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.

23476–23500 of 32176

  • SevereFDA (Drugs)·D-481-2015·2015-04-15

    Baxter Recalls Sodium Chloride Injection Bags Due to Plastic Fragments

    Baxter Healthcare is recalling 542,080 bags of 0.9% Sodium Chloride Injection USP due to confirmed reports of blue plastic fragments from vial adapters.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1914-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Spinach Due to Listeria Contamination

    Coastal Green Vegetable Company is recalling 30,800 lbs of frozen chopped spinach because testing confirmed the presence of Listeria monocytogenes.

    Product
    -Frozen IQF 1/2 Chopped Spinach Packed in Bulk in 40 lb cases Each case is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 1431930067 Quantity: 1…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0434-2015·2015-04-15

    Wallcur Recalls Practi-0.9% Sodium Chloride Bags Due to Non-Sterility

    Wallcur Incorporated is recalling Practi-0.9% Sodium Chloride bags because they were manufactured in a non-sterile facility and are not intended for human or animal use.

    Product
    Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags, Product of China, Wallcur, San Diego, CA, 92111, USA; Wallcur Practi Products for Clinical Simulation; NDCs 5108-0954-75, 5108-0954-71, 5108-0954-72, 5108-0954-74, 5108-0954-73.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1328-2015·2015-04-15

    Lusys Laboratories Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,055 Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic purposes.

    Product
    Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1932-2015·2015-04-15

    Arcadia Trading Recalls Uneviscerated Red Thread Fish

    Arcadia Trading is recalling Red Thread Fish found to be uneviscerated. The product was distributed in seven states.

    Product
    RED THREAD FISH, NET WT: 7 OZ (200g), UPC 6 946976 817904, PRODUCT OF MYANMAR -- PACKED FOR; S W TRADING CO. HONG KONG --- The product was packed in a heat-sealed plastic bag.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1889-2015·2015-04-15

    Seattle Pops Chocolate Sea Salt Frozen Pops Recalled for Listeria Risk

    Seattle Pops is recalling Chocolate Sea Salt Frozen Pops due to potential Listeria monocytogenes contamination from an ice cream ingredient.

    Product
    Chocolate Sea Salt Frozen Pops, 4.0 fl oz. frozen pop is individually packaged in a sealed plastic bag; 24 pops/case. Product is labeled in part, "***cream, milk, skim milk powder, non-gmo cane sugar, bittersweet chocolate (chocolate liquor, sugar, cocoa, butter, soy lecithin…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1892-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Brown/Crunch Sold in Single size and 3 pack and Halloween. Ingredients: Fresh Selected Apples, Sugar, Water, Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil,Peanuts and/or corn and soy cereal parts, flour…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1334-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1891-2015·2015-04-15

    California Snack Foods Recalls Caramel Apples Due to Listeria Risk

    California Snack Foods Inc. is recalling Karm'l Dapple caramel apples because they may be associated with a Listeria monocytogenes outbreak.

    Product
    Karm'l Dapple; Net Wt. 4 oz. (124g) Red/Peanuts. Sold in Single size and 3 pack (12 oz. (340g) and Halloween. Ingredients: Fresh Selected Apples, Peanuts, Sugar, Water, Corn Syrup, Nonfat Dry Milk Solids, Cottonseed shortening and/or soybean oil,Peanuts and/or corn and soy…
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1329-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 1,015 units of Ebola Virus One Step Test Kits because they have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1916-2015·2015-04-15

    NuSpice Taco Seasoning Recalled for Potential Peanut Contamination

    Nu Products Seasoning Co. is recalling NuSpice Taco Seasoning because it may be contaminated with peanut protein from ground cumin.

    Product
    NuSpice Taco Seasoning - F4422 D, Net Wt: 48 lb packed 8/ 6 lb bags, Manufacturer: Nu Products Seasoning co., 74 Louis Court, South Hackensack, N.J. 07606
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1920-2015·2015-04-15

    Nutiva Coconut Treats Recalled Due to Salmonella Risk

    Nutiva is recalling O'Coconut Lightly Sweetened Coconut Treats because a contract manufacturer found Salmonella in the coconut flakes used to make them.

    Product
    Nutiva O'Coconut Lightly Sweetened Coconut Treat - Classic Sold in 8 - x 0.5 oz. individually wrapped pieces, UPC 6-92752-10557-9 and Singles of 24 - 0.5 oz, per box - UPC 6-92752-10500-5. - 24 singles x 6 caddies per shipping case - 144 individual units. Certified Organic…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1335-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1911-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Organic Spinach Due to Listeria

    Coastal Green Vegetable Company is recalling 398,000 lbs of frozen chopped organic spinach due to Listeria monocytogenes contamination. The product was distributed in California, Oregon, Washington, and Wisconsin.

    Product
    -Frozen IQF ¿ Chopped Organic Spinach Packed in Bulk in 1,000 lb tote bins Each tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot #…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1902-2015·2015-04-15

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria

    The Santa Barbara Smokehouse is recalling specific batches of Oakwood smoked salmon because environmental and finished product samples tested positive for Listeria monocytogenes.

    Product
    Oakwood smoked salmon mild under the following brands; Cambridge House SKU: 8 30859 01079 6, Grade A Trimmings SKU: 8 30859 02484 7 All products are vacuum packed and are either fresh or frozen. Products are cold smoked.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1918-2015·2015-04-15

    Nicomex Candy Mex Candy Coated Nuts Recalled for Allergen Mislabeling

    Nicomex Inc. is recalling Candy Mex Candy Coated Nuts because the product contains undeclared almonds and peanuts and lacks an ingredient label.

    Product
    Nicomex Candy Mex, Productos Mexicanos, Distributed by Nicomex, Inc., 88 First Street, Passaic, NJ 07055
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0431-2015·2015-04-15

    Navinta Recalls Fomepizole Injection Due to Sterility Assurance Concerns

    Navinta LLC is recalling Fomepizole Injection due to FDA inspection findings of GMP violations that may impact sterility. The recall covers 14,628 units distributed nationwide.

    Product
    Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, Rx only, Manufactured by: Emcure Pharmaceuticals Lt. for Sandoz Inc., Princeton, NJ 08540, NDC 0781-3182-73 and 0781-3182-84
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1915-2015·2015-04-15

    Giant Eagle Irish Soda Bread Recalled for Undeclared Milk Allergen

    Giant Eagle is voluntarily recalling Irish Soda Bread due to an undeclared milk allergen discovered after a customer complaint of an allergic reaction.

    Product
    Giant Eagle Irish Soda Bread, 16oz loaf, in plastic wrap, one 16oz loaf per wrapped package
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1923-2015·2015-04-15

    Talenti Sea Salt Carmel Gelato Recalled for Unlabeled Peanut Ingredient

    Unilever is recalling specific jars of Talenti Sea Salt Carmel Gelato because they may contain peanuts that are not listed on the label.

    Product
    Talenti Gelato & Sorbetto, 1 pt. (473 mL) in clear plastic jars with best by date 5/19/2016, UPC 8685200024
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1912-2015·2015-04-15

    Coastal Green Vegetable Recalls Frozen Organic Spinach for Listeria

    Coastal Green Vegetable Company is recalling 74,000 lbs of frozen organic spinach due to Listeria monocytogenes contamination.

    Product
    -Frozen IQF Cut Leaf Organic Spinach Packed in Bulk in 1,000 lb tote bins Each tote bin is tagged with a label containing the following information, item number, lot code, production date, weight, and SKU number. 00SP0241T10 Organic Spinach Cut Leaf Lot # 1431930067…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1921-2015·2015-04-15

    Nutiva Coconut Treats Recalled Due to Salmonella Contamination in Coconut Flakes

    Nutiva is recalling O'Coconut Lightly Sweetened Coconut Treats because desiccated coconut flakes used in the product tested positive for Salmonella.

    Product
    Nutiva O'Coconut Lightly Sweetened Coconut Treat - Hemp & Chia. Sold in Singles of 24 - 0.5 oz, per box - 6-92752-10502-9 24 singles x 6 caddies per shipping case - 144 individual units per case. Certified Organic, Fair Trade Certified. Manufactured for: Nutiva, 213 W.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1919-2015·2015-04-15

    Kirsch Mushroom Co. Recalls Imported Dry Mushrooms for Undeclared Sulfites

    Kirsch Mushroom Co. Inc. is recalling 495 lbs of imported dry mushrooms sold in New York due to undeclared sulfites.

    Product
    IMPORTED DRY MUSHROOMS, bulk box 30 lbs, distributed by Kirsch Mushroom Co. Inc., 751 Drake St., Bronx, NY 10474 (labeling for bulk product not provided by NYSDAM) --- Repacked product: IMPORTED DRY MUSHROOMS, WEIGHT XXX - SLOAN SUPERMARKET 494 REIMAN STREET SLOAN, N.Y. 14212…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1331-2015·2015-04-15

    Lusys Recalls Uncleared Ebola Virus One-Step Test Kits

    Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.

    Product
    Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
    Category
    Medical Device
    Distribution
    1 state