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.

24176–24200 of 32184

  • SevereFDA (Food)·F-0714-2015·2014-12-24

    House of Flavors Recalls Dark Cocoa Sorbetto for Undeclared Milk

    House of Flavors is recalling Dark Cocoa Sorbetto because it contains undeclared milk, a major allergen. This follows one reported consumer complaint of an allergic reaction to dairy.

    Product
    Dark Cocoa Sorbetto packed in 14 oz. plastic jars, 8 packages per case, manufactured from 4/11/14-4/12/14; product code: EB/JP, L3, 26-426, 14102, BEST BY October 12, 2015, BEST BY 10/15.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0716-2015·2014-12-24

    Farmer Brand Dried Lily Flowers Recalled for Undeclared Sulfites

    Blooming Import Inc. is recalling Farmer Brand Dried Lily Flowers because the product contains undeclared sulfites.

    Product
    Farmer Brand DRIED LILY FLOWERS, NET WT. 8 oz, UPC 7 34765 04089 5 -- PRODUCT OF CHINA -- DISTRIBUTED BY BLOOMING IMPORT 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- Nutrition Facts: Serving Size 0.4 oz. Servings Per Container 20 --- The product is packaged in a sealed flexible…
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·14V814000·2014-12-23

    Caterpillar Recalls 2015 CT660 and CT681 Trucks for Brake Fire Risk

    Caterpillar is recalling 57 model year 2015 CT660 and CT681 trucks because an improperly seated brake diaphragm may cause brake drag and a wheel end fire.

    Product
    CATERPILLAR — CATERPILLAR CT681, CT660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V812000·2014-12-23

    Spartan Recalls 2013-2015 Motorhomes Due to Steering Linkage Defect

    Spartan Motors is recalling 277 model year 2013-2015 motorhomes and chassis cabs because steering linkage castle nuts may loosen, potentially causing a loss of steering control.

    Product
    SPARTAN — SPARTAN MM, METROSTAR, K2, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15054·2014-12-23

    Keurig Recalls MINI Plus Brewing Systems Due to Burn Hazard

    Keurig is recalling MINI Plus Brewing Systems because water can overheat and spray out, causing burns. Consumers should contact Keurig for a free repair.

    Product
    Keurig® MINI Plus Brewing Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V811000·2014-12-22

    Suzuki Recalls Kizashi and SX4 Models for Shift Selector Defect

    Suzuki is recalling 2010-2013 Kizashi and SX4 vehicles because the shift selector can move out of Park without the brake pedal being depressed, increasing crash risk.

    Product
    SUZUKI — SUZUKI KIZASHI, SX4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·087-2014·2014-12-22

    BMG Trading Recalls Pork Leg Flank Produced Without Federal Inspection

    BMG Trading is recalling approximately 26,108 pounds of pork leg flank products that were produced without the benefit of federal inspection.

    Product
    Canadian Firm Recalls Pork Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14E084000·2014-12-19

    ZF Group Recalls 9-Speed Automatic Transmissions Due to Parking Pawl Defect

    ZF Group is recalling 9-speed automatic transmissions where a contaminated parking pawl may dislodge, preventing the vehicle from locking in Park and increasing crash risk.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V803000·2014-12-19

    Nissan Recalls 2015 Armada Vehicles for Transmission Parking Defect

    Nissan is recalling 2015 Armada vehicles because a transmission defect may prevent the parking pawl from fully engaging, allowing the vehicle to move while in Park.

    Product
    NISSAN — NISSAN ARMADA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0180-2015·2014-12-17

    Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure

    Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0707-2015·2014-12-17

    HeartLight Seafood Recalls Frozen Yellowfin Tuna Ground Meat

    Heartlight Seafood LLC is recalling 42,000 lbs of frozen yellowfin tuna ground meat due to potential high histamine levels.

    Product
    HeartLight Seafood brand Frozen Yellowfin Tuna Ground Meat (Thunnus albacares), IQF packed in a master carton of 10 x 1 lbs HDPE bags
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0296-2015·2014-12-17

    FDA Recalls Ondansetron Injection Vials Due to Sterility Concerns

    Fresenius Kabi USA is recalling 184,550 vials of Ondansetron Injection due to potential glass fractures and particles that compromise sterility.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0708-2015·2014-12-17

    Whole Foods Market Vegan Pumpkin Pie Recalled for Undeclared Walnuts

    Whole Foods Market is recalling 1,144 vegan pumpkin pies because they contain walnuts that are not listed on the label.

    Product
    Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0507-2015·2014-12-17

    TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure

    TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.

    Product
    TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V801000·2014-12-17

    Ferrara Fire Custom Trucks Recalled for Fuel Filter Defect

    Ferrara is recalling 12 model year 2014 Fire Custom trucks because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    FERRARA — FERRARA FIRE CUSTOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0562-2015·2014-12-17

    PFM Medical Recalls ASEPT Drainage Kits for Bacterial Endotoxin Concerns

    PFM Medical is recalling ASEPT 600 ml Drainage Kits because they may exceed USP limits for bacterial endotoxin. The recall affects 1,470 units distributed in the US and abroad.

    Product
    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2015·2014-12-17

    Fresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns

    Fresenius Kabi USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.

    Product
    CYANOCOBALAMIN — CYANOCOBALAMIN (CYANOCOBALAMIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0523-2015·2014-12-17

    Siemens Mammomat Inspiration System Recalled for Potential Instability

    Siemens is recalling three Mammomat Inspiration systems because the workstation table may fall over if not secured, posing a risk of serious injury.

    Product
    Mammomat Inspiration system: Product Usage: mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film or soft copy workstation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0621-2015·2014-12-17

    Wawona Packing Recalls Pluots, Peaches, Nectarines, and Plums for Listeria Risk

    Wawona Packing Company is recalling certain lots of pluots, peaches, nectarines, and plums packed in 2014 due to potential Listeria monocytogenes contamination.

    Product
    Pluot: Product of USA: Brand names: Sweet 2 Eat, Sweet 2 Eat Organic Orchard Perfect, Trader Joes, Sam's, Mrs. Smittcamp's, Harvest Sweet, Wawona, Costco, Sweet O. Brand names: Sweet 2 Eat, Orchard Perfect, Trader Joe's, Sam's, Mrs. Smittcamp's, Harvest…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0590-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 45 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0524-2015·2014-12-17

    Medtronic MiniMed Infusion Sets Recalled Due to Tubing Detachment Risk

    Medtronic MiniMed is recalling Silhouette and Sure-T infusion sets because tubing may detach, interrupting insulin delivery without an alarm.

    Product
    Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T…
    Category
    Medical Device
    Distribution
    Distributed nationwide