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.

17376–17400 of 29217

  • 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
  • SevereNHTSA·16V784000·2016-10-27

    Holiday Rambler Vacationer Motorhomes Recalled for Front Truss Support Defect

    REV Recreation Group is recalling 2015-2016 Holiday Rambler Vacationer motorhomes because a front truss may not be adequately supported, risking wire or hydraulic line damage.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER VACATIONER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0217-2017·2016-10-26

    Fresh From Texas Recalls Fruit Party Tray for Listeria Risk

    Fresh From Texas Inc. is recalling 45 oz. Fruit Party Trays due to potential Listeria monocytogenes contamination. The product was distributed in Texas.

    Product
    Fruit Party Tray 45 oz. UPC 4122087997 packaged in clear plastic rectangle container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0123-2017·2016-10-26

    Kabobs Mini Classic French Quiche Recalled for E. coli O121 Contamination

    Kabobs Inc is recalling Mini Classic French Quiche because it was manufactured with flour contaminated with E. coli O121.

    Product
    MINI CLASSIC FRENCH QUICHE, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260.
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-0207-2017·2016-10-26

    QualiTech FE Maple Recalled for Potential E. coli O121 Contamination

    QualiTech is recalling FE Maple product code 27128 due to potential E. coli O121 bacteria. The product was distributed in ten US states and Canada.

    Product
    FE Maple, Product Code 27128. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereNHTSA·16V779000·2016-10-26

    Ford Recalls 2015-2017 Mustangs for Engine Oil Cooler Hose Defect

    Ford is recalling 2015-2017 Mustangs because an engine oil cooler hose may separate, causing an oil leak that could lead to engine failure or fire.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0192-2017·2016-10-26

    QualiTech Recalls FE Carrot 281 Due to Potential E. coli O121 Presence

    QualiTech is recalling FE Carrot 281 because a supplier notified them of potential E. coli O121 bacteria in the material.

    Product
    FE Carrot 281, Product Code 22281. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0119-2017·2016-10-26

    Synergetics VersaVit 2.0 Procedure Packs Recalled for Pressure Defect

    Synergetics Inc is recalling 72 units of 25 gauge VersaVit 2.0 Core Essentials Procedure Packs because the vitrectomy cutters do not operate within correct pressure pulse specifications.

    Product
    25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Food)·F-0200-2017·2016-10-26

    QualiTech Recalls Jalapeno Product Due to Potential E. coli O121 Contamination

    QualiTech is recalling 3,200 lbs of FE Jalapeno 709 due to potential E. coli O121 contamination. The product was distributed in 10 US states and Canada.

    Product
    FE Jalapeno 709, Product Code 22709. 50 lb corrugated case with polyliner. Manufactured by: Quali Tech, 318 Hazel tine Drive, Chasma, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0177-2017·2016-10-26

    Dollar General Recalls Mold-Contaminated Soft Baked Chocolate Brownie Cookies

    Dollar General is recalling Soft Baked Chocolate Brownie Cookies due to the presence of mold. Consumers should discard the product or return it for a refund.

    Product
    Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0221-2017·2016-10-26

    Fresh From Texas Recalls HEB Fruit Medley Due to Listeria Risk

    Fresh From Texas Inc. is recalling HEB Ready Fresh Go Fresh Fruit Medley 7 oz. packages due to potential Listeria monocytogenes contamination.

    Product
    HEB Ready Fresh Go Fresh Fruit Medley 7 oz. UPC 4122002402 packaged in clear plastic tray
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0194-2017·2016-10-26

    QualiTech Recalls Jalapeno Product Due to Potential E. coli O121 Presence

    QualiTech is recalling FE Jalapeno 321A because a supplier reported the potential presence of E. coli O121 bacteria.

    Product
    FE Jalapeno 321A, Product Code 22321A. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-0231-2017·2016-10-26

    Windstone Medical Recalls Major General Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.

    Product
    Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide