The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
305
High
392
Moderate
171
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 29% are Severe.

301–400 of 1035

  • HighFDA (Devices)·Z-0284-2017·2016-10-26

    Windstone Medical Packaging Recalls Virginia Custom Pack Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling Virginia Custom Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.

    Product
    Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2017·2016-10-26

    Windstone Medical Custom Surgery Kits Recalled for Sterility Compromise

    Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising sterility.

    Product
    Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0228-2017·2016-10-26

    National Foods Packaging Recalls Low Sodium Chicken Base Due to Lead

    National Foods Packaging Inc is recalling 2,000 pounds of Low Sodium Chicken Base because a spice ingredient contained elevated levels of lead.

    Product
    National Foods Packaging Low Sodium Chicken Base in 50 lb white poly-lined paper bags
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0227-2017·2016-10-26

    National Foods Packaging Recalls Chicken Base Due to Lead Contamination

    National Foods Packaging Inc is recalling 8,825 lb of Chicken Base because a spice ingredient contained elevated levels of lead. The product was distributed in Indiana, Texas, and Virginia.

    Product
    National Foods Packaging Chicken Base in 25 lb white poly-lined paper bags
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0133-2017·2016-10-26

    ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Crease

    ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0091-2017·2016-10-26

    Triceutical Recalls Super Natural Children's Growth Formula Due to Manufacturing Issues

    Triceutical Inc. is recalling Super Natural Children's Growth Formula dietary supplements because they were not produced according to good manufacturing practices.

    Product
    Super Natural Children's Growth Formula Dietary Supplement, 90 Tablets, Manufactured for GW Biotech Greenwood Biotech, LLC New York. Made in USA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0096-2017·2016-10-26

    Triceutical Recalls Blue Rock Holistics Super Shield Dietary Supplement

    Triceutical Inc. is recalling Blue Rock Holistics Super Shield dietary supplements due to a lack of good manufacturing practices.

    Product
    DIETARY SUPPLEMENT BLUE ROCK HOLISTICS SUPER SHIELD, 90 Vegetable Capsules, Distributed by: Holistic Blends, Inc. 925 State Fair Blvd Syracuse, NY 13209 USA.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0089-2017·2016-10-26

    Triceutical Recalls Premium Protein III Supplements for Manufacturing Violations

    Triceutical Inc. is recalling Premium Protein III Nutritional Supplements because they were not manufactured according to good manufacturing practices.

    Product
    Premium Protein III Nutritional Supplement, NET WT 16 OZ. (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219. Made in USA
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0164-2017·2016-10-26

    Entenmann's Little Bites Chocolate Chip Muffins Recalled for Plastic Presence

    BIMBO Bakeries USA Inc. is recalling Entenmann's Little Bites Chocolate Chip Muffins due to the presence of plastic in the product.

    Product
    Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches; Net Wt. 1 lb. 0.5 OZ. ; Bimbo Bakeries USA, Inc.; PO #976, Horsham, PA 19044. Best By: October 8, 2016/3098; UPC: 7203002111; Entenmann's Little Bites Chocolate Chip Muffins; 20 Muffins, 5 Pouches; Net Wt. 8.25 OZ.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0289-2017·2016-10-26

    US Endoscopy Recalls Vari-Safe Injection Needles Due to Incorrect Distribution

    US Endoscopy is voluntarily recalling one lot of Vari-Safe Injection Needles because the lot was incorrectly distributed with different internal catheter components.

    Product
    Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0090-2017·2016-10-26

    Ortho-Clinical VITROS Chemistry LAC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides per sales unit) and 815 0112 (90 slides per sales unit), Unique Device Identifier Nos. 10758750004911 and 10758750004454, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0167-2017·2016-10-26

    Nature's One Organic PediaSmart Beverage Recalled for Incorrect Scoop Size

    Nature's One is recalling Organic PediaSmart Dairy Vanilla beverage cans because they contain a scoop that provides only 60% of the intended nutrition.

    Product
    Nature's One, Organic PediaSmart¿ Dairy Vanilla complete nutrition beverage for kids 1 to 13 years NET WT 12.7 oz (360 G) can Contains: milk, soy & coconut UPC 7 16514 88101 0 Manufactured for: Natures One, 8754 Cotter Street, Lewis Center, OH 43035
    Category
    Food
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0129-2017·2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Creases

    ConMed is recalling CORE Suction Irrigation Handpieces because creases in the packaging seal may create open channels that compromise the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0123-2017·2016-10-26

    Randox Lipase Test System Recalled for Carryover Interference

    Randox Laboratories is recalling 18 units of Lipase test kits due to carryover interference when run near LDL or Triglycerides assays.

    Product
    Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0168-2017·2016-10-26

    Ozturk Gardens Recalls Black Bean and Corn Salsa Due to Elevated pH

    Ozturk Gardens is recalling 10 cases of Dr. O'z SALSA Black Bean and Corn due to elevated pH levels. The product was distributed in Oklahoma.

    Product
    "Dr. O'z SALSA Black Bean and Corn Made with my Mom's secret recipe! Stir Before Serving Net Wt. 16oz (454g) All Natural No Preservatives www.ozturkfoods.com Distributed by Ozturk Foods 28872 S. Big Hollow Rd. Park Hill OK 74451 Refrigerate After Opening"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0134-2017·2016-10-26

    ConMed CORE Trumpet Handpiece Recalled for Packaging Seal Crease

    ConMed is recalling CORE Trumpet Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.

    Product
    CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2017·2016-10-26

    Zimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error

    Zimmer Biomet is recalling five Vanguard Distal Femoral Augments because the product inside the carton does not match the label. The mismatched size is easily identified during surgery.

    Product
    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity. …
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0132-2017·2016-10-26

    ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Defect

    ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may compromise the product's sterility.

    Product
    CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2017·2016-10-26

    Hand Biomechanics Lab Recalls Agee WristJack Fracture Reduction Systems

    Hand Biomechanics Lab Inc is recalling 65 Agee WristJack Fracture Reduction Systems because a molded beam is slightly larger than optimal, which may make surgical adjustments difficult.

    Product
    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0166-2017·2016-10-26

    Entenmann's Little Bites Fudge Brownies Recalled Due to Plastic Presence

    BIMBO Bakeries USA is recalling Entenmann's Little Bites Fudge Brownies because plastic was found in the muffins and brownies.

    Product
    Entenmann's Little Bites Fudge Brownies - 20 muffins, 5 Pouches; Net Wt. 9.75 OZ.; Bimbo Bakeries USA, Inc., Horsham, PA 19044; Best By: October 8, 2016/3098; UPC: 7203001342
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0112-2017·2016-10-26

    Stryker Recalls Sagittal Blades Due to Potential Sterile Barrier Breach

    Stryker Instruments is voluntarily recalling 225 Sagittal Blades due to a potential sterile barrier breach in the packaging.

    Product
    Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2017·2016-10-26

    Ortho VITROS URIC Slides Recalled Due to NAC Interference

    Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.

    Product
    VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0128-2017·2016-10-26

    BD Biosciences Recalls Contaminated CD79b PE Antibody Reagent

    Becton, Dickinson and Company is recalling 14 units of CD79b PE antibody reagent due to contamination with a FITC conjugate of unknown specificity.

    Product
    CD79b PE (ASR) , Catalog number 335816 ; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 3640 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0106-2017·2016-10-26

    Triceutical Inc. Recalls Eagle Lecithin Soft Gels for Manufacturing Violations

    Triceutical Inc. is recalling Eagle Lecithin soft gels because the company failed to follow good manufacturing practices. The recall covers 1,008 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Eagle Lecithin soft gels
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0190-2017·2016-10-26

    Adwe Prenatal Vitamin Recalled for Folic Acid Potency Concerns

    DNE Nutraceuticals Inc. is recalling Adwe Prenatal tablets due to a concern regarding the potency of folic acid. The recall affects 1,200 bottles distributed in New York.

    Product
    Adwe Naturals Prenatal Vitamin Manufactured for: Adwe Laboratories 1274 49 Street Brooklyn, NY 11219 UPC 040168805079
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0130-2017·2016-10-26

    ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects

    ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.

    Product
    CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2017·2016-10-26

    Ortho VITROS Chemistry GLU Slides Recalled for Potential Assay Interference

    Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.

    Product
    VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0226-2017·2016-10-26

    Hillcrest Farms Poultry Gravy Mix Recalled for Lead Contamination

    National Foods Packaging Inc is recalling Hillcrest Farms Poultry Gravy Mix because a spice ingredient was found to contain elevated levels of lead.

    Product
    Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined bags
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2017·2016-10-26

    King Henry's Recalls Gummy Frogs Due to Undeclared Colors

    King Henry's is recalling Gummy Frogs because they may contain undeclared colors FD&C Yellow #6 and Red #40.

    Product
    Gummy Frogs, 2.5oz, UPC 61054635210
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0093-2017·2016-10-26

    Tearscience Recalls LipiFlow Thermal Pulsation System Activators Due to Error Condition

    Tearscience, Inc. is recalling 1,200 LipiFlow Thermal Pulsation System Activators because the device may automatically stop treatment during patient use.

    Product
    LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic…
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Food)·F-0188-2017·2016-10-26

    King Henry's Gummy Frogs Recalled for Undeclared Colors

    King Henry's is recalling Gummy Frogs because they may contain undeclared food dyes. Consumers should stop eating the product.

    Product
    Gummy Frogs, 6oz, UPC 6105465200, 61054645500
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0165-2017·2016-10-26

    Entenmann's Little Bites Variety Recalled Due to Plastic Presence

    BIMBO Bakeries USA Inc. is recalling 45,600 boxes of Entenmann's Little Bites Variety due to the presence of plastic in the muffins and brownies.

    Product
    Entenmann's Little Bites Variety - 20 pouches labeled for resale 10 Chocolate Chip; 5 Blueberry; 5 Fudge Brownie; Net Wt 2 lbs.; Distributed by: Entenmann's Inc., General Offices, PO #976, Horsham, PA 19044. Best by: September 24, 2016/ 3098; UPC:7203001799
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0094-2017·2016-10-26

    Triceutical Recalls Joint Optima Dietary Supplements for Manufacturing Violations

    Triceutical Inc. is recalling Joint Optima dietary supplements because they were not produced under good manufacturing practices. The recall covers 1,500 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Optima Rebuilds, Lubricates and Soothes Joints, Triple Strength, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0095-2017·2016-10-26

    Triceutical Recalls Joint Lubrica Rebuilds Dietary Supplements for Manufacturing Issues

    Triceutical Inc. is recalling Joint Lubrica Rebuilds dietary supplements due to a lack of good manufacturing practices. The product was distributed in Florida, New York, Pennsylvania, and China.

    Product
    Joint Lubrica Rebuilds, 120 Capsules, Dietary Supplement, Distributed by: GW Biotech Greenwood Biotech, LLC Staten Island, NY 10305. Made in USA.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0090-2017·2016-10-26

    Triceutical Recalls Hyaluronic Acid Supplements Due to Manufacturing Deficiencies

    Triceutical Inc. is recalling all lots of Byron J. Richards Hyaluronic Acid dietary supplements due to a lack of good manufacturing practices.

    Product
    Byron J. Richards Wellness resources Hyaluronic Acid Dietary Supplement, 60 Capsules, Distributed by Wellness Resources, Inc. 7155 Amundson Avenue, Minneapolis, MN 55439 800-717-WELL.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0111-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling specific lots of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7658-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0110-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,556 bottles of Paricalcitol Capsules because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7657-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0113-2017·2016-10-26

    Osteogenics Recalls Cytoplast Membrane Due to Packaging Error

    Osteogenics Biomedical, Inc. is recalling 32 boxes of Cytoplast Titanium-Reinforced Posterior Singles Membrane because the device may be packaged in the wrong product box.

    Product
    Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-0088-2017·2016-10-26

    Triceutical Recalls Premium Protein III Supplement for Manufacturing Deficiencies

    Triceutical Inc. is recalling Premium Protein III for kids due to a lack of good manufacturing practices. The recall covers 693 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    PREMIUM PROTEIN III For kids Nutritional Supplement, NET WT 16 OZ (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219. Made in USA
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0097-2017·2016-10-26

    Triceutical Recalls Super Lecithin Complex Soft Gels for Manufacturing Issues

    Triceutical Inc. is recalling Super Lecithin Complex soft gels due to a lack of good manufacturing practices. The recall covers 1,450 bottles distributed in Florida, New York, Pennsylvania, and China.

    Product
    Super Lecithin Complex soft gels
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-0109-2017·2016-10-26

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 32,015 bottles of Paricalcitol Capsules, 1 mcg, because stability testing revealed out-of-specification impurities.

    Product
    PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E079000·2016-10-25

    Atwood Recalls Left Side Seat Adjusters for Crash Safety Non-Compliance

    Atwood Mobile Products is recalling specific left side seat adjusters used in vehicle seat belts because they may allow seats to move during a crash, increasing injury risk.

    Product
    SEAT BELTS:FRONT:ANCHORAGE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·100-2016·2016-10-25

    Crider Recalls Canned Organic Roasted Chicken Breast Due to Foreign Matter

    Crider Inc. is recalling approximately 5,610 pounds of canned Organic Roasted Chicken Breast due to possible foreign matter contamination.

    Product
    Crider, Inc. — Crider Inc. Recalls Canned Organic Roasted Chicken Breast Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16E080000·2016-10-25

    Ivolution Recalls JX-SKY Helmets Due to Crash Safety Non-Compliance

    Ivolution Sports is recalling specific JX-SKY helmets because a metal screw prevents a detachable feature from releasing during a crash, increasing neck injury risk.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V772000·2016-10-24

    Jayco Recalls 2017 Eagle Fifth Wheel Trailers for Axle Defect

    Jayco is recalling specific 2017 Eagle fifth wheel trailers due to axles with insufficient load capacity, which may lead to tire failure and increased crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V769000·2016-10-24

    ARBOC Spirit of Liberty Recall for Engine Run Lockout Wiring Defect

    ARBOC is recalling 2016 Spirit of Liberty vehicles because improper wiring may allow the engine to start while a mechanic is working on it, posing a risk of injury or death.

    Product
    ARBOC — ARBOC SPIRIT OF LIBERTY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V775000·2016-10-24

    Toyota Recalls 2016 Highlanders Due to Brake Fluid Sensor Wiring Issue

    Toyota is recalling 7,056 model year 2016 Highlanders because the brake fluid level sensor may not be connected to the wire harness, potentially decreasing braking performance.

    Product
    TOYOTA — TOYOTA HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·099-2016·2016-10-21

    St. Clair Foods Recalls Chicken and Dumplings for Undeclared Milk Allergen

    St. Clair Foods is recalling approximately 26,800 pounds of chicken and dumplings due to misbranding and an undeclared milk allergen. The products were distributed to food service warehouses in six states.

    Product
    St. Clair Foods Inc. — St. Clair Foods, Inc. Recalls Poultry Products Due To Misbranding And An Undeclared Allergen
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·16V765000·2016-10-21

    Navistar Recalls School Buses with Defective Wheelchair Lifts

    Navistar is recalling certain 2015-2017 IC Bus school buses equipped with specific Ricon wheelchair lifts. The defect may cause the lift platform to fall out of the vehicle, increasing injury risk.

    Product
    IC BUS — IC BUS RESB, CESB, CASB, AE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V764000·2016-10-21

    Kaufman Recalls 2015-2016 Mini Car Haulers Due to Spring Defect

    Kaufman is recalling 2015-2016 Mini Car Haulers because a spring eye may break, allowing the axle to slide and potentially causing a crash.

    Product
    KAUFMAN — KAUFMAN MINI CAR HAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V766000·2016-10-21

    Navistar Recalls 2016 IC Bus RECB Models Due to Wheelchair Lift Defect

    Navistar is recalling 2016 IC Bus RECB transit buses equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure operators.

    Product
    IC BUS — IC BUS RECB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V768000·2016-10-21

    Newmar Recalls 2017 Motorhomes Due to Hydraulic Step Retraction Risk

    Newmar is recalling 2017 King Aire, Essex, and London Aire motorhomes because the hydraulic entry step controller may allow steps to retract unexpectedly, increasing the risk of injury.

    Product
    NEWMAR — NEWMAR LONDON AIRE, KING AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·098-2016·2016-10-21

    Brookwood Farms Recalls Pulled Pork Due To Undeclared Soy Allergen

    Brookwood Farms is recalling 126,570 pounds of pulled pork products because they contain soy, an undeclared allergen. No illnesses have been reported.

    Product
    Brookwood Farms — Brookwood Farms, Inc. Recalls Pulled Pork Products Due To Misbranding And An Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V767000·2016-10-21

    KME Predator Aerial Vehicles Recalled for Water Way Trolley Separation Risk

    KME is recalling certain Predator aerial emergency vehicles because the water way trolley could separate from the ladder, posing a falling object hazard.

    Product
    KME — KME PREDATOR SS AERIAL, PREDATOR AERIAL, PREDATOR PANTHER AERIAL, PREDATOR TDA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17704·2016-10-20

    Summer Classics Recalls Swivel Rocking Lounge Chairs Due to Fall Hazard

    Summer Classics is recalling about 800 swivel rocking lounge chairs because the seat bucket can break away from the base, posing a fall hazard. No injuries have been reported.

    Product
    Swivel rocking lounge chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V761000·2016-10-20

    Entegra Recalls 2016-2017 Motorhomes Due to Flammable Mattress

    Entegra is recalling 2016-2017 Cornerstone and Anthem motorhomes because the Tempurpedic Sealy Mattress may burn quickly, violating federal flammability standards.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V760000·2016-10-20

    Mercedes-Benz Recalls S-Class Vehicles for Headlight Adjustment Defect

    Mercedes-Benz is recalling 996 S-Class vehicles because improperly adjusted low-beam headlights may reduce driver visibility and increase crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, S65 AMG, AMG S65, S550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17018·2016-10-20

    Cabela's Recalls Commercial Food Dehydrators Due to Fire Hazard

    Cabela's is recalling commercial food dehydrators because defective wiring can cause heat build-up and fire. No injuries have been reported.

    Product
    Cabela's food dehydrators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V762000·2016-10-20

    Forest River Cedar Creek Recalled for Incorrect Axle Capacity Ratings

    Forest River is recalling 2017 Cedar Creek trailers because axles were misidentified as having a 7,000-pound capacity when they are only rated for 6,000 pounds.

    Product
    FOREST RIVER — FOREST RIVER CEDAR CREEK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17019·2016-10-20

    Makita Recalls 5057KB Circular Saws Due to Laceration Hazard

    Makita is recalling about 450 5057KB circular saws because the lower blade guard can malfunction and expose the blade, posing a laceration risk.

    Product
    Circular saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0006-2017·2016-10-19

    Uncle Buck's Maple Nut Candy Recalled for Undeclared Peanut Allergen

    Rucker's Wholesale & Service Co. is recalling Uncle Buck's Maple Nut candy because the label fails to list peanuts, a major allergen, as an ingredient.

    Product
    Uncle Buck's Maple Nut candy packaged in a clear plastic 2.7 oz. bag with attached green, orange, and white label with Organe and black writing.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0020-2017·2016-10-19

    Oasis Dietary Supplement Capsules Recalled for Unapproved Active Ingredients

    Bee Xtreme LLC is recalling Oasis Dietary Supplement Capsules because FDA analysis found the products contain sibutramine and phenolphthalein without an approved NDA or ANDA.

    Product
    Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Food)·F-0087-2017·2016-10-19

    NatureBox Dark Cocoa Nom Noms Recalled for Undeclared Peanut Allergen

    NatureBox is recalling Dark Cocoa Nom Noms because some bags may contain peanut butter but do not list peanuts on the label.

    Product
    Dark Cocoa Nom Noms 4.5oz. (128g) UPC: 8 54557 00533 5 Lot 16083 Product is shipped directly to customers per individual order or to corporate customers in 20 x 4.5 oz. bags cases. Ingredients: Rolled Oats, Almonds. For address freshness (Grape juice, rice dextrin)…
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0083-2017·2016-10-19

    Errington Cheese Recalled Due to E. Coli O157 Detection

    Tomales BayFoods is recalling Corra Lin Sheep Milk Cheese because Food Standards Scotland detected E. Coli O157 in the product.

    Product
    Corra Lin Sheep Milk Cheese; Raw Sheep's Milk, Starter and Ripening Cultures, Salt and Rennet Sold in wheels, wt. range of 13.24 to 15.90 lb. Neal's Yard Dairy, London Neal's Yard Dairy - exporter Manufactured by Errington Cheese Ltd., South Lanarkshire, United Kingdom.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0019-2017·2016-10-19

    La' Trim Plus Capsules Recalled for Unapproved Active Ingredients

    Bee Xtreme LLC is recalling La' Trim Plus dietary supplements because FDA analysis found unapproved drugs sibutramine and phenolphthalein.

    Product
    La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0094-2017·2016-10-19

    B. Braun Recalls 5% Dextrose Injection Due to Fungal Contamination

    B. Braun Medical Inc. is recalling 57,408 units of 5% Dextrose Injection USP due to non-sterility caused by fungal contamination from leaking containers.

    Product
    5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0047-2017·2016-10-19

    Quaker Quinoa Granola Bars Recalled Due to Listeria Risk

    The Quaker Oats Company is recalling Quaker Quinoa Granola Bars because sunflower kernels used in their production were linked to a Listeria monocytogenes recall.

    Product
    Quaker Quinoa Granola Bars, chocolate nut medley packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00243 8
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0051-2017·2016-10-19

    FDA Recalls Bikaji Chowpati Bhelpuri Due to Salmonella Contamination

    Krishna Food Corp is recalling Bikaji Chowpati Bhelpuri because FDA testing found Salmonella contamination. The product was distributed in New Jersey, New York, and Pennsylvania.

    Product
    BIKAJI Chowpati BHELPURI, NET WT : 300 g [ 10.58 OZ ], Item No: B022, PRODUCT OF INDIA
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Drugs)·D-0022-2017·2016-10-19

    Diocto Liquid Stool Softener Recalled for Microbial Contamination

    The Harvard Drug Group is recalling Diocto Liquid stool softener bottles due to positive findings of Burkholderia cepacia contamination.

    Product
    Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0021-2017·2016-10-19

    Jenesis Dietary Supplement Capsules Recalled for Unapproved Ingredients

    Bee Xtreme is recalling Jenesis Dietary Supplement Capsules because FDA analysis found unapproved ingredients sibutramine and phenolphthalein.

    Product
    Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Food)·F-0048-2017·2016-10-19

    Quaker Quinoa Granola Bars Recalled Due to Listeria Risk

    The Quaker Oats Company is recalling Quaker quinoa granola bars because they were made with sunflower kernels contaminated with Listeria monocytogenes.

    Product
    Quaker quinoa granola bars, yogurt fruit and nut flavor packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00195 0
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2017·2016-10-19

    Pharmedium Recalls Heparin Sodium Syringes Due to Subpotency and Stability Concerns

    Pharmedium Services, LLC is recalling 350 syringes of Heparin Sodium Injection USP because confirmed subpotency and stability data do not support the expiry date.

    Product
    HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0016-2017·2016-10-19

    Leiter's Compounding Recalls Moxifloxacin Intravitreal Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Moxifloxacin intravitreal injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0007-2017·2016-10-19

    Cabela's Maple Nut Candies Recalled for Undeclared Peanut Allergen

    Rucker's Wholesale & Service Co. is recalling Cabela's Maple Nut candies because the label fails to list peanuts, a major allergen.

    Product
    Cabela's classic candies Maple nut packaged in 2.7 oz. clear plast ice bag with brown label attached with brown lettering.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0049-2017·2016-10-19

    Nature's Power Solutions Acidophilus Blend Recalled for Undeclared Milk

    Complete Packaging & Manufacturing is recalling Nature's Power Solutions Acidophilus Blend dietary supplements because they contain undeclared milk, a major food allergen.

    Product
    Dietary Supplement Acidophilus Blend, 90 capsules, Product No. E-420, packaged in 225cc HDPE white bottle, room temp, sold individually
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0055-2017·2016-10-19

    Publix Maple Walnut Strip Danish Recalled for Metal Shavings

    Gold Standard Baking is recalling Publix Maple Walnut Strip Danishes due to the presence of small metal shavings.

    Product
    Publix Maple Walnut Strip Danish | Count, 1 | NET WT 14.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0034-2017·2016-10-19

    Pharmedium Recalls Fentanyl Citrate Injection Due to Subpotency and Stability Issues

    Pharmedium Services, LLC is recalling specific lots of fentanyl citrate injection because confirmed subpotency and stability data do not support the expiry date.

    Product
    fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0096-2017·2016-10-19

    Hospira Recalls Marcaine Injection Due to Sterility and Potency Issues

    Hospira is recalling 15 vials of Marcaine 0.25% injection because a glass defect allowed water to enter, compromising sterility and reducing drug potency.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0011-2017·2016-10-19

    Leiter's Compounding Recalls Brilliant Blue G Injection Due to Sterility Concerns

    Leiter's Compounding is recalling Brilliant Blue G injections because they were produced using recalled filters, raising concerns about sterility.

    Product
    Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
    Category
    Drug
    Distribution
    Distributed nationwide

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