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.

13876–13900 of 29188

  • SevereFDA (Food)·F-1802-2018·2018-08-08

    Sugar Foods Recalls Cheese Garlic Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling HMS Cheese Garlic Croutons because they were produced using recalled whey powder.

    Product
    HMS Cheese Garlic Croutons: 2.5 lb. foil pouch Item # 74906 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2559-2018·2018-08-08

    Galt Medical Recalls Vascular Dilators and Introducer Kits Due to Endotoxins

    Galt Medical Corporation is recalling specific vascular dilators and introducer kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2558-2018·2018-08-08

    Galt Medical Recalls Sterile Hemostasis Valve Introducer Systems Due to Endotoxins

    Galt Medical Corporation is recalling specific sterile hemostasis valve introducer systems and kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #…
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1728-2018·2018-08-08

    Bengard Ranch Recalls Fresh Cilantro Due to Salmonella Contamination

    Bengard Ranch is recalling fresh cilantro after FDA surveillance samples tested positive for Salmonella. The product was distributed directly to Texas.

    Product
    Fresh Cilantro: Boxed by Sabor Farms, Salinas, CA 60 bunches of cilantro per box
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1800-2018·2018-08-08

    Sugar Foods Recalls Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling First Street Restaurant Style Seasoned Croutons because they were made with recalled whey powder.

    Product
    First Street Restaurant Style Seasoned Croutons: 24 oz. foil pouch Item # 31424 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1805-2018·2018-08-08

    Sugar Foods Recalls Sizzler Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling Sizzler HMS Seasoned Croutons because they were made with recalled whey powder. The product was distributed in six states.

    Product
    Sizzler HMS Seasoned Croutons: 2.5 lb. foil pouch Item # 74803 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1028-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1807-2018·2018-08-08

    Sugar Foods Croutons Recalled Due to Contaminated Whey Ingredient

    Sugar Foods Corporation is recalling seasoned croutons because they were made with recalled whey powder.

    Product
    Classic Sysco cube seasoned croutons: 0.25 oz. plastic pouch Item # 20602 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1027-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1029-2018·2018-08-08

    Bryant Ranch Recalls Valsartan Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1020-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1679-2018·2018-08-08

    LAXMI Corn Flour Recalled Due to High Aflatoxin Levels

    House of Spices (India) Inc. is recalling LAXMI Corn Flour because it contains high levels of aflatoxin.

    Product
    LAXMI Corn Flour Fine Net Wt./Poids Net. 2LB (907g) Distributed by: House of Spices (India) Inc.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2563-2018·2018-08-08

    Galt Medical Recalls Centeze Centesis Catheters Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1798-2018·2018-08-08

    Sugar Foods Recalls Homestyle Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling 4 oz. pouches of Homestyle Seasoned Croutons because they were produced using recalled whey powder.

    Product
    Homestyle Seasoned Croutons: 4 oz. foil pouch Item # 73689 UPC 10083661736898 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1804-2018·2018-08-08

    Sugar Foods Recalls Italian Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling 1 lb. foil pouches of Homestyle Italian Seasoned Croutons because they were made with recalled whey powder.

    Product
    Homestyle Italian Seasoned Croutons: 1 lb. foil pouch Item # 74384 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1021-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1806-2018·2018-08-08

    Sugar Foods Recalls Garlic Butter Focaccia Crumbles Due to Whey Powder Issue

    Sugar Foods Corporation is recalling Garlic Butter and Black Pepper Focaccia Crumbles because they were made with recalled whey powder.

    Product
    Garlic Butter and Black Pepper Focaccia Crumbles: 400 lb. Gaylord Tote Item # 78939 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1023-2018·2018-08-08

    Pfizer Recalls Daptomycin Injection Due to Microbial Contamination

    Pfizer is recalling Daptomycin for Injection due to reports of adverse events indicative of infusion reactions related to microbiological contamination.

    Product
    Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2594-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk

    Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2599-2018·2018-08-08

    Beckman Coulter MicroScan Pos Combo Panel Type 43 Recalled for Incorrect Moxifloxacin Dilution

    Beckman Coulter is recalling MicroScan Pos Combo Panel Type 43 because an incorrect Moxifloxacin dilution sequence may cause inaccurate antimicrobial susceptibility results.

    Product
    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and…
    Category
    Medical Device
    Distribution
    12 states
  • SevereNHTSA·18V520000·2018-08-07

    Terex Recalls 2015-2018 Digger Derricks Due to Weld Defect

    Terex is recalling 2015-2018 C4000, C5000, C6000, and General 80 digger derricks because undersized welds may cause the auger to fall unexpectedly, posing an injury risk.

    Product
    TEREX — TEREX C4000, GENERAL 80, C6000, C5000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V521000·2018-08-07

    BYD Recalls 2016-2017 K11 M Buses Due to Brake Caliper Defect

    BYD is recalling 2016-2017 K11 M hybrid buses because a brake caliper guide pin may break, potentially causing loss of braking ability or tire pressure.

    Product
    BYD — BYD K11 M
    Category
    Vehicle
    Distribution
    Distributed nationwide