The Recall Desk

Archive

April 2015 recalls

1,319 recalls were announced in April 2015.

What the numbers show

Critical
109
Severe
527
High
388
Moderate
278
Low
17

Of the 1,319 recalls this month scored against our rubric, 8% are Critical, 40% are Severe.

1301–1319 of 1319

  • HighFDA (Food)·F-1628-2015·2015-04-01

    Taj Ethnic Gourmet Punjabi Saag Spinach Sauce Recalled for Undeclared Peanut

    The Hain Celestial Group is recalling Taj Ethnic Gourmet Punjabi Saag Spinach Sauce because it may contain undeclared peanut protein.

    Product
    Taj ETHNIC GOURMET PUNJAB SAAG Spinach Sauce, NET WT 16.0 OZ. (454.0g), UPC 7 18687 30013 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1593-2015·2015-04-01

    Parade Taco Dinner Kit Recalled for Undeclared Peanuts

    Dursett Amigos, Ltd is recalling Parade Taco Dinner Kits because they contain undeclared peanuts. The recall covers 56 cases distributed in four states.

    Product
    Parade Taco Dinner Kit Includes Shells, Seasoning and Sauce Net Wt. 9.75 oz. (276 g); UPC:050700091518; DISTRIBUTED BY FEDERATED GROUP, INC. 3025 W. SALT CREEK LN. ARLINGTON HEIGHTS, IL 60005
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1315-2015·2015-04-01

    Leica CD15 Antibody Recalled for Decreasing Staining Intensity

    Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.

    Product
    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any sta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2015·2015-04-01

    Aaren Scientific Recalls Intraocular Lenses Due to Non-Compliant Instructions

    Aaren Scientific is recalling 28 intraocular lenses because the instructions for use do not fully comply with US requirements.

    Product
    Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataract
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1319-2015·2015-04-01

    In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity

    In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.

    Product
    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1321-2015·2015-04-01

    Siemens ADVIA Chemistry Systems Drug Calibrator I Recalled for Incorrect Values

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, due to incorrect calibrator values for Phenytoin 2 and Phenobarbital 2 assays.

    Product
    ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1614-2015·2015-04-01

    Sunshine Burger Recalls Gluten-Free Veggie Burgers Due to Gluten Testing

    Sunshine Burger & Specialty Food Company is recalling 4,113 packages of Organic Sunshine Burgers because gluten testing revealed levels above 20 ppm in products labeled gluten-free.

    Product
    Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan Barbecue 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Best Before: 5/4/16; 6/11/2016; 8/13/16; CANADIAN: Organic Sunshine Burgers Barbecue 3 Organic Veggi
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1615-2015·2015-04-01

    Sunshine Organic Veggie Burgers Recalled for Gluten Contamination

    Sunshine Burger & Specialty Food Company is recalling frozen veggie burgers labeled gluten-free because testing found gluten levels above 20 ppm.

    Product
    Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan South West 3 Organic Veggie Burgers Keep Frozen Net WT: 8 OZ. Use By: 7/13/16; 7/21/16; 7/28/16; 8/4/16; 8/11/16; FOOD SERVICE: Sunshine Southwestern Style Veggie B
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1320-2015·2015-04-01

    Roche Recalls cobas EGFR Mutation Test Kits Due to False Positives

    Roche Molecular Systems is recalling 190 kits of the cobas EGFR Mutation Test because they may produce false positive results for Exon 20 insertion mutations.

    Product
    cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1311-2015·2015-04-01

    CareFusion Recalls Alaris PC Infusion Pumps Due to Keypad Error Code

    CareFusion 303, Inc. is recalling 56,015 Alaris PC infusion pumps because a keypad issue may trigger an error code during the power-on self-test.

    Product
    Alaris PC units, Model No. 8015. Infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1325-2015·2015-04-01

    Zimmer NexGen Trabecular Metal Femoral Augment Block Mislabeled Recall

    Zimmer Trabecular Metal Technology is recalling one unit of a NexGen femoral augment block that was mislabeled as 5 mm instead of 20 mm.

    Product
    NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Kn
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1323-2015·2015-04-01

    ArthroCare Recalls 15 Coblator II Systems Due to Component Reversal

    ArthroCare Medical Corporation is recalling 15 Coblator II systems because specific components were reversed on the controller boards.

    Product
    Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1313-2015·2015-04-01

    Synthes Electric Pen Drive Hand Switch Labeling Error Recall

    Synthes, Inc. is recalling 249 Electric Pen Drive systems because the Hand Switch labels for 'on' and 'lock' were interchanged.

    Product
    Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1574-2015·2015-04-01

    Cocola Macaroons Recalled for Undeclared Colors

    Cocola INC is recalling Cocola Macaroons due to a complaint regarding undeclared colors in the product.

    Product
    Cocola Macaroons; Each box contains 5 flavors (3 ct each): Mango Passion, Raspberry, Pistachio, Coffee, and Chocolate. Net wt. 7 oz. ; UPC 091037037985. Ingredient: Fresh Egg White, Mango Puree, Passion Fruit Puree, Granulated sugar, powdered sugar, Almond Flour,Butter N&A co
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0420-2015·2015-04-01

    West-Ward Recalls Fentanyl Citrate Injections Due to Impurity Failures

    West-Ward Pharmaceutical is recalling Fentanyl Citrate injections because the product failed impurity and degradation specifications and 12-month stability testing.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1318-2015·2015-04-01

    In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity

    In2Bones is recalling 35 units of DUAFIT PIP 0o CA Size 2 interphalangeal implants because dimensional non-conformity prevents them from fitting into the dedicated holder.

    Product
    DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0427-2015·2015-04-01

    American Specialty Pharmacy Recalls Hydroxocobalamin Injection Due to Particulate Matter

    American Specialty Pharmacy is recalling 15 vials of Hydroxocobalamin Injection Solution 1 mg/mL due to the presence of particulate matter and potential preservative issues.

    Product
    Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
    Category
    Drug
    Distribution
    1 state

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