The Recall Desk

Archive

July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical
104
Severe
251
High
252
Moderate
109
Low
25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 34% are Severe.

Which agencies issued them

101–200 of 741

  • LowFDA (Drugs)·D-816-2013·2013-07-31

    LA MER Sunscreen Recalled for Potentially Subpotent Active Ingredient

    Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient Avobenzone may be subpotent, reducing sunscreen effectiveness.

    Product
    LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1779-2013·2013-07-31

    National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual

    National Biological Corp is recalling six Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-080 device.

    Product
    Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-823-2013·2013-07-31

    Watson Recalls Oxycodone and Acetaminophen Capsules Due to Low Potency

    Watson Laboratories is recalling two lots of Oxycodone and Acetaminophen Capsules because the oxycodone content was found to be below specification at expiry.

    Product
    Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·13E041000·2013-07-30

    Cequent Recalls Tekonsha Electric Trailer Brake Control Wiring Adapters

    Cequent is recalling Tekonsha Electric Trailer Brake Control Wiring Adapters used on 2013 Dodge Ram 1500 vehicles because the turn signal may malfunction, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V328000·2013-07-29

    Kawasaki Recalls 2013 Ninja 300 Motorcycles for ECU Stall Risk

    Kawasaki is recalling 2013 Ninja 300 motorcycles because an ECU error may cause the bike to stall during deceleration, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI NINJA 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13249·2013-07-25

    Home Depot Recalls Soleil Portable Fan Heaters Due to Fire Hazard

    Home Depot is recalling Soleil portable fan heaters because the plastic housing can melt and catch fire. Consumers should stop using the units and return them for a refund.

    Product
    Soleil portable fan heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13744·2013-07-25

    Lennox and Superior gas fireplaces recalled due to gas leak risk

    Lennox Hearth Products is recalling about 11,500 gas fireplaces because defective connectors can leak gas, posing a fire hazard. No injuries have been reported.

    Product
    Lennox and Superior gas fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1723-2013·2013-07-24

    MR Cuts Recalls Mango Chunks Due to Salmonella Contamination Risk

    MR Cuts, L.p. is recalling Item # 2999 Mango Chunks because the product has the potential to be contaminated with salmonella.

    Product
    Item # 2999 Mango Chunks 2/5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1711-2013·2013-07-24

    Fresh Unlimited Broccoli Salad Kit Recalled for Listeria Contamination

    Fresh Unlimited Inc is recalling Broccoli Salad Kit No Dressing because a supplier ingredient was linked to a Listeria monocytogenes recall.

    Product
    Broccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-1690-2013·2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1691-2013·2013-07-24

    Codman MedStream Infusion Pump Recalled for Miscalibrated Fill Level Sensor

    Codman & Shurtleff is recalling MedStream Programmable Infusion Pumps because a miscalibrated fill level sensor may affect dosing levels.

    Product
    MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1712-2013·2013-07-24

    Fresh Unlimited Broccoli Salad Kit Recalled for Listeria Contamination

    Fresh Unlimited Inc is recalling Broccoli Salad Kit No Dressing, No Bacon because a supplier's sunflower raisin mix was contaminated with Listeria monocytogenes.

    Product
    Broccoli Salad Kit No Dressing, No Bacon; packaged in plastic bags inside paper cartons, 4 bags per case.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1720-2013·2013-07-24

    Windy Acres Recalls Sunflower Kernel and Raisin Mix for Listeria Risk

    Windy Acres Candy & Nut is recalling a raw sunflower kernel and dark raisin mix because the supplier reported potential Listeria monocytogenes contamination.

    Product
    RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1713-2013·2013-07-24

    Fresh Unlimited Broccoli Salad Kit Recalled for Listeria Contamination

    Fresh Unlimited Inc is recalling Broccoli Salad Kits because a supplier's sunflower raisin mix packets were contaminated with Listeria monocytogenes.

    Product
    Broccoli Salad Kit with Dressing; packaged in plastic bags inside paper cartons, 5 bags per case.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1714-2013·2013-07-24

    Fresh Unlimited Recalls Sweet & Sassy Apple Salad Due to Listeria

    Fresh Unlimited Inc is recalling Sweet & Sassy Apple Salad because a supplier ingredient was linked to a Listeria monocytogenes contamination.

    Product
    Sweet & Sassy Apple Salad; packaged in plastic bags inside paper cartons, 5 bags per case.
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·13V323000·2013-07-24

    Moto Guzzi Recalls 2012-2013 Models for Rear Suspension Defect

    Piaggio is recalling 680 Moto Guzzi motorcycles because rear suspension links could fracture, increasing the risk of a crash.

    Product
    MOTO GUZZI — MOTO GUZZI NORGE 1200, STELVIO NTX 1200, GRISO 1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-806-2013·2013-07-24

    Apotex Recalls Piperacillin and Tazobactam Injection Due to Crystallization Risk

    Apotex Corp. is recalling 37,303 vials of Piperacillin and Tazobactam for Injection due to a risk of precipitation or crystallization in IV bags or lines.

    Product
    Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-804-2013·2013-07-24

    Fresenius Kabi Recalls Subpotent Oxytocin Injection Vials

    Fresenius Kabi is recalling 221,600 vials of Oxytocin Injection, USP, due to a subpotent drug issue identified during a 15-month stability test.

    Product
    Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-805-2013·2013-07-24

    Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error

    Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.

    Product
    Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·13V324000·2013-07-24

    Nissan Recalls 2014 Versa Note Vehicles for Body Sill Bolt Defect

    Nissan is recalling 2014 Versa Note vehicles because lower body sill bolts may be missing or incorrectly torqued, which could affect vehicle integrity in a rear impact.

    Product
    NISSAN — NISSAN VERSA NOTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1753-2013·2013-07-24

    Liebel-Flarsheim Hydra Vision DR 60/80 System Recalled for High Dosage

    Liebel-Flarsheim is recalling 12 Hydra Vision DR 60/80 systems because a service call found the maximum fluoroscopy dose was three times the safety limit.

    Product
    Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1739-2013·2013-07-24

    St. Jude Medical Recalls Eon Mini Spinal Cord Stimulator Chargers

    St. Jude Medical is recalling Eon Mini chargers due to reports of skin burns and discomfort at the implant site during charging.

    Product
    Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V327000·2013-07-24

    Setra Recalls 2013 S417TC Buses Due to Rear Axle Bolt Issue

    Setra is recalling 2013 S417TC buses because a rear axle bolted joint could loosen, potentially reducing steering control and increasing crash risk.

    Product
    SETRA — SETRA S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1738-2013·2013-07-24

    St. Jude Medical Recalls Eon Spinal Cord Stimulator Charging Systems

    St. Jude Medical is recalling Eon and Eon Mini charging systems due to reports of skin burns and discomfort at the implant site during use.

    Product
    Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-799-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 3 Fine Powdered, Net Wt. 50 lbs. (22.68 kg.) per
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-801-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Foreign Substance Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 5 Coarse Granular, Net Wt. 50 lbs. (22.68 kg.) pe
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1721-2013·2013-07-24

    MR Cuts Recalls Diced Mango Products Due to Salmonella Risk

    MR Cuts, L.p. is recalling diced mango products sourced from Agricola Daniella due to potential Salmonella contamination. The products were distributed in Texas.

    Product
    Item # H996189 Mango Diced 1/2" 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1722-2013·2013-07-24

    MR Cuts Recalls Sliced Mango Products Due to Salmonella Risk

    MR Cuts, L.p. is recalling sliced mango products sourced from Agricola Daniella due to potential Salmonella contamination. The products were distributed in Texas.

    Product
    Item # H175455 Mango Sliced 2/2.5 LB and 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico
    Category
    Food
    Distribution
    1 state
  • HighCPSC·13743·2013-07-24

    Big Lots Recalls Holiday Pathway Light Sets Due to Fire Hazard

    Big Lots is recalling about 29,500 Holiday Light Bulb Sets because the non-flame-retardant components pose a fire hazard. Consumers should stop using the lights and return them for a refund.

    Product
    Holiday Light Bulb Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1742-2013·2013-07-24

    Stryker RemB Electric Universal Driver Recalled for Unintended Activation

    Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.

    Product
    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Un
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2013·2013-07-24

    KooJoo Trading Company Recalls Unsterilized Safety Lancets

    KooJoo Trading Company is recalling specific lots of Odyssey safety lancets because they were not sterilized within the established validation dose range.

    Product
    Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1751-2013·2013-07-24

    Hospira Recalls Symbiq IV Pump Sets Due to Air-in-Line Alarm Risk

    Hospira is recalling Symbiq IV pump sets because a defective ball valve may fail to seal, causing air-in-line alarms during fluid administration.

    Product
    LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1717-2013·2013-07-24

    Talenti Gelato Toasted Almond Recalled for Undeclared Pecans

    Talenti Gelato is recalling Toasted Almond flavor due to undeclared pecans. Consumers should check their freezers for the specific lot number.

    Product
    Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-1727-2013·2013-07-24

    Roche B-CrossLaps/serum Immunoassay Recalled for Unreliable Biotin Interference Claims

    Roche Diagnostics is recalling B-CrossLaps/serum immunoassays because internal investigations showed the package insert's claims regarding biotin interference and sample stability could not be reproduced.

    Product
    B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2013·2013-07-24

    Stryker CORE Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.

    Product
    CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2013·2013-07-24

    Stryker TPS Universal Driver Recalled for Unintended Activation Risk

    Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.

    Product
    Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, max
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Inaccuracies

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because software inaccuracies may affect monitoring during cardiopulmonary bypass.

    Product
    CDI Blood Parameter Monitoring System 500 with Venous blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2013·2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling nanoFLEX and Afinity intraocular lenses because glass particles may be present in the storage vials.

    Product
    nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling 3,972 CDI 500 Blood Parameter Monitoring Systems because a software algorithm inaccuracy was discovered during internal testing.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1724-2013·2013-07-24

    Sani Fresh Mini Kaiser Rolls Recalled for Undeclared Soy and Wheat

    Sani Fresh Distribution is recalling Mini Kaiser 10 rolls due to undeclared soy, wheat, sulfites, and gluten. The product was distributed in Queens, NY.

    Product
    Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1718-2013·2013-07-24

    Kroger Recalls QFC Chicken Pesto Panini for Allergen Mislabeling

    Kroger is recalling QFC Chicken Pesto Paninis in Washington and Oregon because they may contain undeclared soy and egg allergens.

    Product
    QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count "variety pack" case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1716-2013·2013-07-24

    Kenton's Cheese Company Recalls Bianco Brie-Style Cheese Due to E. coli

    Kenton's Cheese Company is recalling Bianco Brie-Style Cheese due to E. coli contamination. Consumers should return the product for a full refund.

    Product
    KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1719-2013·2013-07-24

    Nassau Candy Recalls Pistachios for Potential Salmonella Contamination

    Nassau Candy is recalling 6.25 lb packages of in-shell pistachios due to potential Salmonella contamination. The product was distributed across 13 states.

    Product
    PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801.
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1747-2013·2013-07-24

    Staar Surgical Recalls Intraocular Lenses Due to Glass Particles

    Staar Surgical is recalling specific Afinity and nanoFLEX intraocular lenses because glass particles may be present in the storage vials.

    Product
    Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System Due to Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System because software inaccuracies were found in the algorithm. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2013·2013-07-24

    SpineFrontier Recalls KRD1 PedFuse Rods Due to Fatigue Testing Failures

    SpineFrontier, Inc. is recalling KRD1 PedFuse Rods because one rod in each of two test constructs failed to meet fatigue requirements during dynamic compression testing.

    Product
    KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be place
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-798-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Foreign Substance Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 2 Fine Granular, Net Wt. 50 lbs. (22.68 kg.) per
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2013·2013-07-24

    Edwards Lifesciences Recalls Suction Wands Due to Plastic Particulate

    Edwards Lifesciences is recalling specific models of rigid suction wands because plastic particulate was found inside the sterile pouch and within the wand.

    Product
    Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2013·2013-07-24

    Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment

    Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.

    Product
    Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1750-2013·2013-07-24

    Siemens AXIOM Artis zee/zeego Systems Recalled for Generator Power Supply Defect

    Siemens is recalling 23 AXIOM Artis zee/zeego angiographic x-ray systems because a tolerance problem in the generator power supply may cause the generator to fail.

    Product
    Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1730-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring System for Software Error

    Terumo is recalling the CDI 500 Blood Parameter Monitoring System due to software algorithm inaccuracies. A software update is being developed to correct the issue.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hema
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1744-2013·2013-07-24

    Zeiss Microscope Polarizer D Component Recalled for Misaligned Plate

    Carl Zeiss Microscopy is recalling Polarizer D components for upright Zeiss microscopes due to a misaligned full-wave plate.

    Product
    Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1726-2013·2013-07-24

    Synthes CMF Distraction System Recalled for Misalignment

    Synthes USA HQ, Inc. is voluntarily recalling 10 units of the Synthes CMF Distraction System due to a misalignment issue that prevents the attachment of specific foot plates.

    Product
    Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2013·2013-07-24

    Terumo Recalls CDI 500 Blood Parameter Monitoring Systems

    Terumo is recalling CDI 500 Blood Parameter Monitoring Systems because software contains unused accuracy correction factors for hematocrit and saturation calculations.

    Product
    CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperatur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-802-2013·2013-07-24

    Quetiapine Fumarate Tablets Recalled for Failed Dissolution Test

    American Health Packaging is recalling Quetiapine Fumarate 25mg tablets because they failed a dissolution test during stability studies.

    Product
    QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2013·2013-07-24

    Paa Laboratories Recalls Fetal Bovine Serum Due to Mislabeling

    Paa Laboratories is recalling approximately 280,000 liters of Fetal Bovine Serum because some products labeled as pure may contain added adult Bovine Serum Albumin.

    Product
    Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1715-2013·2013-07-24

    Somersault Pacific Sea Salt Snacks Recalled for Flavor Mislabeling

    Somersault Snack Co. is recalling Pacific Sea Salt flavored nuggets because they were mispackaged with Santa Fe Salsa flavor. Consumers should check their packages for specific UPCs and sell-by dates.

    Product
    Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1745-2013·2013-07-24

    Synthes Recalls Multi Vector Distractor Pin Holding Clamps Due to Binding

    Synthes USA is voluntarily removing Multi Vector Distractor Pin Holding Clamps because the clamp and nut construct may fail to engage threads and bind.

    Product
    Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-800-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., Princeton, N.J. 08543-5297, Product #60411.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1752-2013·2013-07-24

    Baxter Recalls ExactaMix Compounders Due to Battery Clock Reset

    Baxter Healthcare is recalling ExactaMix 1200 and 2400 compounders because a battery failure causes the internal clock to reset to midnight on December 31, 2010.

    Product
    ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2013·2013-07-24

    Karl Storz Balloon Catheter Recalled for Potential Sterility Compromise

    Karl Storz Endoscopy America is recalling 27023WU Balloon Catheters because packaging defects may compromise sterility. The recall affects 40 units distributed to five US states.

    Product
    27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-797-2013·2013-07-24

    Arm & Hammer Sodium Bicarbonate Powder Recalled for Contamination

    Church & Dwight is recalling Arm & Hammer Sodium Bicarbonate Powder due to the presence of stainless steel and other foreign substances.

    Product
    Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1743-2013·2013-07-24

    Technidata TDHistology Software Recall for Electronic Transmission Symbol Errors

    Technidata is recalling TDHistology/Cytology software because unsupported symbols in Microsoft Word reports may cause errors during electronic transmission of results.

    Product
    TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1748-2013·2013-07-24

    Boston Scientific Recalls Alair Bronchial Thermoplasty Catheters Due to Labeling Error

    Boston Scientific is recalling 35 units of Alair Bronchial Thermoplasty Catheters because the expiration date on the inner tray is incorrect.

    Product
    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-807-2013·2013-07-24

    Bayer Recalls Medroxyprogesterone Acetate API Due to Stability Failures

    Bayer HealthCare Pharmaceuticals Inc. is recalling 194.62 kg of Medroxyprogesterone acetate API because it failed stability specifications for particle size.

    Product
    Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin
    Category
    Drug
    Distribution
    2 states
  • SevereCPSC·13244·2013-07-23

    Kids II Recalls Baby Einstein Activity Jumpers Due to Impact Hazard

    Kids II is recalling Baby Einstein Musical Motion Activity Jumpers because the sun toy attachment can snap backward and injure infants.

    Product
    Baby Einstein Musical Motion Activity Jumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V322000·2013-07-23

    Kenworth Recalls 2010-2012 T4 and W9 Series Vehicles for Fire Risk

    PACCAR is recalling 802 Kenworth T4 and W9 series vehicles because alternator wiring may contact the exhaust manifold, potentially causing a vehicle fire.

    Product
    KENWORTH — KENWORTH T4 SERIES, W9 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V320000·2013-07-23

    Navistar Recalls IC School Buses for Flip Seat Pinch Hazard

    Navistar is recalling certain IC school buses equipped with C. E. White Inc. flip seats due to a risk of foot or toe pinch injuries.

    Product
    IC BUS — IC BUS, IC RESB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13246·2013-07-23

    Girls' Boots Recalled by Renaissance Imports Due to Laceration Hazard

    Renaissance Imports is recalling Autumn Run Girls Gemma II Boots sold at Academy Sports + Outdoors because an exposed staple in the sole presents a laceration hazard.

    Product
    Autumn Run Girls Gemma II Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V321000·2013-07-23

    Compass Conversions Recalls 2003 Elite and 2007 Bloomer Horse Trailers

    Compass Conversions is recalling specific 2003 Elite and 2007 Bloomer horse trailers because power awning motor screws may shear, causing the awning to unfurl unexpectedly.

    Product
    BLOOMER — BLOOMER, ELITE HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V317000·2013-07-22

    Temsa Recalls 2013 TS30 Buses Due to Axle Shaft Breakage Risk

    Temsa is recalling 10 model year 2013 TS30 buses because improper heat treatment may cause axle shafts to break, increasing crash risk.

    Product
    TEMSA — TEMSA TS30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V319000·2013-07-22

    Triumph Recalls 2012-2013 Motorcycles Due to ABS Malfunction Risk

    Triumph is recalling 1,887 model year 2012-2013 Street Triple and Daytona 675 motorcycles because the Anti-Lock Brake System may malfunction, increasing crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E040000·2013-07-22

    Honda Recalls Trailer Hitch Harness Kits for 2014 Acura MDX

    Honda is recalling trailer hitch harness kits for 2014 Acura MDX vehicles because incorrect wiring may prevent power to the trailer brake controller, increasing crash risk.

    Product
    ACURA — ACURA MDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V318000·2013-07-22

    Winnebago Recalls 2011 Motorhomes Due to Incorrect Tire Labeling

    Winnebago is recalling 2011 Vista and Itasca Sunstar motorhomes because the Vehicle Certification Label lists incorrect tire inflation pressures and wheel rim sizes.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VISTA, SUNSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V315000·2013-07-19

    GM Recalls 2014 Silverado and Sierra Trucks for Airbag Defect

    General Motors is recalling 2014 Chevrolet Silverado and GMC Sierra trucks because a welding defect may prevent the passenger airbag from fully inflating.

    Product
    GMC — GMC, CHEVROLET SIERRA, SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1706-2013·2013-07-17

    Lipari Foods Recalls Cherry Berry Tub Mix Due to Listeria Contamination

    Lipari Foods is recalling specific tubs of Cherry Berry Mix due to potential Listeria monocytogenes contamination. Consumers in nine states should check their pantries for the affected product.

    Product
    Item Number: 423622 Item Description: TUB MD MIX CHERRY BERRY Case Pack: 12 Package Size: 12 OZ 2-Piece Clear Plastic Tub ('Cherry' Label on Top, Nutritional Label on Bottom) UPC Number: 094776111404
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1708-2013·2013-07-17

    Lipari Foods Recalls Natural Almonds Dark Chocolate Tub for Listeria Risk

    Lipari Foods is recalling 207 cases of Natural Almonds Dark Chocolate due to potential Listeria monocytogenes contamination. The product was distributed across nine states.

    Product
    Item Number: 545603 Item Description: NATURAL ALMONDS DARK CHOC Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082971
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1700-2013·2013-07-17

    Lipari Foods Recalls Raw Almonds for Listeria Contamination

    Lipari Foods is recalling 15 oz tubs of raw almonds contaminated with Listeria monocytogenes. The product was distributed across nine states.

    Product
    Item Number: 374103 Item Description: TUB LG ALMOND WHOLE RAW Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081820
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1695-2013·2013-07-17

    Lipari Foods Recalls Diet Delight Tub Due to Listeria Contamination

    Lipari Foods, Inc. is recalling 203 cases of 14-ounce Diet Delight tubs distributed across nine states due to potential contamination with Listeria monocytogenes.

    Product
    Item Number: 366568 Item Description: TUB LG MIX DIET DELIGHT Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081769
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1684-2013·2013-07-17

    Lipari Foods Recalls Jumbo Cashews for Listeria Contamination

    Lipari Foods is recalling 147 cases of 10-ounce jumbo cashews due to Listeria monocytogenes contamination. The product was distributed to nine states.

    Product
    Item Number: 204145 Item Description: TUB PAN MD CASHEW JUMBO N/S Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005061
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1613-2013·2013-07-17

    Del Monte Tropical Blend Fresh-Cut Mangoes Recalled for Salmonella Risk

    Del Monte is voluntarily recalling Tropical Blend fresh-cut mangoes due to a potential Salmonella risk associated with mangoes from a specific Mexican supplier.

    Product
    Del Monte brand Tropical Blend, 7 oz., Lot number 05262101; 16 oz., UPC 7-17524-77868-7
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1694-2013·2013-07-17

    Lipari Foods Recalls Cherry Berry Delight Mix Due to Listeria Risk

    Lipari Foods is recalling 63 cases of Cherry Berry Delight mix due to potential Listeria monocytogenes contamination. The product was distributed across nine states.

    Product
    Item Number: 365172 Item Description: BAGS MIX CHERRY BERRY DELIGHT PP Case Pack: 12 Package Size: 9.5 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110209
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1666-2013·2013-07-17

    Lipari Foods Recalls Jumbo Cashew Bags Due to Listeria Contamination

    Lipari Foods, Inc. is recalling 94 cases of 1-ounce jumbo cashew bags contaminated with Listeria monocytogenes. The product was distributed across nine states.

    Product
    Item Number: 193010 Item Description: BAGS SM CASHEW JUMBO R/S Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207022068
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1682-2013·2013-07-17

    Lipari Foods Recalls Shelled Pistachios Due to Listeria Contamination

    Lipari Foods, Inc. is recalling 144 cases of shelled pistachios due to potential contamination with Listeria monocytogenes. The product was distributed across nine states.

    Product
    Item Number: 201612 Item Description: BAGS SM PISTACHIO SHELLED R/S Case Pack: 12 Package Size: 0.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207020217
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1635-2013·2013-07-17

    ARO Pistachios Recalls Raw Inshell Pistachios Due to Salmonella Risk

    ARO Pistachios, Inc. is recalling raw inshell pistachios from the 2012 crop year because epidemiological evidence links the product to a Salmonella Senftenberg outbreak.

    Product
    ARO Pistachios, Inc., Pistachios inshell - raw; 25 lb bulk .
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-1678-2013·2013-07-17

    Lipari Foods Recalls Raw Almonds Due to Listeria monocytogenes Contamination

    Lipari Foods, Inc. is recalling 114 cases of 1.75 oz bags of raw whole almonds due to potential Listeria monocytogenes contamination.

    Product
    Item Number: 193894 Item Description: BAGS SM ALMONDS WHOLE RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018405
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1612-2013·2013-07-17

    Del Monte Tropical Fruit Bowl Recalled Due to Salmonella Risk

    Del Monte is recalling Tropical Fruit Bowls due to a potential Salmonella risk from mangoes sourced from Mexico.

    Product
    Del Monte brand Tropical Fruit Bowl, 28 oz., UPC 7-17524-77651-8; 64 oz., UPC 7-17524-77834-5
    Category
    Food
    Distribution
    6 states

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