The Recall Desk

Archive

April 2014 recalls

645 recalls were announced in April 2014.

What the numbers show

Critical
60
Severe
147
High
256
Moderate
162
Low
20

Of the 645 recalls this month scored against our rubric, 9% are Critical, 23% are Severe.

301–400 of 645

  • HighNHTSA·14V193000·2014-04-16

    Wheeled Coach Recalls Ambulances Due to Electrical Timer Power Loss

    Wheeled Coach is recalling specific ambulances because an electrical timer may lose power, potentially cutting electricity to the patient area and increasing injury risk.

    Product
    WHEELED COACH — WHEELED COACH T1, AMBULANCE-M2 CHASSIS, T3, T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1443-2014·2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged, potentially causing blood or IV fluid leaks.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2014·2014-04-16

    Playtex Electric Breast Pump Recall Due to Power Adapter Shock Risk

    Energizer Personal Care is recalling Playtex Deluxe Double Electric Breast Pumps because loose power adapter casings may cause electric shock.

    Product
    Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1753-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters because an anti-stick spray containing soy lecithin was used during manufacture, and soy was not declared on the label.

    Product
    i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters. UPC 736211884442 - 4 oz 12 units/cs
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2014·2014-04-16

    Medcare Floor Lifts Recalled Due to Potential Pin Failure

    ErgoSafe Product LLC is recalling Medcare Floor Lifts manufactured between 2010 and 2012 because a design pin may break over time.

    Product
    400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1444-2014·2014-04-16

    Smiths Medical HOTLINE Fluid Warming Set Recall for Injection Port Leaks

    Smiths Medical is recalling HOTLINE Fluid Warming Sets because the injection port septum may leak or become dislodged.

    Product
    Smiths Medical HOTLINE¿ Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1429-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.

    Product
    10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Drugs)·D-1209-2014·2014-04-16

    Terra-Medica Recalls Pleo Ex Suppositories Due to Penicillin Cross-Contamination

    Terra-Medica Inc. is recalling Pleo Ex Suppositories because of penicillin cross-contamination. The affected homeopathic antifungal products were distributed in the US, Canada, and the Philippines.

    Product
    Pleo Ex SUPPOSITORIES 3X, 10 Suppository Packages; Homeopathic Antifungal Medicine, OTC Only. Made in Germany. Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1001-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1428-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1752-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Cranberry Cashew Quinoa Clusters because soy lecithin was used in manufacturing but not declared on the label.

    Product
    i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits

    Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.

    Product
    15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighCPSC·14730·2014-04-16

    GunBox Recalls Gun Storage Boxes Due to Locking Mechanism Failure

    The GunBox LLC is recalling about 1,000 gun storage boxes because the locking mechanism can open if dropped, allowing access to the gun inside.

    Product
    The GunBox™ Gun Storage Boxes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2014·2014-04-16

    DePuy Shoulder Guide Pin Recall Due to Breakage Risk

    DePuy Orthopaedics is recalling 21,675 GLOBAL Anchor Peg Glenoid Plus 2.5mm Breakaway Guide Pins because they may break and be left in patients during surgery.

    Product
    GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1427-2014·2014-04-16

    Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns

    Aspen Surgical Products is recalling wound drainage kits due to a potential compromise of the sterile barrier, posing a risk of infection.

    Product
    10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighNHTSA·14V197000·2014-04-16

    Cummings recalls wheelchair lifts on Ford and Chevrolet vans

    Cummings Mobility is recalling wheelchair lifts on certain Ford and Chevrolet vans because roll stop latches may bend, posing a fall risk.

    Product
    FORD — FORD, CHEVROLET E-350, C5500, G3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V194000·2014-04-16

    Free Spirit Recreational Vehicles Recalled for Trailer Wiring Defect

    Triple E Recreational Vehicles is recalling 2012-2014 Free Spirit models because trailer hazard lights may not work when the RV ignition is off.

    Product
    FREE SPIRIT — FREE SPIRIT FS22SS, FS22, FS22TE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1749-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters because soy was not declared on the label.

    Product
    i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1759-2014·2014-04-16

    Bay State Milling Recalls Wing Bran Due to Metal Fragments

    Bay State Milling is voluntarily recalling specific lots of Wing Bran produced in February and March 2014 due to the presence of metal fragments.

    Product
    Wing Bran-Bkrs 40# 30/PAL720600, #14535 , Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72060 5, Ingredients Wheat Bran. Wingold Bran - Bakers 40#720500, Contains Wheat 40.00 lbs (18.14 kg), UPC 7 96800 72050 6, Ingredients What Bran.
    Category
    Food
    Distribution
    14 states
  • HighFDA (Food)·F-1750-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Almond All Natural Quinoa Clusters because soy lecithin was used in manufacturing but not declared on the label.

    Product
    i heart keenwah Almond All Natural Quinoa Clusters. UPC 736211802347 for the 4 oz UPC 713757598200 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1747-2014·2014-04-16

    Northern Valley Baking Recalls G'nache P'nache for Undeclared Milk and Soy

    Northern Valley Baking Co. is recalling G'nache P'nache products because milk and soy were not declared on the allergen statement.

    Product
    The Other Macaroon G'nache P'nache 5.3 oz. Manufactured and Distributed by:Northern Valley Baking Co LLC, Dumont, New Jersey USA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1205-2014·2014-04-16

    Terra-Medica Recalls Pleo Fort Capsules Due to Penicillin Cross Contamination

    Terra-Medica Inc. is recalling Pleo Fort Capsules 4X due to penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

    Product
    Pleo Fort CAPSULES 4X, 20 Capsule Cartons Homeopathic Digestive Aid Medicine, OTC Only. Made in Germany for: SANUM USA Copr, 1456 Slater Road, Ferndale, WA 98248 by Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-1103-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1434-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.

    Product
    7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1422-2014·2014-04-16

    Aspen Surgical Recalls Sterile Bulb Evacuator Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially increasing infection risk.

    Product
    Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1451-2014·2014-04-16

    Harbor Freight Recalls Sit/Stand Rolling Walkers Due to Wheel Detachment Risk

    Harbor Freight Tools is recalling Sit/Stand Rolling Walkers because wheels may detach over time, posing a hazard to users.

    Product
    Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1332-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System due to potential damage during use and to update labeling instructions.

    Product
    5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1435-2014·2014-04-16

    Aspen Surgical Recalls Sterile Drain Kits Due to Sterility Compromise

    Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.

    Product
    7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1447-2014·2014-04-16

    Breg Recalls Knee Supports for Missing Latex Warning Labels

    Breg Inc is recalling two knee support models because they contain latex but lack the required caution label.

    Product
    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1418-2014·2014-04-16

    Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise

    Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.

    Product
    10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1430-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits

    Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.

    Product
    7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1419-2014·2014-04-16

    Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns

    Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.

    Product
    10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1452-2014·2014-04-16

    Draeger Recalls Reusable Latex Breathing Bags Due to Allergic Reaction Incident

    Draeger Medical is recalling reusable latex breathing bags and test lungs after a user reported an acute allergic reaction. The product is distributed nationwide.

    Product
    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1426-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.

    Product
    19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1818-2014·2014-04-16

    Command Nutritionals Recalls Juggernaut and Hard Blast Drinks for Contaminated Ingredient

    Command Nutritionals is recalling Juggernaut and Hard Blast-Pink Lemonade products due to contaminated L-Citrulline received from a supplier.

    Product
    Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs. Manufactured in the USA Infinite Labs, LLC PO Box 533736 Orlando, FL 32853 1-877-455-2271
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-1198-2014·2014-04-16

    Terra-Medica Recalls Pleo Not Portable Sips Due to Penicillin Contamination

    Terra-Medica Inc. is recalling specific batches of Pleo Not Portable Sips oral homeopathic medicine due to penicillin cross-contamination.

    Product
    Pleo Not PORTABLE SIPS 7X,10 x 1 mL Cartons, Oral Homeopathic Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp., 1465 Slater Road, Ferndale, WA 98248. Manufactured by: Sanum-Kehlbeck GmbH & Co. KG. NDC: 49807-2310-1. Pleo Not PORTABLE SIPS 7X, 50 x 1 mL Ca
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1193-2014·2014-04-16

    Terra-Medica Recalls Pleo Not Capsules Due to Penicillin Cross Contamination

    Terra-Medica Inc. is recalling Pleo Not Capsules 4X because of penicillin cross contamination. The product was distributed in the US, Canada, and the Philippines.

    Product
    Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppressant/ Decongestant Medicine, OTC Only. Made in Germany, Distributed by: SANUM USA Corp.,1465 Slater Road, Fernadale, WA 98248; Manufactured By: SANUM-Kehlbeck GmbH & Co. KG. NDC: 49807-2303-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1446-2014·2014-04-16

    Breg Recalls Knee Sleeves for Missing Latex Warning Labels

    Breg Inc is recalling specific knee sleeves because they contain latex but lack the required caution labels.

    Product
    Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1423-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1421-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.

    Product
    Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1438-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recall for Software Communication Failure

    Philips is recalling HeartStart XL+ Defibrillators because a software failure may lock users out of clinical mode, potentially delaying therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1432-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.

    Product
    15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1335-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for da Vinci System

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use. The recall also includes labeling updates to guide inspection and handling.

    Product
    5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1439-2014·2014-04-16

    Philips HeartStart XL+ Defibrillator Recalled for Therapy Board Malfunction

    Philips is recalling 19 HeartStart XL+ defibrillators because a therapy board component could malfunction, potentially affecting the device's ability to deliver therapy.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1445-2014·2014-04-16

    Alcon LenSx Ophthalmic Laser Recalled for Gantry Motion Defect

    Alcon LenSx is recalling 75 ophthalmic lasers used in cataract surgery due to reports of unexpected downward motion of the gantry.

    Product
    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1417-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1425-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-1431-2014·2014-04-16

    Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.

    Product
    10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1760-2014·2014-04-16

    Fannie May Assorted Chocolates Recalled for Undeclared Peanut Allergen

    Fannie May Confections Brands, Inc. is recalling specific lots of Assorted Chocolates because the ingredient statement fails to declare peanuts.

    Product
    Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorted Chocolates Nutrition Facts:***Ingredients: SUGAR, MILK CHOC LATES***CONTAINS: EGGS, MILK, SOY, TREE NUTS. WHEAT, GLUTEN***Distributed By: Fan
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1433-2014·2014-04-16

    Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns

    Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.

    Product
    19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Food)·F-1751-2014·2014-04-16

    Keen-Wah Quinoa Clusters Recalled for Undeclared Soy Allergen

    Keen-Wah LLC is recalling i heart keenwah Ginger Peanut All Natural Quinoa Clusters because an anti-stick spray containing soy lecithin was used during manufacturing, but soy was not declared on the label.

    Product
    i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1333-2014·2014-04-16

    Intuitive Surgical Recalls 5mm Curved Cannulae for Potential Damage

    Intuitive Surgical is recalling 5,217 5mm Curved Cannulae for the da Vinci Si Surgical System because they may become damaged during use.

    Product
    5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1742-2014·2014-04-16

    Evolution Fresh Recalls Organic Sweet Greens and Ginger Juice

    Evolution Fresh is recalling Organic Sweet Greens and Ginger Juice out of an abundance of caution.

    Product
    Evolution fresh Organic sweet Greens and Ginger, 15.2 fluid-ounce bottle, 6 bottles/case, UPC code is 762357378927.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1400-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Propoxyphene Test Strips because they were shipped to US locations without required FDA clearance.

    Product
    Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1365-2014·2014-04-16

    LumiQuick Recalls Tramadol Test Cards for Unapproved Distribution

    LumiQuick Diagnostics is recalling Tramadol Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Tramadol Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1390-2014·2014-04-16

    LumiQuick THC Strip Recalled for Unauthorized Distribution in US

    LumiQuick Diagnostics Inc. is recalling all lots of THC Strip (Catalog 74035) because they were shipped to US locations without required FDA clearance.

    Product
    THC Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1382-2014·2014-04-16

    LumiQuick Methamphetamine Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Methamphetamine Strips because they were shipped to US locations without required FDA clearances.

    Product
    Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1416-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1355-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Syphilis Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1338-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Syphilis Test Cards because they were shipped to locations without required FDA clearances.

    Product
    Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1397-2014·2014-04-16

    LumiQuick Oxycodone Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Oxycodone Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Oxycodone Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1373-2014·2014-04-16

    LumiQuick Benzodiazepine Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling Benzodiazepine Test Cards because they were shipped to US locations without approved FDA applications.

    Product
    Benzodiazepine Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1406-2014·2014-04-16

    LumiQuick Clonazepam Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Clonazepam Test Cards because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Clonazepam Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1411-2014·2014-04-16

    LumiQuick Cardiac Panel Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.

    Product
    Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1378-2014·2014-04-16

    LumiQuick MDMA/Ecstasy Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.

    Product
    MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1816-2014·2014-04-16

    Lam Sheng Kee Recalls Diced Dry Bean Curd for Unapproved Dyes

    Lam Sheng Kee (Usa) Enterprise C is recalling Diced Dry Bean Curd distributed in New York because it contains unapproved dyes and undeclared FD&C Yellow #6.

    Product
    Diced Dry Bean Curd. Manufactured by: E Won Trading Company, LTD. Distributed by: Win Luck Trading Co. LLC, 100 Pulaski Street, Bayonne, NJ 07002. UPC 4716670715248. 10.58 oz (300g) plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1352-2014·2014-04-16

    LumiQuick Malaria Pan Antigen Test Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Malaria pan Antigen Tests because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1396-2014·2014-04-16

    LumiQuick Oxycodone Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Oxycodone Strips because they were shipped to US locations without required FDA clearance.

    Product
    Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1405-2014·2014-04-16

    LumiQuick Fentanyl Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Fentanyl Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1403-2014·2014-04-16

    LumiQuick Fentanyl Test Strips Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Fentanyl Test Strips because they were shipped to US locations without approved FDA applications.

    Product
    Fentanyl Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1395-2014·2014-04-16

    LumiQuick Buprenorphine Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Buprenorphine Test Cards because they were shipped to locations without required FDA approvals.

    Product
    Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1410-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.

    Product
    Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1412-2014·2014-04-16

    LumiQuick Cardiac Panel Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics is recalling Cardiac Panel Test Cards because they were shipped to locations without approved regulatory clearance.

    Product
    Cardiac Panel Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1748-2014·2014-04-16

    Prego Italian Sauce Recalled for Potential Spoilage from Cleaning Solution

    Campbell Soup Supply Co. is recalling Prego Italian Sauce Traditional due to potential spoilage caused by elevated pH from dilute cleaning solution.

    Product
    Prego Italian Sauce Traditional, NET WT. 24 OZ (1 LB. 80 Z.)(680 g) in glass jars.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1339-2014·2014-04-16

    LumiQuick Rickettsia Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.

    Product
    Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1389-2014·2014-04-16

    LumiQuick PCP Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.

    Product
    PCP Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1341-2014·2014-04-16

    LumiQuick H. Pylori Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling H. Pylori Antigen Test Cards because they were shipped to locations without required FDA clearance.

    Product
    H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1374-2014·2014-04-16

    LumiQuick Cocaine Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.

    Product
    Cocaine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1388-2014·2014-04-16

    LumiQuick PCP Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling PCP Test Strips distributed to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    PCP Test (Strip); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1402-2014·2014-04-16

    LumiQuick Methylphenidate Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Methylphenidate Test Cards because they were shipped to locations without required FDA regulatory clearance.

    Product
    Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1379-2014·2014-04-16

    LumiQuick MDMA Test Card Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling MDMA/Ecstasy Test Cards because they were shipped to locations without required FDA clearance.

    Product
    MDMA/Ecstasy Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1376-2014·2014-04-16

    LumiQuick EDDP Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling EDDP Strips because they were shipped to US locations without required FDA clearance.

    Product
    EDDP Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1756-2014·2014-04-16

    Smiley National Recalls Kratom Products Due to Unapproved Dietary Ingredients

    Smiley National is voluntarily recalling specific Kratom products because they contain unapproved dietary ingredients.

    Product
    Enhanced Maeng Da Leaf Powder, Maeng Da Kratom, capsule, UPC code 5410600330, 10 Pack, 2 Servings Per Pack, 10 grams.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1345-2014·2014-04-16

    LumiQuick Adenovirus Antigen Test Card Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling all lots of the Adenovirus Antigen Test Card because they were shipped to locations without approved FDA applications.

    Product
    Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1353-2014·2014-04-16

    LumiQuick Salmonella Antigen Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Salmonella typhi/paratyphi Antigen Tests because they were shipped to locations without FDA approval.

    Product
    Salmonella typhi/paratyphi Antigen Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1414-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Myoglobin Test Cards because they were shipped to locations without FDA clearance.

    Product
    Myoglobin Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1377-2014·2014-04-16

    LumiQuick EDDP Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling EDDP Test Cards because they were shipped to locations without required FDA approvals.

    Product
    EDDP Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1361-2014·2014-04-16

    LumiQuick PSA Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling PSA Test Cards shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1344-2014·2014-04-16

    LumiQuick Rotavirus Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling all lots of its Rotavirus Test Card because they were shipped to US locations without approved FDA clearance.

    Product
    Rotavirus Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1436-2014·2014-04-16

    Clinical Diagnostic Solutions Recalls Hematology Control Material Due to Elevated MCV

    Clinical Diagnostic Solutions is recalling Boule Con-Diff Tri-Level Hematology Control material because of elevated MCV results in specific lots.

    Product
    Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2014·2014-04-16

    LumiQuick Morphine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Morphine Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1407-2014·2014-04-16

    LumiQuick K2 Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling K2 Test Strips because they were shipped to locations without FDA clearance.

    Product
    K2 (synthetic Marijuana) Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1372-2014·2014-04-16

    LumiQuick Benzodiazepine Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Benzodiazepine Strips because they were shipped to US locations without required FDA clearances.

    Product
    Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1449-2014·2014-04-16

    Roche Cobas c502 Analyzer Recall Due to Inactive Volume Check

    Roche Diagnostics is recalling 76 Cobas c502 clinical chemistry analyzers because the Initial Cassette Volume Check feature fails to activate when specific reagent packs are loaded.

    Product
    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2014·2014-04-16

    LumiQuick Saliva Alcohol Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling all lots of its Saliva Alcohol Test (Catalog 74001) because the products were shipped to US locations without approved regulatory clearance.

    Product
    Alcohol Test, Saliva; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-1761-2014·2014-04-16

    Vitacost L-Citrulline Amino Acid Supplement Recalled for Contamination

    Nature's Value Inc. is recalling Vitacost brand L-Citrulline Amino Acid 750 mg capsules because the bulk ingredient contained an unidentified compound.

    Product
    vitacost brand L-Citrulline Amino Acid 750 mg, 90 CAPSULES, DIETARY SUPPLEMENT, ITEM # NSI 3003310, UPC 8 35003 00331 0 --- Manufactured for Vitacost Lexington, NC 27295
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1225-2014·2014-04-16

    Agila Recalls Etomidate Injection Due to Particulate Matter and Labeling Issues

    Agila Specialties Private Ltd. is recalling etomidate injection vials due to potential particulate matter and missing or illegible lot and expiry date labels.

    Product
    etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC 0069-0006-
    Category
    Drug
    Distribution
    Distributed nationwide

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