000 Modular Analyzers and e602 Immunoassay Analyzers after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas 8000 Modular Analyzer Series c8000, Chemistry (Photometric, Discrete) for clinical use Modular e602: Immunoassay Analyzer Product Usage: The VS II system is a stand-alone, computer-controlled instrument designed to aliquot patient sample from a primary tube to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls enGen Laboratory Automation System Due to Sample Error

    Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.

    Product
    enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Version 3.6.1 and Below; IVD. --- Thermo Scientific Centrifuge Module has Product Code 952040-EG 6844097. The VITROS 5,1 FS Chemistry System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0246-2017·2016-11-02

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

    SM Fish Corp. is recalling 167 units of Ossie's Pickled Herring in New York and New Jersey due to potential Listeria monocytogenes contamination found in the plant.

    Product
    OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0109-2017·2016-11-02

    Roche Recalls cobas p 312 Pre-Analytical System Calculator Modules

    Roche is recalling 9,014 cobas p 312 Pre-Analytical System calculator/data processing modules due to four reported injuries caused by a sharp edge on the sample rack tray.

    Product
    cobas p 312 Pre-Analytical System calculator/data processing module, for clinical use Product Usage: The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0101-2017·2016-11-02

    Roche Recalls cobas p 701 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 701 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The URISYS 2400 Analyzer is a fully automated urinalysis system intended for in vitro qualitative or semi-quantitative determination of urine analytes, including pH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0107-2017·2016-11-02

    Roche Recalls cobas p 512 Pre-Analytical Instrument Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 cobas p 512 Pre-Analytical Instruments after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems support an automated and integrated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) to be applied in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0105-2017·2016-11-02

    Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports

    Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.

    Product
    RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0102-2017·2016-11-02

    Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges

    Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0229-2017·2016-11-02

    Regalo Bakery Recalls Spanish Rolls for Undeclared Allergens

    Regalo Bakery is recalling Spanish Rolls because the product contains undeclared eggs, wheat, milk, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Spanish Rolls"[UPC#78253230919]: Packaged in a clear plastic bag, containing eight pieces, with a net weight of 14 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0231-2017·2016-11-02

    Regalo Bakery Recalls Manju Onions for Undeclared Allergens

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

    Product
    Regalo Bakery: "Manju Onions (Hopia Baboy)" [UPC#78253230918]: 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 (Devices)·Z-0096-2017·2016-11-02

    Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: 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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0238-2017·2016-11-02

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

    SM Fish Corp. is recalling 108 units of Ossie's Stiglitz Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0117-2017·2016-11-02

    St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit

    St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.

    Product
    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0243-2017·2016-11-02

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

    SM Fish Corp. is recalling 170 units of Ossie's Pickled Lox & Cream in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V797000·2016-11-02

    Isuzu and Chevrolet Trucks Recalled for Stuck Accelerator Pedal Risk

    Isuzu is recalling 2014-2016 NPR, NPR HD, and 2016 Chevrolet Low Cab Forward 3500/4500 trucks because the throttle pedal may get stuck, causing high speeds and crash risk.

    Product
    CHEVROLET — CHEVROLET, ISUZU LOW CAB FORWARD 4500, NPR HD, LOW CAB FORWARD 3500, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0240-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Swedish Matjes Herring for Listeria Risk

    SM Fish Corp. is recalling 100 units of Ossie's Swedish Matjes Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • 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