The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

10376–10400 of 29158

  • SevereFDA (Drugs)·D-0632-2020·2020-01-08

    Ranitidine Tablets Recalled Due to NDMA Impurity

    Granules India Limited is recalling Ranitidine tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0631-2020·2020-01-08

    American Health Packaging Recalls Ranitidine Syrup Due to NDMA Impurity

    American Health Packaging is recalling specific lots of Ranitidine Syrup because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0746-2020·2020-01-08

    Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk

    Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.

    Product
    HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·001-2020·2020-01-03

    Kettle Cuisine Recalls Lentil and Beef Soup for Undeclared Allergens

    Kettle Cuisine Midco, LLC is recalling ready-to-eat lentil and beef soup products because they contain undeclared egg and wheat allergens.

    Product
    Kettle Cuisine Midco, LLC — Kettle Cuisine Midco, LLC, Recalls Ready-To-Eat Soup Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·20E001000·2020-01-02

    Takata Frontal Air Bag Inflators Recalled for Explosion Risk

    Takata is recalling specific non-desiccated frontal air bag inflators used as interim remedies. These inflators may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V003000·2020-01-02

    Subaru and Saab Recall Vehicles Due to Air Bag Inflator Defect

    Subaru is recalling specific 2003-2014 models and Saab 9-2X vehicles because passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    SUBARU — SUBARU, SAAB OUTBACK, BAJA, IMPREZA, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V002000·2020-01-02

    Subaru and Saab Recall Vehicles Due to Air Bag Inflator Defect

    Subaru and Saab are recalling specific model years because passenger air bag inflators may explode due to humidity, posing a risk of serious injury.

    Product
    SUBARU — SUBARU, SAAB OUTBACK, BAJA, IMPREZA, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0428-2020·2020-01-01

    Fuji Food Products Recalls Okami Tempura Shrimp Rolls Due to Listeria Risk

    Fuji Food Products is recalling Okami OK Tempura Shrimp Roll products because they may be contaminated with Listeria monocytogenes. The recall covers units distributed in multiple states.

    Product
    Okami OK Tempura Shrimp Roll, 6pc w/ Sweet and Dynamite Sauce, SKU 28114
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0432-2020·2020-01-01

    Trader Joe's Shrimp Spring Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Shrimp Spring Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's Shrimp Spring Rolls 7oz, SKU 908795
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0427-2020·2020-01-01

    Fuji Food Products Recalls Seafood Combo for Listeria Risk

    Fuji Food Products is recalling Okami 8pc Seafood Combo products due to potential Listeria monocytogenes contamination.

    Product
    Okami 8pc SEAFOOD COMBO 6 SURIMI 2 EBI SHRIMP, SKU 28262
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0433-2020·2020-01-01

    Trader Joe's Tofu Spring Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Tofu Spring Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's Tofu Spring Rolls 7oz, SKU 921510
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0460-2020·2020-01-01

    Northern Fisheries Recalls Frozen Yellowfin Tuna Ground Meat Due to Histamine

    Northern Fisheries Ltd. is recalling 1,251 cases of frozen yellowfin tuna ground meat because it may contain increased levels of histamine, posing a risk of scombrotoxin fish poisoning.

    Product
    Frozen Yellowfin Tuna Ground Meat, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0415-2020·2020-01-01

    Trader Joe's Smoked Salmon Philly Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Smoked Salmon Philly Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Smoked Salmon Philly Roll, SKU 603775
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0434-2020·2020-01-01

    Trader Joes Queso Fundido 16oz Recalled for Listeria Contamination

    Trader Joes Queso Fundido 16oz is recalled due to potential Listeria monocytogenes contamination. The product was distributed in multiple states.

    Product
    Trader Joes Queso Fundido 16oz, SKU 646574
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0419-2020·2020-01-01

    FDA Recalls Okami California Rolls Due to Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Supreme California Rolls because they may be contaminated with Listeria monocytogenes.

    Product
    Okami brand 8pc Supreme California Roll, SKU 28103
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Devices)·Z-0021-2020·2020-01-01

    Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect

    Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.

    Product
    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0410-2020·2020-01-01

    Lin's Waha International Recalls Suantianyangmei Waxberry for Undeclared Sulfites

    Lin's Waha International Corp. is recalling Suantianyangmei Waxberry because the product contains undeclared sulfites and cyclamates.

    Product
    Suantianyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407226 and 3.12.2020 stamped on the box
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0412-2020·2020-01-01

    Trader Joe's Spicy California Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Spicy California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Spicy California Roll, 8oz, SKU 00348966T
    Category
    Food
    Distribution
    31 states
  • SevereNHTSA·19V925000·2019-12-30

    Toyne Recalls 2018-2019 Spartan Metro Star and Gladiator Chassis

    Toyne Inc. is recalling 2018-2019 Spartan Metro Star and Gladiator chassis due to a brake relay valve defect that may increase stopping distance.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0364-2020·2019-12-25

    Whole Foods Recalls Salad Bar Pesto for Listeria Risk

    Whole Foods Market is recalling PIZZA PESTO GREEN VEGGIE from salad bars due to possible Listeria monocytogenes contamination.

    Product
    PIZZA PESTO GREEN VEGGIE served on the salad bar
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0630-2020·2019-12-25

    Lannett Recalls Levetiracetam Oral Solution Due to Microbial Contamination

    Lannett Company is recalling specific lots of Levetiracetam Oral Solution because testing found out-of-specification microbial counts.

    Product
    Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
    Category
    Drug
    Distribution
    Distributed nationwide