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.

701–741 of 741

  • HighFDA (Food)·F-1562-2013·2013-07-03

    Kroger Sandwich Enriched Buns Recalled Due to Metal Fragment Risk

    BIMBO Bakeries USA is recalling Kroger Sandwich Enriched Buns due to possible metal fragments caused by a faulty manufacturing part.

    Product
    Kroger Sandwich Enriched Buns - 12 count Distributed By: The Kroger Co., Cincinnati, Ohio 45202
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1574-2013·2013-07-03

    Taylor Farms Recalls Black Forest Ham and Cheese Pretzel Rolls

    Taylor Farms is recalling Black Forest Ham and Cheese Pretzel Rolls due to potential undeclared tree nut allergens.

    Product
    Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard. Net Wt. 8.7 oz (247g). Distributed by Wawa, Inc., Wawa, PA 19063.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1556-2013·2013-07-03

    BIMBO Bakeries Recalls Colonial Party Pack Enriched Buns for Metal Fragments

    BIMBO Bakeries USA is recalling 1,689 units of Colonial Party Pack Enriched Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Colonial Party Pack Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1576-2013·2013-07-03

    See's Candies Recalls Dark and Milk Chocolate Covered Raisins for Allergen Risk

    See's Candies is recalling 4,700 pounds of dark and milk chocolate covered raisins due to potential nut and egg residue.

    Product
    See's Dark Raisins: Ingredients: Raisins, Sugar,chocolate, cocoa butter, butter (milk), vanilla, soy lecithin, Dextrin, Confectionery glaze. May contain traces of eggs, tree nuts and peanuts. Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1565-2013·2013-07-03

    Sara Lee Sesame Seed Hamburger Buns Recalled for Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee sesame seed hamburger buns due to the possible presence of metal fragments caused by a faulty manufacturing part.

    Product
    8 Bakery Buns Sara Lee Hearty & Delicious Sesame Seed and Sara Lee Gourmet Sesame Seed Hamburger Buns Restaurant Style - 12 count Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1557-2013·2013-07-03

    BIMBO Bakeries Recalls Sara Lee Sesame Seed Buns Due to Metal Fragments

    BIMBO Bakeries USA is recalling Sara Lee Colonial Party Pack Sesame Seed Enriched Buns due to possible metal fragments from a faulty manufacturing part.

    Product
    Colonial Party Pack Sesame Seed Enriched Buns - 12 count Sara Lee, Downers Grove, IL 60515
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1564-2013·2013-07-03

    Medtronic Launcher Guiding Catheter Recalled for Labeling Errors

    Medtronic is recalling 24 units of Launcher Guiding Catheters because the packaging labels do not accurately reflect the catheters inside.

    Product
    Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1587-2013·2013-07-03

    U-systems Recalls Soma v Automated Breast Ultrasound System for Labeling Error

    U-systems Inc is recalling three Soma v Automated Breast Ultrasound Systems because the user manuals incorrectly list the indication for use of a different product model.

    Product
    Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1551-2013·2013-07-03

    Enzyme Solutions Formula 29 Recalled for Labeling Error

    Enzyme Formulations, Inc. is recalling 256 bottles of Enzyme Solutions Formula 29 due to a manufacturing labeling error that resulted in incorrect contents.

    Product
    Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719.
    Category
    Food
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-621-2013·2013-07-03

    FDA Recalls Ink-Eeze Tattoo Numbing Spray for Lack of Approval

    Indelicare LLC is recalling Ink-Eeze Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-622-2013·2013-07-03

    INK-EEZE Tattoo Numbing Spray Recalled for Lack of FDA Approval

    Indelicare LLC is recalling INK-EEZE Tattoo Numbing Spray because it is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-620-2013·2013-07-03

    Kareway Recalls Pure-Aid Allergy Relief Caplets Due to Labeling Error

    Kareway Products Inc. is recalling Pure-Aid Allergy Relief caplets because the foil label incorrectly lists Chlorpheniramine instead of Diphenhydramine.

    Product
    Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-623-2013·2013-07-03

    Baxter Recalls 0.9% Sodium Chloride Injection Due to Barcode Labeling Error

    Baxter Healthcare is recalling 317,280 bags of 0.9% Sodium Chloride Injection because the barcode may incorrectly identify the product as 100 mL instead of 50 mL.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1613-2013·2013-07-03

    Beckman Coulter Recalls Lactate Reagent Due to Calibration Failures

    Beckman Coulter is recalling 3,353 units of SYNCHRON Lactate Reagent because improper storage caused calibration failures, potentially delaying test results.

    Product
    SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentratio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1550-2013·2013-07-03

    Norpac IQF Chopped Spinach Recalled for Elevated Cadmium Levels

    Norpac Foods is recalling IQF Chopped Spinach due to elevated cadmium levels. The product was distributed in California, Missouri, Oregon, and Wisconsin.

    Product
    FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: "***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen u
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1563-2013·2013-07-03

    Thermo Scientific MAS Bilirubin Recalled for Reduced Stability

    Microgenics Corporation is recalling Thermo Scientific MAS Bilirubin test samples because in-house testing confirmed reduced stability of Direct and Total Bilirubin.

    Product
    Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1585-2013·2013-07-03

    GE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss

    GE Healthcare is recalling 9 units of Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because a specific configuration can cause loss of free-text data in microbiology results.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1610-2013·2013-07-03

    Baxter Recalls Infusor Devices Due to Potential Leaks at Luer Connections

    Baxter Healthcare is recalling specific Infusor devices because of increased complaints about leaks at the distal male Luer and Luer cap.

    Product
    Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2013·2013-07-03

    Terumo Pinnacle Destination Peripheral Guiding Sheath Recalled for Labeling Error

    Terumo Medical Corporation is recalling 20 units of Pinnacle Destination Peripheral Guiding Sheaths because they were incorrectly labeled with extended expiration dates.

    Product
    Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2013·2013-07-03

    Terumo Glidesheath Recalled for Incorrect Expiration Date Labeling

    Terumo Medical Corporation is recalling 550 units of Glidesheath products due to incorrect expiration date labeling.

    Product
    Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1599-2013·2013-07-03

    ConBio Recalls Multilite Dye Handpieces for Display Identification Inconsistency

    ConBio is recalling 12 Multilite Dye Handpieces for the RevLite SI Laser due to an electronic display inconsistency that may confuse users.

    Product
    Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2013·2013-07-03

    GE Healthcare Recalls CARESCAPE Monitor B850 for Software and Hardware Issues

    GE Healthcare is recalling 12,779 CARESCAPE Monitor B850 units due to four potential issues, including uDOM failure, unstable USB communication, remote printing errors, and reboots caused by an X server freeze.

    Product
    CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2013·2013-07-03

    GE Healthcare Recalls Senographe Essential Mammography Systems Due to Manual Defect

    GE Healthcare is recalling 49 Senographe Essential mammography systems because a defective CD makes the operator manual inaccessible.

    Product
    GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1614-2013·2013-07-03

    Ortho-Clinical VITROS Potassium Slides Recalled for Unintentional Surfactant Addition

    Ortho-Clinical Diagnostics is recalling VITROS Potassium Slides because a surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1568-2013·2013-07-03

    Integra LifeSciences Recalls Ascension CMC Saddle Due to Labeling Discrepancies

    Integra LifeSciences is recalling 467 Ascension CMC Saddle implants because the US Instruction for Use contains content discrepancies compared to the FDA-cleared version.

    Product
    CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1615-2013·2013-07-03

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Manufacturing Error

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because an excess amount of surfactant was unintentionally added during manufacturing.

    Product
    VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-610-2013·2013-07-03

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling 8,808 bottles of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1596-2013·2013-07-03

    STERIS Recalls Quick Connects for Labeling Updates

    STERIS Corporation is recalling four Quick Connect products to update labeling and remove obsolete device models.

    Product
    Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, teth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V291000·2013-07-02

    Chrysler Recalls 2013 Minivans Due to Air Bag Software Defect

    Chrysler is recalling 2013 Town & Country and Dodge Grand Caravan minivans because incorrect software in the occupant restraint control module may affect air bag deployment.

    Product
    DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V282000·2013-07-02

    Chrysler Recalls 2011-2013 Vehicles for Active Head Restraint Defect

    Chrysler is recalling specific 2011-2013 models because electrical issues may prevent active head restraints from deploying in rear-end collisions, increasing injury risk.

    Product
    DODGE — DODGE, JEEP, CHRYSLER AVENGER, LIBERTY, 200, SEBRING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V288000·2013-07-02

    Chrysler Recalls 2013 RAM Trucks Due to Track Bar Bolt Defect

    Chrysler is recalling 2013 RAM 4500 and 5500 trucks because an incorrect bolt may break, causing the vehicle to pull to one side and increasing crash risk.

    Product
    RAM — RAM 5500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V286000·2013-07-02

    Kibbi Recalls 2013 Renegade Trailer Due to Awning Motor Defect

    Kibbi is recalling one 2013 Renegade KIT28TA trailer because a design change may cause awning motor screws to shear, potentially allowing the awning to unfurl unexpectedly and increasing injury or crash risk.

    Product
    RENEGADE — RENEGADE KIT28TA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13741·2013-07-02

    Yamaha Recalls Big Bear 400 ATVs Due to Front Shock Failure

    Yamaha is recalling about 100 Big Bear 400 ATVs because the front shock absorber can break, causing a crash hazard. No injuries have been reported.

    Product
    Yamaha All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V283000·2013-07-02

    Chrysler Recalls 2013 Minivans and Vans Due to Airbag Software Error

    Chrysler is recalling 2013 Town & Country, Grand Caravan, and C/V Tradesman vehicles because a software error may cause the wrong side airbags to deploy in a crash.

    Product
    CHRYSLER — CHRYSLER, DODGE, RAM TOWN AND COUNTRY, GRAND CARAVAN, C/V TRADESMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V290000·2013-07-02

    Farber Recalls 2012 Ford 550 Command Center Vehicles for Awning Motor Defect

    Farber Specialty Vehicles is recalling 2012 Ford 550 Command Center vehicles because power awning motor screws may shear, causing the awning to unfurl unexpectedly and increasing crash risk.

    Product
    FARBER SPECIALTY — FARBER SPECIALTY FORD 550 COMMAND CENTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V284000·2013-07-01

    Monaco RV Recalls 2,250 Vehicles Due to Water Tank Mounting Failure

    Monaco RV is recalling 2,250 recreational vehicles because the water tank mounting system may fail, causing the tank to separate and become a road hazard.

    Product
    R-VISION — R-VISION, MCKENZIE, HOLIDAY RAMBLER TRAIL SPORT, ONYX, RAINIER ASCENT, ALUMA-LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V285000·2013-07-01

    Augusta RV Recalls 2013-2014 FLEX Trailers Due to Awning Motor Defect

    Augusta RV is recalling 36 model year 2013-2014 FLEX recreational trailers because a design change in the power awning motor assembly may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.

    Product
    AUGUSTA — AUGUSTA FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide

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