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.

20901–20925 of 32121

  • SevereNHTSA·16V011000·2016-01-13

    Gillig Recalls 2010-2015 Low Floor Buses Due to Seat Belt Defect

    Gillig is recalling 6,734 Low Floor transit buses from 2010-2015 because missing welds on seat brackets could cause seat belts to detach during a crash.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0433-2016·2016-01-13

    Pine Valley Foods Recalls Cookie Dough for Undeclared Milk and Egg

    Pine Valley Foods is recalling specific batches of pre-portioned cookie dough because they contain undeclared milk or egg allergens.

    Product
    Crazy about Cookies 2.7lb WALNUT CHUNKY CHOCOLATE CHIP Pre-Portioned cookie dough Item # 25-2008 UPC Code - 698768102168
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0427-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Holiday Gathering COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4034 UPC Code - 698768034346
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0420-2016·2016-01-13

    ConAgra Recalls David Trail Mix Sweet & Salty for Undeclared Milk

    ConAgra Foods is recalling David Trail Mix Sweet & Salty bags because they contain undeclared milk. The product was distributed nationwide and to specific foreign locations.

    Product
    David Trail Mix Sweet & Salty individual plastic bags net wt. 5 oz. (142 g) UPC 00 26200 23885 2 shipped in the following configurations: 1) cases of eight (8) with UPC 20-0-26200-23885-6; 2) 36-count multi-pack shipper case UPC 00-0-26200-23890-6 which contains 16…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0588-2016·2016-01-13

    Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter Recall for Handle Separation

    Boston Scientific is recalling ACUITY Pro Coronary Sinus Guide Catheters due to a potential for the proximal handle to separate from the shaft.

    Product
    Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0466-2016·2016-01-13

    Kroger Bakery Fresh Goodness Chocolate Brownie Recalled for Undeclared Walnuts

    The Kroger Co is recalling Bakery Fresh Goodness Chocolate Brownies because a consumer reported undeclared walnuts in the product.

    Product
    BAKERY FRESH GOODNESS Chocolate Brownie NET WT 16 OZ (1 LB) 453 g CONTAINS: MILK, EGGS, WHEAT, SOY. MAY CONTAIN: ALMONDS, PECANS, WALNUTS, CASHEWS, COCONUT. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 09172 7
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-0478-2016·2016-01-13

    Stryker Fuhrman Pleural Drainage Set Recalled for Breakage During Insertion

    Stryker is recalling 34 Fuhrman Pleural/Pneumopericardial Drainage Sets because they broke off in the pleural cavity during patient insertion.

    Product
    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Food)·F-0426-2016·2016-01-13

    Pine Valley Foods Recalls Sugar and Walnut Cookie Dough for Allergens

    Pine Valley Foods is recalling pre-portioned sugar and walnut chocolate chunk cookie dough because they contain undeclared milk and egg, respectively.

    Product
    Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code - 698768102120
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0430-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Birthday Celebration COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4033 UPC Code - 698768034339
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0432-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookies for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie products due to undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb DSC Custom Decorated Sugar Cookies Item # 101-2207 thru 101- 2355 UPC Code - None
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0429-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific sugar cookie kits because they contain undeclared milk and egg allergens.

    Product
    Crazy about Cookies 2lb Monster Bash COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4032 UPC Code - 698768034322
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0431-2016·2016-01-13

    Pine Valley Foods Recalls Sugar Cookie Kits for Undeclared Allergens

    Pine Valley Foods is recalling specific Hello Kitty sugar cookie kits because they contain undeclared milk and egg.

    Product
    Crazy about Cookies 2lb HELLO KITTY COLLECTION Decorated SUGAR COOKIE KIT Item # 03-4035 UPC Code - 698768034353
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E001000·2016-01-12

    Wells Recalls Brake Light Switches for Potential Failure to Illuminate

    Wells Vehicle Electronics is recalling specific brake light switches that may fail to illuminate brake lights or disengage cruise control, increasing crash risk.

    Product
    EXTERIOR LIGHTING:BRAKE LIGHTS:SWITCH recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0441-2016·2016-01-06

    Tate's Bake Shop Recalls Cookies for Undeclared Walnuts

    Tate's Bake Shop is recalling Chocolate Chip and Ginger Zinger Cookies because they contain undeclared walnuts.

    Product
    TATE'S BAKE SHOP Cookies GINGER ZINGER GLUTEN FREE, NET WT. 7 OZ (198 G), UPC Code 810291001095, product is packed in plastic which is inserted into a mint green paper wrapper, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0557-2016·2016-01-06

    Elekta Recalls MOSAIQ Oncology System Due to Dosage Calculation Error

    Elekta, Inc. is recalling 399 units of the MOSAIQ Oncology Information System because a software issue with age and weight data can cause incorrect drug dosages.

    Product
    MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0550-2016·2016-01-06

    Clindamycin Injection Bags Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Clindamycin injection Accuflo bags in Texas due to a lack of assurance of sterility.

    Product
    Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0548-2016·2016-01-06

    Teflaro Infusion Minibags Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Teflaro 600 mg infusion minibags due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0552-2016·2016-01-06

    Remicade Injection Recalled for Lack of Sterility Assurance

    Walgreens Infusion Services is recalling Remicade (Infliximab) injection bags in Texas due to a lack of assurance of sterility.

    Product
    Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0449-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Unlabeled Eggs

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Esquimal eskimo; Net Wt. 3 FL oz; UPC 6 34242 20012 8; INGREDIENTS: ICE CREAM MIX (CREAM, MILK, NONFAT MILK SOLIDS, STABILIZER (LOCUST BEAN GUM, GUAR GUM)), WATER, SUGAR, VANILLA FLAVOR (PROPYLENE GLYCOL, WATER AND CARAMEL COLOR)…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0448-2016·2016-01-06

    Helados La Tapatia Creamy Fruit Bars Recalled for Undeclared Egg

    Helados La Tapatia is recalling Creamy Fruit Bars because the ice cream mix contains eggs that are not listed on the ingredient label.

    Product
    Helados La Tapatia Creamy Fruit Bars; Cookies "n" Cream; Net Wt. 3 FL oz; UPC 6 34242 20010 4; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN}, CHOCOLATE…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0555-2016·2016-01-06

    Walgreens Infusion Services Recalls Dextrose and Sodium Chloride Injection Bags

    Walgreens Infusion Services is recalling 9 bags of Dextrose 5% and 0.9% Sodium Chloride injection due to a lack of assurance of sterility.

    Product
    Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL, b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0532-2016·2016-01-06

    Walgreens Recalls Primaxin Infusion Minibags Due to Sterility Concerns

    Walgreens Infusion Services is recalling 40 minibags of Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL due to a lack of assurance of sterility. The affected products were distributed in Texas.

    Product
    Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0440-2016·2016-01-06

    Tate's Bake Shop Recalls Chocolate Chip Cookies for Undeclared Walnuts

    Tate's Bake Shop is recalling Chocolate Chip Cookies and Ginger Zinger Cookies because they contain undeclared walnuts.

    Product
    TATE'S BAKE SHOP CHOCOLATE CHIP COOKIES, NET WT. 7 OZ (198 G), UPC Code 810291001002, product is packed in plastic which is inserted into green paper wrapping, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0526-2016·2016-01-06

    Walgreens Recalls Pedi MVI Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling 73 syringes of Pedi MVI in Texas due to a lack of assurance of sterility.

    Product
    Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0544-2016·2016-01-06

    Walgreens Recalls Sodium Ascorbate Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling compounded Sodium Ascorbate (Vitamin C) syringes in Texas due to a lack of assurance of sterility.

    Product
    Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
    Category
    Drug
    Distribution
    1 state