The Recall Desk

Archive

August 2015 recalls

585 recalls were announced in August 2015.

What the numbers show

Critical
75
Severe
90
High
176
Moderate
225
Low
19

Of the 585 recalls this month scored against our rubric, 13% are Critical, 15% are Severe.

201–300 of 585

  • SevereFDA (Devices)·Z-2373-2015·2015-08-19

    Fresenius Medical Care Recalls Naturalyte Liquid Bicarbonate Concentrate

    Fresenius Medical Care is recalling Naturalyte Liquid Bicarbonate Concentrate due to potential bacterial contamination. The recall covers 2,264,028 units distributed nationwide.

    Product
    Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Concentrate for Hemodialysis (liquid) Product Code: 08-4000-LB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2950-2015·2015-08-19

    Lion Pavilion Tasty Peach Slices Recalled for Undeclared Sulfites

    Lion Pavilion Ltd. is recalling Tasty Peach Slices due to undeclared sulfites detected by New York State authorities.

    Product
    Tasty Peach Slices, NET WT. 3.87 OZ (110g), UPC 6 949663 601787 -- Product of China --- The product was packed in a clear plastic bottle/jar. --- 12.75 mg sulfites per serving.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2956-2015·2015-08-19

    FDA Recalls Maxam Products for Unapproved Drug Claims

    James G. Cole, Inc. is recalling all Maxam brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.

    Product
    ALL MAXAM PRODUCTS: The Maxam product is used orally in spray form and bears the Maxam label. ********The List of MAXAM products********************************************** AD Nutritional Support for a Positive Outlook; AFX Nutritional Support for Healthy Cellular
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect

    Trumpf Medical Systems is recalling TruLight 3000/5000 surgical lights because the front joint of the spring arm could break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2381-2015·2015-08-19

    Etac Relax Wall Mounted Shower Seat Recalled for Cracked Brackets

    Etac Supply Center Ab is recalling 13 units of the Etac Relax wall mounted shower seat due to reports of the wall bracket cracking or breaking.

    Product
    Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower seat designed as a seating and standing support for personal hygiene purposes for people with reduced mobility. The Etac Relax shower seat is used for sitting where space is restricted, and can be folded
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled Due to Spring Arm Defect

    Trumpf Medical Systems is recalling 9,287 ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2957-2015·2015-08-19

    ASN Dietary Supplements Recalled for Unapproved Drug Claims

    James G. Cole, Inc. is recalling all ASN brand products nationwide because they are misbranded, adulterated, and unapproved new drugs.

    Product
    ALL ASN products: The ASN products are in capsule or powdered form and bear the ASN label. *********the List of ASN products***************************** AFINITY WHEY PROTEIN; DHEA; HUMAGRO Homeopathic Growth Hormone 4c; PHYTOBOL; TESTRX; TRIBESTRONE II;
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2952-2015·2015-08-19

    D & D Foods Recalls Dijon Mustard Potato Salad for Allergen Mislabeling

    D & D Foods is recalling 110 cases of Dijon Mustard Potato Salad sold in Hy-Vee stores because the product contains milk and wheat but fails to disclose these allergens.

    Product
    Dijon Mustard Potato Salad, NET WT 3 LB (1.36 kg)
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2350-2015·2015-08-19

    Remel Recalls PathoDx Strep Grouping Kits Due to Reagent Issues

    Remel Inc is recalling 1,859 PathoDx Strep Grouping Kits because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2962-2015·2015-08-19

    FITzee Foods Recalls Paleo Turkey Meatloaf Due to Listeria Risk

    Optimal Nutrition is recalling FITzee Foods Paleo Turkey Meatloaf because it contains green beans affected by a Listeria monocytogenes recall.

    Product
    FITzee Foods Paleo Turkey Meatloaf all sizes (small, medium, large and XL)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2958-2015·2015-08-19

    Niagara Bottling Recalls Spring Water Brands Due to E. coli Contamination

    Niagara Bottling, LLC is recalling multiple brands of natural spring water because source water tested positive for E. coli and total coliform.

    Product
    Acadia Natural Spring Water, 16.9 Fl Oz, Distributed by FoodHold USA, Inc, Landover, MD 20785; Acadia Natural Spring Water, 8 Fl Oz, Distributed By: FoodHold USA, LLC, Landover, MD 20785; Acme Natural Spring Water, 16.9 Fl Oz., Distributed By Supervalu, inc., Eden Prairie,
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-2944-2015·2015-08-19

    Pride of Africa Enriched Farina Recalled for Undeclared Wheat Allergen

    Raymond-Hadley Corp. is recalling Pride of Africa Enriched Farina because the label failed to declare the presence of wheat.

    Product
    Pride of Africa brand Enriched Farina, Net Weight 5 lb. (2.27 kg), UPC 016712016840 --- Product of The Raymond-Hadley Corp. Spencer, NY 14883 --- Product is packaged in a clear plastic pouch with green, brown and white artwork.
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·15V530000·2015-08-19

    Thor Motor Coach Recalls 2016 Vegas and Axis RVs for HVAC Defect

    Thor Motor Coach is recalling 290 model year 2016 Vegas and Axis recreational vehicles because the HVAC control may lock, preventing windshield defrosting and increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH VEGAS, AXIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2959-2015·2015-08-19

    Restaurant Depot Recalls Frozen Garden Peas Due to Listeria Contamination

    Restaurant Depot is recalling James Farm Garden Peas Chicharos due to Listeria monocytogenes contamination. The product was distributed in Connecticut, Massachusetts, New Jersey, New York, and Pennsylvania.

    Product
    JAMES FARM GARDEN PEAS CHICHAROS, NET Wt. 40 OZ (2.5 LBS), FRESH FROZEN, UPC 7 60695 01000, product is packed in plastic bags and shipped as 12 units/40 oz. per carton, Net Wt. 30lb. Distributed by RD/Jet, LLC 15-24 132 nd Street College Point, NY 11356. PRODUCT OF POLAND.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2946-2015·2015-08-19

    Novacare Recalls Glucosamine Capsules Due to Inadequate Allergen Labeling

    Novacare, LLC is recalling 961 bottles of Glucosamine 750 mg capsules nationwide because the product has inadequate allergen labeling.

    Product
    Glucosamine 750 mg 120 ct, Capsule, Dosage: 12 capsules, 750 mg ea., three times daily with meals
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect

    Trumpf Medical Systems is recalling 9,287 surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2015·2015-08-19

    Synthes Recalls 8.5mm Reamer Heads for Potential Intraoperative Breakage

    Synthes (USA) Products LLC is recalling 8.5mm Reamer Heads for Flexible Intramedullary Nailing Systems due to the possibility of intraoperative breakage and un-retrieved material fragments.

    Product
    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2356-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled Due to Joint Breakage Risk

    Trumpf Medical Systems is recalling ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia SD, User Manual #1400191. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2323-2015·2015-08-19

    Alcon ReSTOR Intraocular Lenses Recalled for Post-Operative Inflammation Reports

    Alcon Research, Ltd. is recalling ReSTOR intraocular lenses manufactured for Japan due to reports of post-operative inflammation and toxic anterior segment syndrome (TASS). No US distribution occurred.

    Product
    ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to replace the human crystalline lens in adult patients following cataract surgery.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·15V531000·2015-08-19

    Thor Motor Coach Recalls Tuscany XTE Motorhomes for Table Defect

    Thor Motor Coach is recalling 2014-2015 Tuscany XTE motorhomes because the dinette table insert may flip up if sat on, posing a fall risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY XTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2015·2015-08-19

    Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Joint Breakage Risk

    Trumpf Medical Systems is recalling ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.

    Product
    Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2015·2015-08-19

    B. Braun Recalls Celsite Implantable Access Port Systems Due to Endotoxin

    B. Braun Interventional Systems is recalling 11 Celsite Implantable Access Port Systems because endotoxin test results were out of specification.

    Product
    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2366-2015·2015-08-19

    Hitachi Oasis MRI Coil Extension Cable Recalled for Overheating Burn Hazard

    Hitachi Medical Systems America Inc is recalling 173 Oasis Coil Extension Cables used with MRI systems because they may overheat and cause burns.

    Product
    Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2015·2015-08-19

    Sensodyne Toothpaste Recalled Due to Wood Fragments

    GlaxoSmithKline is recalling Sensodyne toothpaste tubes because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2380-2015·2015-08-19

    Boston Scientific Recalls AngioJet AVX Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet AVX Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing th
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1318-2015·2015-08-19

    Biotene Fluoride Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene fluoride toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    BIOTENE — BIOTENE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2364-2015·2015-08-19

    Cadence Recalls Perfectum Tuberculin Glass Syringes Due to Misaligned Marks

    Cadence Inc. is recalling 766 non-sterile Perfectum Tuberculin Glass Syringes because graduation marks are not centered with numeric position marks.

    Product
    Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2015·2015-08-19

    GE Laser Centering Device Recalled for Regulatory Non-Compliance

    GE Inspection Technologies is recalling 25 laser centering devices for X-ray generators due to potential failure to comply with federal regulations.

    Product
    GE Optional Laser Centering Device X-ray generator.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-2941-2015·2015-08-19

    Janka Apricot Pierogi Recalled for Missing Yellow #5 Labeling

    Krusinskis Finest Meat Products is recalling Janka Fully Cooked Apricot Pierogi because Yellow #5 was not listed on the label.

    Product
    Janka Fully Cooked Apricot Pierogi Ingredients: DOUGH: Blended Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Potassium Bromate, Thiamine Mononitrate, Riboflavin), Water, Whole Milk, Eggs, Dried Potatoes (Color and Flavor Protected with Sodium Bisulfate, Citric Acid and B
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2953-2015·2015-08-19

    Chemi-source Recalls DHEA 25mg Capsules for Labeling Inaccuracy

    Chemi-source, Inc. is recalling DHEA 25mg capsules because they may contain more DHEA than the label claims.

    Product
    DHEA 25mg, 60 count, sku: #6-09492-41001-6, and 90 count, sku: #6-09492-41002-3; 12 bottles/case.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-2955-2015·2015-08-19

    Kraft American Singles cheese recalled due to plastic film contamination

    Kraft Heinz is recalling specific Kraft American Singles cheese products because they may contain thin strips of plastic film on the edges of the slices.

    Product
    Kraft American Singles white American Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and bl
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2949-2015·2015-08-19

    Mitsuwa Recalls Baked Seasoned Fish Products Due to Temperature Violation

    Mitsuwa Corporation is recalling specific baked seasoned fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Goby Okabe (Osakana Roll) Net Wt.: 65GR/2.29oz Ingredients: Goby, Sugar, Salt, Sorbitol, Monosodium Glutamate Keep Refrigerated SKU: 4 971455 081738 Product of Japan Exported By: KC Central Trading Co. Ltd. 4F 7-2 Irifune 3-Chome Chuo-Ku Tokyo 104-
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-2947-2015·2015-08-19

    Mitsuwa Recalls Baked Seasoned Sardine and Goby Products for Temperature Violation

    Mitsuwa Corporation is recalling three baked fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Sardine Okabe (Asuri Washi Shiokoki) Net Wt.: 70GR/2.47oz SKU: 4 971455 081714 Ingredients: Sardine, Salted Rice Malt, Sugar, Sorbitol, Monosodium Glutamate Keep Refrigerated Exported By: KC Central Trading Co. Ltd. 4F 7-2 Irifune 3-Chome Chuo-Ku Toky
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1320-2015·2015-08-19

    Biotene PBF Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene PBF toothpaste because wood fragments were found when the product was extruded.

    Product
    biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2015·2015-08-19

    Stryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement

    Stryker Howmedica Osteonics is recalling 26 Triathlon tibial inserts because one unit was found in a package labeled for a different catalog number.

    Product
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2376-2015·2015-08-19

    Biotronik Recalls Unapproved Pacemaker Programmer Software Versions

    Biotronik is recalling specific pacemaker programmer software versions because they are not approved for use in the United States.

    Product
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2351-2015·2015-08-19

    Remel Recalls PathoDx Strep B Grouping Latex Reagent

    Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    Product
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2375-2015·2015-08-19

    Advanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions

    Advanced Sterilization Products is recalling 1,465 STERRAD 100NX wall charts because they contain incorrect instructions regarding instrument tray wrapping.

    Product
    Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1319-2015·2015-08-19

    Biotene Sodium Fluoride Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    BIOTENE — BIOTENE (SODIUM FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2352-2015·2015-08-19

    Merit Medical Recalls ReSolve Locking Drainage Catheters Due to Labeling Discrepancy

    Merit Medical Systems is voluntarily recalling 950 ReSolve Locking Drainage Catheters because the unit labeling may not match the actual device in the package.

    Product
    ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2945-2015·2015-08-19

    Lee Egg Rolls Recalled for Undeclared Monosodium Glutamate

    LV Foods is recalling Lee Egg Rolls Vegetables and Textured Vegetable Protein due to undeclared monosodium glutamate (MSG). The product was distributed in California.

    Product
    Lee Egg Rolls Vegetables and Textured Vegetable Protein, Net Wt. 15lbs. 0 oz., Lee Egg Rolls Jacinto City, Texas 77029
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2948-2015·2015-08-19

    Mitsuwa Recalls Baked Sardine and Goby Products for Temperature Violations

    Mitsuwa Corporation is recalling three baked fish products because they were not kept refrigerated as required by their labels.

    Product
    Baked Seasoned Sardine Ambient Okabe (Iwashi Senbei) Net Wt.: 77GR/2.65oz Ingredients: Sardines, Sugar, Milk Protein Hydrolysate, Soy Sauce (Water, Soybean, Wheat, Salt), Sweet Cooking Wine, Sesame, Red Pepper, Monosodium Glutamate Keep Refrigerated Product of Japan
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-2954-2015·2015-08-19

    Kraft American Singles Cheese Recalled for Plastic Film Contamination

    Kraft Heinz is recalling Kraft American Singles cheese slices because some may contain thin strips of plastic film on the edges.

    Product
    Kraft American Singles Pasteurized prepared cheese products packaged clear plastic. Sold at retail as 1 lb. packages. Some products are only packaged in the clear plastic and some are packaged in the clear plastic with a blue label attached with white, black, and blue lettering.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1321-2015·2015-08-19

    Sensodyne Toothpaste Recalled for Wood Fragments

    GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product.

    Product
    SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1322-2015·2015-08-19

    Sensodyne Complete Protection Recalled for Wood Fragments

    GlaxoSmithKline is recalling Sensodyne Complete Protection toothpaste because wood fragments were found in the product. Consumers should stop using the affected tubes.

    Product
    SENSODYNE COMPLETE PROTECTION — SENSODYNE COMPLETE PROTECTION (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1317-2015·2015-08-19

    Biotene Gentle Mint Gel Recalled for Wood Fragments

    GlaxoSmithKline is recalling Biotene Gentle Mint Gel tubes because wood fragments were found in the product. Consumers should stop using the affected lots.

    Product
    biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1324-2015·2015-08-19

    Sensodyne Toothpaste Recalled Due to Wood Fragments

    GlaxoSmithKline is recalling 325,504 tubes of Sensodyne toothpaste because wood fragments were found when the product was extruded.

    Product
    SENSODYNE — SENSODYNE (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2015·2015-08-19

    Stryker Recalls Mispackaged Orthopedic Shoulder Trial Instruments

    Stryker is recalling 21 units of a shoulder trial instrument because the package contained the wrong part number.

    Product
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2379-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling 9 AngioJet SOLENT Dista Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and r
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2378-2015·2015-08-19

    Boston Scientific Recalls AngioJet Thrombectomy Sets Due to Incorrect Expiry Dates

    Boston Scientific is recalling 9 AngioJet SOLENT Omni Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing t
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2361-2015·2015-08-19

    Abbott Recalls i-Stat PT/INR Cartridges Due to Test Delays

    Abbott Point Of Care Inc. is recalling specific lots of i-Stat PT/INR Cartridges because they may generate excessive star outs, potentially delaying patient results.

    Product
    i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2377-2015·2015-08-19

    Boston Scientific Recalls AngioJet Spiroflex Thrombectomy Sets Due to Incorrect Expiry Date

    Boston Scientific is recalling nine AngioJet Spiroflex Thrombectomy Sets because they were labeled with an incorrect use-by date of December 2015 instead of November 2015.

    Product
    AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking ap
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Food)·F-2951-2015·2015-08-19

    Mason Vitamins Recalls Mislabeled Coenzyme Q-10 50 mg Softgels

    Mason Vitamins, Inc. is recalling 13,027 bottles of Coenzyme Q-10 50 mg softgels because some bottles were mislabeled with the wrong dosage.

    Product
    Coenzyme Q-10 50 mg label reads in part, "***Major***CO Q-10 50 MG***For healthy HEART & IMMUNE function***Promotes ENERGY in all Body Cells***Dietary Supplement 30 SOFTGELS***."
    Category
    Food
    Distribution
    31 states
  • SevereNHTSA·15V527000·2015-08-18

    Starcraft Transit Bus Recall for Fire Risk from Wiring

    Forest River is recalling 32 Starcraft transit buses due to an improperly routed cable that may cause an electrical short and fire.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALL STAR XL, XLT, ALL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V529000·2015-08-18

    E-One Emergency Vehicles Recalled for Lighting and Siren Safety Defect

    E-One is recalling 2013-2016 Pumpers, Tankers, and Rescue vehicles because the master power switch does not link to the start circuit, allowing operation without lights or sirens.

    Product
    E-ONE — E-ONE RESCUE, TANKER, PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V526000·2015-08-18

    Turtle Top Transit Buses Recalled for Back-Up Camera Image Reversal

    Turtle Top is recalling certain 2014-2015 transit buses because the back-up camera system may display reversed images, increasing the risk of a crash.

    Product
    TURTLE TOP — TURTLE TOP VANTERRA, ODYSSEY, ODYSSEY XLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15218·2015-08-18

    Rite Aid Recalls Outdoor Dining Sets Due to Fall Hazard

    Rite Aid is recalling about 13,000 outdoor dining sets because chair arms and legs can bend, causing users to fall and potentially be injured.

    Product
    Outdoor Dining Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V525000·2015-08-18

    Starcraft Transit Buses Recalled for Potential Fuel Injector Failure

    Forest River is recalling 2013-2014 Starcraft All Star XL and 2013 XLT transit buses because fuel injectors may fail, potentially causing engine stalls and increasing crash risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS ALL STAR XL, XLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V528000·2015-08-18

    Mack Granite Trucks Recalled for Air Brake Reservoir Volume Defect

    Mack is recalling 2011-2016 Granite trucks because an air brake reservoir may have insufficient volume, potentially affecting braking performance and increasing crash risk.

    Product
    MACK — MACK GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15219·2015-08-18

    Merck Recalls Temodar and Temozolomide Bottles with Cracked Caps

    Merck is recalling approximately 276,000 bottles of Temodar and Temozolomide capsules because cracked caps may fail to keep young children from accessing the medication.

    Product
    Bottles with cracked caps containing Temodar® (Temozolomide) and Temozolomide (generic) capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V523000·2015-08-17

    Volvo Recalls 2012-2016 VAH Trucks for Steering Drag Link Defect

    Volvo is recalling 2012-2016 VAH trucks because a damaged steering component may corrode, potentially causing loss of steering and increasing crash risk.

    Product
    VOLVO — VOLVO VAH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·112-2015·2015-08-17

    Givaudan Recalls Beef Tallow Products Produced Without Import Inspection

    Givaudan Flavors Corporation is recalling approximately 3,950 pounds of beef tallow products produced in Australia that were not inspected at the U.S. point of entry.

    Product
    Givaudan Flavors Corporation Recalls Beef Tallow Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V521000·2015-08-17

    Mack Pinnacle Trucks Recalled for Brake Chamber Mounting Defect

    Mack is recalling 2013-2015 Pinnacle trucks because incorrectly mounted brake chambers may contaminate calipers, increasing stopping distance and crash risk.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V524000·2015-08-17

    Volvo Recalls 2012-2015 VNL and VNM Trucks for Brake Handle Defect

    Volvo is recalling 2012-2015 VNL and VNM trucks because the trailer hand brake handle may not return to the off position, potentially causing wheel overheating, fire, or tire blowout.

    Product
    VOLVO — VOLVO VNM, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V522000·2015-08-17

    Mack Trucks Recall Chassis Harness and Air Line Clipping Defect

    Mack Trucks is recalling specific model year 2009-2016 Granite, Titan, and Pinnacle trucks because chassis harness and air lines may not be properly clipped, risking driveline entanglement.

    Product
    MACK — MACK GRANITE (GU), TITAN, PINNACLE (CHU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V520000·2015-08-17

    BMW Recalls 3-Series Vehicles Due to Inoperative Side Marker Lights

    BMW is recalling certain 2012-2015 3-Series vehicles because software may cause front side marker lights to fail, reducing visibility at night.

    Product
    BMW — BMW 328XI, 328XD, 328I, 328D
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E065000·2015-08-14

    Marmon-Herrington Recalls Drive Axles with Improperly Tightened Hex Nuts

    Marmon-Herrington is recalling specific drive axles manufactured between July 2014 and July 2015 because hex nuts may not be properly tightened, posing a crash risk.

    Product
    POWER TRAIN:AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·111-2015·2015-08-14

    Pleasant House Bakery Recalls Steak and Chicken Pies for Undeclared Allergens

    Pleasant House Bakery is recalling steak and chicken pies distributed without inspection and containing undeclared eggs, milk, and wheat.

    Product
    Pleasant House Bakery Recalls Steak and Chicken Products Distributed Without the Benefit of Inspection and Due to Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V517000·2015-08-14

    Chrysler Recalls 2014-2015 Ram 1500 Diesel Trucks for Fire Risk

    Chrysler is recalling 2014-2015 Ram 1500 diesel trucks because a battery harness may rub against the frame, causing an electrical short that could lead to stalling or fire.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V519000·2015-08-14

    GM Recalls Vehicles for Headlamp Driver Module Overheating Defect

    General Motors is recalling specific 2005-2009 models because the headlamp driver module may overheat and fail, causing lights to stop working.

    Product
    BUICK — BUICK, SAAB, PONTIAC RAINIER, LACROSSE, 9-7X, GRAND PRIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15746·2015-08-14

    Trane and American Standard Recall Accessory Heaters Due to Fire Hazard

    Trane and American Standard are recalling specific accessory heaters installed in air handlers due to a fire hazard caused by overheating.

    Product
    Accessory heaters installed in TAM7 and TAM8 air handlers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V512000·2015-08-13

    Terex Recalls 2013-2015 Digger Derrick and Aerial Devices Trucks

    Terex is recalling 386 model year 2013-2015 Digger Derrick and Aerial Devices trucks because vertical cylinders may drift when loaded, risking platform falls.

    Product
    TEREX — TEREX DIGGER DERRICK, AERIAL DEVICES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V516000·2015-08-13

    Pierce Emergency Vehicles Recalled for Driveshaft Defect

    Pierce is recalling 2014-2015 emergency vehicles because a driveshaft may bend or twist, potentially causing loss of drive and road hazards.

    Product
    PIERCE — PIERCE ENFORCER, VELOCITY, DASH CF, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·15213·2015-08-13

    Ambient Weather Recalls Radios Due to Fire Hazard

    Ambient Weather is recalling about 12,500 weather radios because the AC power adapter can overheat, posing a fire hazard. Consumers should stop using the radios and contact the company for a free replacement adapter.

    Product
    Ambient Weather radios
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·110-2015·2015-08-13

    Kapowsin Meats Recalls Pork Products Due to Salmonella Contamination

    Kapowsin Meats is recalling approximately 116,262 pounds of whole hogs for barbeque due to possible Salmonella contamination linked to 134 illnesses in Washington.

    Product
    Kapowsin Meats Recalls Pork Product Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·15V515000·2015-08-13

    Toyota Recalls 4Runners Due to Accessory Exhaust Tip Burn Risk

    Southeast Toyota Distributors is recalling 2010-2015 Toyota 4Runners because accessory exhaust tips may contact people and cause burns.

    Product
    TOYOTA — TOYOTA 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V513000·2015-08-13

    AEV Trauma Hawk Recalled for Reversed Backup Camera Images

    Halcore Group is recalling 2014-2015 AEV Trauma Hawk emergency vehicles because the backup camera may display reversed images, increasing crash risk.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2914-2015·2015-08-12

    Rocky Mountain Foods Recalls Macadamia Nut Mixes for Salmonella Risk

    Rocky Mountain Foods is recalling Macadamia Nuts and mixes containing Macadamia Nuts due to possible Salmonella contamination. The recall covers products distributed between March 19, 2015, and June 5, 2015.

    Product
    Free Range Snack Co. Island Fruit and Nut Trail Mix, Net We 16 oz (454g)
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2915-2015·2015-08-12

    Rocky Mountain Foods Recalls Macadamia Nuts for Salmonella Risk

    Rocky Mountain Foods is recalling raw macadamia nuts and mixes due to possible Salmonella contamination.

    Product
    Free Range Snack Co. Raw Macadamia Nuts, Net Wt. 15 LB. (6.80 kg), Ingredients: macadamia Nuts
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2908-2015·2015-08-12

    Whole Foods Market Recalls Blackberry Pies Due to Undeclared Egg

    Whole Foods Market is recalling specific blackberry pies in Texas, Oklahoma, and Louisiana because they contain undeclared egg, a major food allergen.

    Product
    Blackberry Pie 9 Inch NET WT. 2lb 4oz (1021g) and Blackberry Pie Half NET WT. 1lb 1oz (482g) and individual slices.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-2906-2015·2015-08-12

    Whole Food Market Recalls Peach Pies Due to Undeclared Egg

    Whole Food Market is recalling 11 units of peach pies in Texas, Oklahoma, and Louisiana because they contain undeclared egg.

    Product
    Peach Pie 9 Inch NET WT. 2lb 4oz (1021g) and Peach Pie Half NET WT. 1lb 1oz (482g) and individual slices
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-2936-2015·2015-08-12

    Supervalu Danish Rolls Recalled for Undeclared Milk Allergen

    Supervalu, Inc. is recalling Danish Rolls that may contain undeclared milk. The product was distributed in Minnesota and Illinois.

    Product
    Danish Rolls, 4 Ct., Net Wt. 13oz. in clear plastic clam shell.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-2911-2015·2015-08-12

    Osamu Recalls Raw Frozen Saku Tuna Due to Salmonella Risk

    Osamu Corporation is recalling raw frozen saku tuna from Indonesia due to potential Salmonella contamination. The product was distributed to 15 U.S. states and D.C.

    Product
    Raw Frozen Sliced Saku Tuna Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-2916-2015·2015-08-12

    Whole Foods Market Recalls Raw Macadamia Nuts Due to Salmonella

    Whole Foods Market is recalling raw macadamia nuts found positive for Salmonella. The product was distributed in 12 states.

    Product
    Whole Foods Market Raw Macadamia Nuts NET WT 11 oz (312g). UPC: 0-76958-62059-1, Distributed by Whole Foods Market Austin, TX 78703
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-2907-2015·2015-08-12

    Whole Food Market Recalls Cherry Pies Due to Undeclared Egg

    Whole Food Market is recalling specific cherry pies because they contain undeclared egg. The recall covers products sold in Texas, Oklahoma, and Louisiana.

    Product
    Cherry Pie 9 Inch NET WT. 2lb 4oz (1021g) and Cherry Pie Half NET WT. 1lb 1oz (482g) and individual slices
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2326-2015·2015-08-12

    Aesculap S4C Occiput Torque Wrench Recalled Due to Reassembly Defect

    Aesculap is recalling 10 S4C Occiput Torque Wrenches because improper reassembly after reprocessing caused a screw to break during implantation.

    Product
    S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipital plate/transverse connector and other connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2943-2015·2015-08-12

    Anabolic Science Labs Recalls Slim X Lean Hour Energy Drink

    Anabolic Science Labs is recalling Slim X Lean Hour 12+ Hour Energy products due to undeclared synthetic hormone ingredients.

    Product
    "***SLIM X LEAN HOUR 12+ HOUR ENERGY***PRODUCT ID: ASL-SXL-03***Manufactured for: ASL ANABOLIC SCIENCE LABS WINTER PARK, FL 32789***
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2909-2015·2015-08-12

    Osamu Recalls Frozen Tuna Chunks Due to Potential Salmonella Contamination

    Osamu Corporation is recalling raw frozen tuna chunks from Indonesia due to potential Salmonella contamination. The recall covers 625 cases distributed across 15 U.S. states and D.C.

    Product
    Raw Frozen Tuna Chunks Product of Indonesia. The bulk frozen tuna products can be identified from the Purchase Order Number (PO#) printed on each product carton box end panel.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-2319-2015·2015-08-12

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Separation

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because the tips may split or separate, potentially causing loss of function or complications.

    Product
    Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide

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