The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
105
High
243
Moderate
221
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

101–200 of 588

  • ModerateFDA (Drugs)·D-006-2014·2013-11-27

    L. Perrigo Recalls Infants' Acetaminophen Due to Unmarked Dosing Syringes

    L. Perrigo is recalling 108,828 bottles of infants' acetaminophen because some cartons may contain dosing syringes without dose markings.

    Product
    EQUATE PAIN AND FEVER — EQUATE PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0355-2014·2013-11-27

    Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.

    Product
    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0322-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues. The recall affects 19,438 units distributed worldwide.

    Product
    VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (PROT) concentration in cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0220-2014·2013-11-27

    Swanson Black Cumin Seed Capsules Recalled for Mislabeling

    Swanson Health Products is recalling two lots of Black Cumin Seed capsules because they contain White Cumin Seed instead.

    Product
    Swanson, Premium Brand, Full Spectrum Black Cumin Seed (Nigella Sativa) Dietary Supplement capsules, 400 mg, SW1361, UPS 0 87614 11361 6.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0176-2014·2013-11-27

    Bio-Cat Recalls Cellulase Enzyme Blends Due to Chloramphenicol Contamination

    Bio-Cat Inc is recalling Cellulase Enzyme Blends intended for food manufacturing due to potential chloramphenicol contamination.

    Product
    Cellulase Enzyme Blends, bulk, custom blended formulations identified as Cellulase BX and Celluase Conc, packed in boxes or drums ranging from 1 kg to 25 kg, item # CELIND, labeled in part ***Manufactured by BIO-CAT, INC.9117 Three Notch Road Troy, Virginia 22974 Telephone (800)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0354-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.

    Product
    ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0315-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS LAC Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS LAC Slides because slide dispense cartridges may cause dispensing issues.

    Product
    VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 8150112 VITROS LAC Slides quantitatively measure lactate (LAC) concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0366-2014·2013-11-27

    Teleflex Medical Recalls Green Rusch Laryngoscope Blades for Labeling Inconsistency

    Teleflex Medical is recalling 6,200 Green Rusch laryngoscope blades due to a labeling inconsistency. The devices were distributed nationwide.

    Product
    Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0332-2014·2013-11-27

    ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Particulate Matter

    ConMed is recalling 147 Altrus Thermal Tissue Fusion handpieces because they were exposed to higher-than-acceptable particulate matter during manufacture.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0319-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 6,606 units distributed worldwide.

    Product
    VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0295-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product ALC Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product ALC Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 VITROS ALC Slides quantitatively measure ethanol (ALC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-010-2014·2013-11-27

    Greenstone Recalls Spironolactone Tablets Due to Unapproved Manufacturing Site Change

    Greenstone LLC is recalling 2,796 bottles of Spironolactone 25 mg tablets because they were manufactured at an unapproved site, altering the dissolution profile.

    Product
    Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Greenstone LLC, Peapack, NJ 07977, NDC: 59762-5011-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0372-2014·2013-11-27

    Hospira Recalls Symbiq Infuser Batteries Due to Incorrect Model Shipment

    Hospira is recalling 59 Symbiq infuser batteries because the wrong model (E10) was shipped instead of the correct E09 model.

    Product
    *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label found on each battery; *** E10 batteries can be i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0307-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRBM Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides because of slide dispense issues. The slides are used to measure carbamazepine levels in serum and plasma.

    Product
    VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 544 units distributed worldwide.

    Product
    VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0219-2014·2013-11-27

    Best in Nature Eye Care Essence Recalled for Missing Ingredients

    Diamond Nutriceutical, Inc. is recalling Best in Nature Eye Care Essence because FDA testing found the product lacked labeled amounts of Vitamin A and Vitamin C.

    Product
    Best in Nature Brand Eye Care Essence, 100 Capsules. Product labeling reads in part:"Best in Nature Eye Care Essence***Dietary Supplement 100 capsules***Manufactured for: Best in Nature Walnut, CA 91789***www.1688best.com***8 92418 001069 6***".
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0185-2014·2013-11-27

    Nature Made Multivitamin Softgels Recalled Due to Reduced Vitamin Potency

    Pharmavite is voluntarily recalling Nature Made multivitamin softgels because quality tests show Vitamins B1 and B12 are losing potency faster than expected.

    Product
    Multi for Her (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0347-2014·2013-11-27

    Riverpoint Recalls Vilet Surgical Suture Due to Labeling Error

    Riverpoint Medical is recalling 1,932 pieces of Vilet surgical suture because the label incorrectly states the suture is undyed when it is actually violet.

    Product
    Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalm
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0314-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 units distributed worldwide.

    Product
    VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0331-2014·2013-11-27

    ConMed Altrus Thermal Tissue Fusion Handpieces Recalled for Particulate Matter

    ConMed is recalling 65 Altrus Thermal Tissue Fusion handpieces exposed to excessive particulate matter during manufacture, which could cause minor local infections.

    Product
    ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus¿ Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.

    Product
    VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0369-2014·2013-11-27

    Synthes Titanium Trochanteric Fixation Nail Recall for Non-Conforming Blades

    Synthes USA is recalling Titanium Trochanteric Fixation Nail (TFN) Helical Blades due to a potential for non-conforming products to be distributed.

    Product
    Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 units distributed worldwide.

    Product
    VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0292-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ACET Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ACET Slides because of slide dispense issues. The recall affects 16,732 units distributed worldwide.

    Product
    VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0222-2014·2013-11-27

    CTF Brand Tapioca Pearl Pandan Recalled for Missing Ingredient Labeling

    N A Trading Inc is recalling CTF Brand Tapioca Pearl Pandan because the packaging fails to list Artificial Color Yellow No. 5 and Brilliant Blue FD&C No. 1.

    Product
    CTF Brand Tapioca Pearl Pandan (Green Color), 14oz Plastic Bags, Packaged at 50 bags per case. Packaged in plastic heat-sealed pouch. Brand name is CTF with an illustration of a deer. Product labeling reads in part:"C.T.F. Brand TAPIOCA PEARL***EXPORTED: COMBINE THAI FOODS
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0346-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0312-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-014-2014·2013-11-27

    Pfizer Recalls Aldactone Tablets Due to Unapproved Manufacturing Site

    Pfizer is recalling Aldactone (spironolactone) 100 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.

    Product
    ALDACTONE — ALDACTONE (SPIRONOLACTONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0324-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides due to slide dispense issues affecting cartridge functionality.

    Product
    VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bilirubin (TBIL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0338-2014·2013-11-27

    Synovis Recalls Vascu Guard and Dura-Guard Patches Due to Shipping Configuration Issues

    Synovis is recalling Vascu Guard and Dura-Guard patches because specific fluid ounce units shipped in divided cell configurations with a specific revision of the Instructions for Use.

    Product
    Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular reconstruction. Product Code: VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG0106N VG010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0309-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CRP Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive protein (CRP) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated Sy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0301-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS BUN/UREA Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS BUN/UREA Slides because of slide dispense issues. The recall affects units distributed worldwide.

    Product
    VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea (UREA), in serum, plasma, and urine using VITROS 250/350/950/5,1 FS a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Ca Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Ca Slides because of slide dispense issues with the cartridges used to dispense them.

    Product
    VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0313-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Fe Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Fe Slides due to slide dispense issues. The recall affects 37,525 units distributed worldwide.

    Product
    VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 1924547 VITROS Fe Slides quantitatively measure iron (Fe) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0326-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.

    Product
    VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0308-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CREA Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides due to slide dispense issues. The recall affects 364,752 units distributed worldwide.

    Product
    VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.

    Product
    VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0358-2014·2013-11-27

    Wexford Labs Recalls Expired Thymo-Cide Germicidal Detergent

    Wexford Labs is recalling Thymo-Cide germicidal detergent because expired active ingredient was used in its manufacture.

    Product
    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0339-2014·2013-11-27

    Synovis Recalls Dura-Guard and Vascu-Guard Patches Due to Shipping Errors

    Synovis is recalling Dura-Guard and Vascu-Guard patches because specific units were shipped in divided cell configurations with a specific revision of the Instructions for Use.

    Product
    Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0357-2014·2013-11-27

    Zimmer Trinica Anterior Lumbar Plate Instrument Tray Recall for Sterilization Issues

    Zimmer Spine is recalling Trinica ALP Instrument Trays because ratchet handles may not sterilize effectively due to tray design interference.

    Product
    Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of shapes and sizes of plates and screws. The Trinica Anterior Lumbar Plate System i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0356-2014·2013-11-27

    Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue

    Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.

    Product
    ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx):
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0328-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 85,646 units distributed worldwide.

    Product
    VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0327-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 31,395 units distributed worldwide.

    Product
    VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (UPRO) concentration in urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0303-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS CHE Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS CHE Slides because of slide dispense issues. The recall affects 11,135 units distributed worldwide.

    Product
    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0300-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0368-2014·2013-11-27

    Philips EPIQ 7 Ultrasound System Recalled for Date Format Calculation Errors

    Philips is recalling EPIQ 7 Ultrasound Systems because using the International System Date Format may cause calculation errors in Gestational Age and Established Due Date.

    Product
    EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0323-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS SALI Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS SALI Slides because the associated Slide Dispense cartridges have slide dispense issues.

    Product
    VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0310-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0337-2014·2013-11-27

    GE Healthcare Recalls Centricity Perinatal and Intensive Care Software

    GE Healthcare is recalling Centricity Perinatal and Intensive Care software due to a rare network issue that may temporarily prevent users from accessing patient rosters.

    Product
    Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, critical care units including Neonatal Intensive Care Units (NICU), and may also
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0306-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 8001133 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-002-2014·2013-11-27

    Boehringer Ingelheim Recalls Oxcarbazepine Oral Suspension Due to Resuspension Issues

    Boehringer Ingelheim is recalling 10,267 bottles of Oxcarbazepine Oral Suspension because the product failed to meet resuspendability requirements.

    Product
    Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringer Ingelheim, Roxane Laboratories, Inc. Columbus, Ohio 43216, NDC 0054-0199-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2014·2013-11-27

    Ortho-Clinical Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0294-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry ALB Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry ALB Slides due to slide dispense issues. The recall affects 16,583 units distributed worldwide.

    Product
    VITROS Chemistry Products ALB Slides, 90 slides/pack; catalog number 1988211 VITROS ALB Slides quantitatively measure (ALB) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0336-2014·2013-11-27

    Terumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts

    Terumo CVS is recalling nine Vascutek Gelsoft vascular grafts because they were incorrectly labeled with the wrong diameter.

    Product
    Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Length 15cm***Manufactured By***VASCUTEK Ltd. a TERUMO Company Newmains Avenue Inc
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0201-2014·2013-11-27

    American Beverage Corp Recalls Big Juicy Fruit Punch Drink Bottles

    American Beverage Corp is recalling Big Juicy Fruit Punch Drink in 10 oz plastic bottles due to a potential choking hazard from the sports cap.

    Product
    Big Juicy Fruit Punch Drink in 10 oz plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0184-2014·2013-11-27

    Nature Made Multivitamin Softgels Recalled Due to Reduced Vitamin Potency

    Pharmavite is voluntarily recalling Nature Made multivitamin softgels because quality tests show Vitamins B1 and B12 are losing potency faster than expected.

    Product
    Multi Complete (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case.+++Multi Complete (club size) (Full Strength Mini and Multi Softgels), 180 Count Bottle. 20 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMEN
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0316-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Li Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Li Slides due to slide dispense issues.

    Product
    VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 1632660 VITROS Li Slides quantitatively measure lithium (Li) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0187-2014·2013-11-27

    Nature Made Multi Vitamins Recalled Due to Reduced Potency

    Pharmavite is recalling Nature Made Multi vitamins because quality tests show Vitamins B1 and B12 are losing potency faster than expected.

    Product
    Multi For Him (Full Strength Mini and Multi Softgels), 60 Count Bottle. 24 units per master case. Product labeling reads in part:"NatureMade***DIETARY SUPPLEMENT 60 SOFTGELS***Distributed by: Nature Made Nutritional Products Mission Hills, CA 91346-9606, U.S.A 1-800-276-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-005-2014·2013-11-27

    L. Perrigo Recalls Infants' Pain and Fever Due to Unmarked Syringes

    L. Perrigo Co. is recalling 27,504 bottles of TopCare Infants' Pain and Fever because some cartons may contain dosing syringes without dose markings.

    Product
    TOPCARE INFANTS PAIN AND FEVER — TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2014·2013-11-27

    Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk

    Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.

    Product
    THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-008-2014·2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

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

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Body Oil), 118.28 mL (4 fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, Florida 32773, NDC 28105-150-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-007-2014·2013-11-27

    Hill Dermaceuticals Recalls Subpotent Fluocinolone Acetonide Topical Oil

    Hill Dermaceuticals is recalling specific lots of Derma-Smoothe/FS topical oil because routine testing found the active ingredient to be subpotent.

    Product
    Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil (Scalp Oil), 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
  • HighCPSC·14031·2013-11-26

    American Boy and Girl Recalls Infant Sandals Due to Choking Hazard

    American Boy and Girl is recalling about 1,300 infant girl sandals sold at Meijer stores because the top strap can detach, posing a choking hazard to children.

    Product
    Girl's "Susan" Sandals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14033·2013-11-26

    Burley Recalls Tailwind Bicycle Racks for Trailercycles Due to Fall Hazard

    Burley Design is recalling Tailwind bicycle racks for trailercycles because the top portion can break, causing the trailercycle to disconnect and posing a fall hazard.

    Product
    Tailwind bicycle racks for trailercycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V584000·2013-11-25

    Ford Recalls 2013 Escape Vehicles for Fuel Line Fire Risk

    Ford is recalling 2013 Escape vehicles with 1.6L engines because a fuel line may have been installed incorrectly during a prior repair, posing a fire risk.

    Product
    FORD — FORD ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V599000·2013-11-25

    Wells Cargo Trailer Recall for Door Lock Jamming Risk

    Wells Industries is recalling 2006-2013 Wells Cargo trailers equipped with Fastec door locks because the deadbolt may jam, potentially trapping occupants inside.

    Product
    WELLS CARGO — WELLS CARGO CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V598000·2013-11-25

    Wells Cargo Recalls Trailers Due to Door Lock Jamming Risk

    Wells Cargo is recalling 2006-2013 cargo trailers because a door lock defect could jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    WELLS CARGO — WELLS CARGO CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V600000·2013-11-25

    Haulmark Travel Trailer Recall for Door Lock Jamming Risk

    Haulmark is recalling 2006-2013 travel trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.

    Product
    HAULMARK — HAULMARK TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V593000·2013-11-25

    Peterbilt Trucks Recalled for Missing Certification Label Information

    PACCAR is recalling 2004-2013 Peterbilt trucks because missing certification label information may lead to axle overloading or improper tire installation, increasing crash risk.

    Product
    PETERBILT — PETERBILT 385, 389, 386, 388
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V589000·2013-11-22

    Maserati Recalls 2014 Quattroporte GTS for Wiring Fire Risk

    Maserati is recalling 2014 Quattroporte GTS vehicles due to a wiring defect that could cause a fire or vehicle stall.

    Product
    MASERATI — MASERATI QUATTROPORTE GTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V569000·2013-11-22

    Volkswagen Recalls 2009-2011 Tiguan Vehicles for Melted Fuse Holder

    Volkswagen is recalling 2009-2011 Tiguan vehicles because a fuse holder may melt, causing partial loss of exterior lights and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V585000·2013-11-22

    Jayco, Starcraft, and Entegra Towable Trailer Door Lock Recall

    Jayco is recalling 2006-2014 towable trailers equipped with Fastec door locks because the key can jam the deadbolt, potentially trapping occupants inside.

    Product
    JAYCO — JAYCO, STARCRAFT, ENTEGRA TOWABLE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V591000·2013-11-22

    Volvo Bus 9700 Recalled for Insufficient Emergency Exit Windows

    Volvo is recalling 10 wheelchair-accessible 2009-2010 9700 motor coaches that lack required emergency exit windows, posing an injury risk during emergencies.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·14028·2013-11-21

    Angelcare Baby Monitors Recalled for Infant Strangulation Hazard

    Angelcare is recalling about 600,000 baby monitors in the U.S. and 182,173 in Canada due to a strangulation risk from the sensor pad cord. Two infant deaths have been reported.

    Product
    Angelcare Movement and Sound Baby Monitors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14029·2013-11-21

    Cuisinart Recalls 7-Cup Food Processors Due to Laceration Hazard

    Cuisinart is recalling 7-cup food processors because a loose slicing disc can break the cover, posing a laceration hazard to consumers.

    Product
    Cuisinart 7-cup food processors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V586000·2013-11-21

    Carry-On Enclosed Cargo Trailer Recall for Door Lock Jamming Risk

    Carry-On is recalling 2006-2013 enclosed cargo trailers with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    CARRY-ON — CARRY-ON ENCLOSED CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V590000·2013-11-21

    Collins Recalls 2013 School Buses Due to Seat Belt Buckle Defect

    Collins Bus Corporation is recalling 333 model year 2013 school buses because seat belt buckles may fail to release, hindering emergency egress.

    Product
    COLLINS — COLLINS, COLLINS MID BUS, COLLINS CORBEIL DE516WR, DE516, DH416WR, DH400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V587000·2013-11-21

    HL Enterprise Recalls 2011-2013 Trailers With Defective Door Locks

    HL Enterprise is recalling 716 model year 2011-2013 travel, fifth-wheel, and destination trailers equipped with Fastec-brand door locks that may jam, potentially trapping occupants inside.

    Product
    BRIDGEVIEW — BRIDGEVIEW, GEORGIAN BAY, HARBORVIEW TRAVEL/5TH/DESTINATION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14027·2013-11-21

    ElliptiGO Recalls Outdoor Elliptical Cycles Due to Fall Hazard

    ElliptiGO is recalling about 7,200 outdoor elliptical cycles in the U.S. and Canada because the front fork or drive arm axles can detach, posing a fall hazard.

    Product
    ElliptiGO outdoor elliptical cycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1732-2013·2013-11-20

    Priester's Pecans Roasted Nuts Recalled for Salmonella Risk

    Priester Pecan Company is recalling Fancy Roasted Nuts because pistachios supplied by ARO may be contaminated with Salmonella.

    Product
    PRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1731-2013·2013-11-20

    Priester's Pecans Nutty Favorites Recalled for Salmonella Risk

    Priester Pecan Company is recalling Nutty Favorites Assortments because supplied pistachios may be contaminated with Salmonella.

    Product
    PRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V588000·2013-11-20

    Nissan Recalls 2014 Infiniti Q50 for Steering Software Defect

    Nissan is recalling 2014 Infiniti Q50 vehicles because freezing temperatures may disable electric steering and delay the mechanical backup, increasing crash risk.

    Product
    INFINITI — INFINITI Q50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0156-2014·2013-11-20

    Empirical Labs Recalls P&L Enzymes Due to Chloramphenicol Contamination

    Empirical Labs is recalling specific lots of P&L Enzymes dietary supplements due to potential adulteration with chloramphenicol.

    Product
    Empirical Labs Building Health P&L Enzymes; 180 Capsules Dietary Supplement
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0172-2014·2013-11-20

    Aunt Jemima Grits and Corn Meal Recalled for Aflatoxin Levels

    Quaker Foods and Snacks North America is recalling specific lots of Aunt Jemima Quick Grits and Corn Meal Mix because they contain aflatoxin above legal limits.

    Product
    White grits packaged in a paper bag labeled in part: Smooth & Creamy; Aunt Jemima; Quick GRITS; Cooks in about 5 minutes; ENRICHED WHITE HOMINY; NET WT 36.8 oz. (2 lb. 4.8 oz.) 1043g
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0174-2014·2013-11-20

    GoPicnic Meal Kits Recalled for Undeclared Milk Allergen

    GoPicnic is recalling Black Bean Dip & Plantain Chips meal kits because the included chocolates may contain undeclared milk allergens.

    Product
    GoPicnic Black Bean Dip & Plantain Chips; ready-to-eat meal kit with professor zim zam's extraordinary sweets dark chocolate with orange packaged in paperboard container; NET WT 4.2 OZ (116.2g); distributed by gopicnic brands, inc.; chicago, il 60613; www.gopicnic.com;
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0280-2014·2013-11-20

    Stryker Recalls Acetabular Pressurizers Due to Cracked Assemblies

    Stryker is recalling 87 boxes of Acetabular Pressurizers because cracked assemblies may release during cement application.

    Product
    Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-52
    Category
    Medical Device
    Distribution
    Distributed nationwide

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