The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
256
High
403
Moderate
156
Low
23

Of the 896 recalls this month scored against our rubric, 6% are Critical, 29% are Severe.

801–896 of 896

  • HighFDA (Devices)·Z-1776-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 24 boxes of Delicot non-xray sponges because defective packaging compromises sterility.

    Product
    American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1755-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 182 boxes of strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall affects 4 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 7 boxes of Uniqcot sponges because defective packaging may compromise sterility. The product was distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1728-2016·2016-06-01

    American Surgical Recalls Sponges Due to Packaging Sterility Defect

    American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2016·2016-06-01

    American Surgical Tonsil Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling tonsil sponges due to packaging defects that compromise sterility. The recall covers four boxes distributed worldwide.

    Product
    American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1749-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2016·2016-06-01

    Biomet Recalls Orthopedic Instruments Due to Sterile Packaging Seal Defect

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 78 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility. The product is distributed worldwide.

    Product
    American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V389000·2016-06-01

    Kia Recalls Sedona Vehicles Due to Hood Latch Binding Issue

    Kia is recalling 2006-2014 Sedona vehicles because the secondary hood latch may bind, allowing the hood to open while driving and increasing crash risk.

    Product
    KIA — KIA SEDONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2016·2016-06-01

    American Surgical Recalls Americot Blue Sponges Due to Packaging Defects

    American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1395-2016·2016-06-01

    Kool-Aid Jammers Cherry Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Cherry due to the possible presence of glass fragments.

    Product
    Kool-Aid Jammers Cherry packaged in a red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1758-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defects

    American Surgical Company is recalling specific lots of strung cotton balls because defective packaging may compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes distributed worldwide.

    Product
    American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1733-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 boxes distributed worldwide.

    Product
    American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1396-2016·2016-06-01

    Kool-Aid Jammers Tropical Punch Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Tropical Punch due to the possible presence of glass fragments.

    Product
    Kool-Aid Jammers Tropical Punch packaged in a red blue and purple box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1754-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Sterility Compromise

    American Surgical Company is recalling 13 boxes of strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2016·2016-06-01

    Mighty Leaf Organic Ginger Peach Iced Tea Recalled for Salmonella Risk

    Mighty Leaf Tea is recalling Organic Ginger Peach Iced Tea due to potential Salmonella contamination identified by a supplier.

    Product
    Mighty Leaf Tea Company Organic Ginger Peach Iced Tea; 100/1 oz. per case Item number 60001. UPC: 00656252600019
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-1743-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V393000·2016-06-01

    Volvo Recalls 2017 VNL Trucks Due to Engine Stall Risk

    Volvo Trucks North America is recalling 136 model year 2017 VNL trucks because an engine control module defect may cause an unexpected engine stall, increasing crash risk.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1711-2016·2016-06-01

    Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage

    Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.

    Product
    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 113 boxes of Delicot 6 mm x 50 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 6 mm x 50 mm Ref Number: 63-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defect

    American Surgical Company is recalling 35 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/2" x 1" Ref Number: 20-05S Product Usage: Neurosurgical and Nonneurosurgical Sponges Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling 39 boxes of Uniqcot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Uniqcot 1/4" x 1/4" Ref Number: 67-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Sterility Compromise

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers three boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 3" Ref Number: 60-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 38 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 2" Ref Number: 60-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The affected lot is distributed worldwide.

    Product
    American Surgical Telfa 3/4" x 3" Ref Number: 80-11 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1756-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 70 units of strung cotton balls because defective packaging may compromise sterility.

    Product
    American Surgical Cotton Balls-Strung 3/4" Ref Number: 30-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1738-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 5 mm x 13 mm (Glassine) Ref Number: 23-02G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multiple component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1394-2016·2016-06-01

    Kool-Aid Jammers Grape Recalled for Possible Glass Fragments

    Kraft Heinz Foods is recalling Kool-Aid Jammers Grape due to the possible presence of glass fragments. Consumers should stop using the product.

    Product
    Kool-Aid Jammers Grape packaged in a purple and red box with white lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1802-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Defects Compromising Sterility

    American Surgical Company is recalling Telfa neurosurgical and nonneurosurgical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Telfa 1/2" x 1.5" Ref Number: 80-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall affects 266 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 315 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 9 mm x 50 mm Ref Number: 63-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2016·2016-06-01

    American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Delicot X sponges because defective packaging may compromise sterility. The recall affects worldwide distribution.

    Product
    American Surgical Delicot X 9 mm x 50 mm Ref Number: 63x07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V388000·2016-06-01

    Terex Advance Recalls 2016 Concrete Mixers Due to Engine Stall Risk

    Terex Advance is recalling 2016 Front Discharge Concrete Mixers because a faulty engine control module may cause the engine to stall unexpectedly, increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FRONT DISCHARGE CONCRETE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Telfa 1" x 1" neurosurgical and nonneurosurgical sponges because defective packaging compromises sterility.

    Product
    American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 15 boxes of Americot Blue sponges because defective packaging compromises sterility.

    Product
    American Surgical Americot Blue 3/8" x 2" Ref Number: 20-26S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 33 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 20 mm x 60 mm Ref Number: 23-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V386000·2016-06-01

    Forest River Recalls Transit Buses with Defective Wheelchair Lifts

    Forest River is recalling specific transit buses equipped with Ricon wheelchair lifts due to a risk of platform separation and injury to operators.

    Product
    GLAVAL BUS — GLAVAL BUS, ELKHART, STARCRAFT BUS UNIVERSAL, ECG4, ALLSTAR XL, ALLSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1403-2016·2016-06-01

    Simply Delicious Recalls Lemon Poppyseed Oat Bars Due to Mispackaging

    Simply Delicious is recalling Lemon Poppyseed Oat Bars because they were mispackaged with Coconut bars. The recall covers 142 cases distributed nationwide.

    Product
    Bobo's Oat Bars, Gluten Free, Lemon Poppyseed, Net Weight 3 oz (85g), packaged in clear plastic, 12 bars per sleeve, also sold as individual units. Manufactured by Simply Delicious, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2016·2016-06-01

    American Surgical Policot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Policot sponges because defective packaging may compromise sterility. The recall covers two boxes distributed worldwide.

    Product
    American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 24 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 3/8" x 3/8" Ref Number: 20-22S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2016·2016-06-01

    American Surgical Telfa Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Telfa neurosurgical sponges because defective packaging may compromise sterility.

    Product
    American Surgical Telfa 3/8" x 3" Ref Number: 80-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 3 boxes distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 2" Ref Number: 67-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1/4" x 1/4" Ref Number: 60-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 97 boxes of Delicot 5 mm x 13 mm sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2016·2016-06-01

    American Surgical Cotton Balls Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 10 boxes of non-strung cotton balls due to packaging defects that compromise sterility.

    Product
    American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2016·2016-06-01

    Biomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.

    Product
    Various trauma and sports medicine instruments and implants. Arthroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 22 boxes of Ultracot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Ultracot 15 mm x 20 mm Ref Number: 23-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1392-2016·2016-06-01

    Kraft Heinz Recalls CapriSun Tropical Punch Due to Possible Glass Fragments

    Kraft Heinz is recalling CapriSun tropical punch due to the possible presence of glass fragments. Consumers should stop using the product and contact the company for a refund.

    Product
    CapriSun tropical punch packaged in a blue and white box with pictures of fruit and white and black lettering.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1775-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 287 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 5 mm x 8 mm Ref Number: 63-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2016·2016-06-01

    American Surgical Cotton Balls Recalled Due to Packaging Sterility Defect

    American Surgical Company is recalling 7 boxes of non-strung cotton balls due to packaging defects that compromise sterility. The affected lots were distributed worldwide.

    Product
    American Surgical Cotton Balls-Non-Strung 1/8" Ref Number: 31-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defect

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall affects 262 boxes distributed worldwide.

    Product
    American Surgical Americot Blue 1/2" x 1/2" Ref Number: 20-04S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1723-2016·2016-06-01

    American Surgical Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling Americot Blue sponges because defective packaging may compromise sterility. The recall covers 54 cases distributed worldwide.

    Product
    American Surgical Americot Blue 1/4" x 1/4" Ref Number: 20-01S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1771-2016·2016-06-01

    American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 209 boxes distributed worldwide.

    Product
    American Surgical Ray-Cot 1" x 3" Ref Number: 60-13 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2016·2016-06-01

    GE Healthcare Discovery IGS 740 Systems Recalled for Image Loss

    GE Medical Systems is recalling 25 Discovery IGS 740 systems due to potential non-recoverable loss of image acquisition during procedures.

    Product
    GE Healthcare, Discovery IGS 740. Indicated for use in generating fluoroscopic and rotational images of human anatomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 27 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 5 mm x 8 mm Ref Number: 63-01J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers products distributed in the US and 20 other countries.

    Product
    American Surgical Ultracot 30 mm x 70 mm Ref Number: 23-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1727-2016·2016-06-01

    American Surgical Americot Blue Sponges Recalled for Packaging Defects

    American Surgical Company is recalling 33 boxes of Americot Blue sponges because defective packaging may compromise sterility.

    Product
    American Surgical Americot Blue 1/2" x 3" Ref Number: 20-07S Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1737-2016·2016-06-01

    American Surgical Ultracot Sponges Recalled for Packaging Defect Compromising Sterility

    American Surgical Company is recalling 11 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.

    Product
    American Surgical Ultracot 5 mm x 8 mm (Glassine) Ref Number: 23-01G Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0874-2016·2016-06-01

    Akorn Recalls ORIS Chlorhexidine Oral Rinse Due to Impurity

    Akorn, Inc. is recalling ORIS (chlorhexidine gluconate) oral rinse because multiple batches failed impurity specifications.

    Product
    ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1389-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement Due to Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Mango Orange , 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1388-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet FDA dietary ingredient definitions.

    Product
    Undisputed , all lot codes, Flavors: Juicy Pineapple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1797-2016·2016-06-01

    American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 15 cases distributed worldwide.

    Product
    American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1385-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Improper Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors:Fruit Punch, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1722-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 689 boxes of Delicot sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot 30mm x 70mm Ref: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1788-2016·2016-06-01

    American Surgical Delicot-J Sponges Recalled for Packaging Sterility Defect

    American Surgical Company is recalling 33 boxes of Delicot-J sponges because defective packaging may compromise sterility.

    Product
    American Surgical Delicot-J 13 mm x 60 mm Ref Number: 63-08J (Japan only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1398-2016·2016-06-01

    Sinco Recalls Archer Farms Frozen Pizza Due to Plastic Contamination

    Sinco is recalling Archer Farms Greek-Inspired Spinach & Feta Cheese Artisan Pizza because a consumer found a small piece of gray plastic in the product.

    Product
    archer farms Greek-Inspired Spinach & Feta Cheese ARTISAN PIZZA, NET WT 14.9 OZ (425g). UPC Code: 0-85239-30714-4. Pizza is frozen.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2016·2016-06-01

    Biomet PerFuse Decompression Instrument Recall Due to Missing Parts

    Biomet, Inc. is recalling 22 PerFuse Decompression Instruments because missing Trocar and Plunger Assemblies could delay surgery by more than 30 minutes.

    Product
    PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1712-2016·2016-06-01

    RayStation Therapy Treatment Planning Software Recalled for Synchronization Bug

    RaySearch Laboratories is recalling RayStation Therapy Treatment Planning System software due to a bug that can cause views to become unsynchronized with stored data.

    Product
    RayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and 4.7., designed for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Drugs)·D-0858-2016·2016-06-01

    Lymol Medical Recalls Sclerosol Intrapleural Aerosol Due to Defective Valve

    Lymol Medical is recalling Sclerosol Intrapleural Aerosol because a defective stem valve may cause the canister to leak propellant, resulting in no drug or an inadequate dose being delivered.

    Product
    Sclerosol Intrapleural Aerosol (sterile talc powder), Intrapleural administration, 4 g Canister, Rx Only, Distributed by: Bryan Corporation, Woburn, MA 01801, USA, NDC 63256-100-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1720-2016·2016-06-01

    Accriva APTT Cuvettes Recalled Due to Mis-positioned Reagent

    Accriva Diagnostics is recalling APTT Cuvettes for the Hemochron Jr. system because the clot activating reagent may be mis-positioned or absent, causing test errors or high results.

    Product
    Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0857-2016·2016-06-01

    Pfizer Recalls Zoloft Tablets Due to Thick Tablet Specifications

    Pfizer is recalling 68,214 bottles of Zoloft 100 mg tablets because some tablets were thicker than specifications. The recall covers nationwide distribution and Puerto Rico.

    Product
    Zoloft (sertraline HCl) tablets, 100 mg*, 30 count bottles, Rx only, Distributed by Roerig, Division of Pfizer, Inc., NY NY 10017, NDC 0049-4910-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1386-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Watermelon, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1710-2016·2016-06-01

    Synthes 3.2 mm Radiolucent Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.

    Product
    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1387-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling all lot codes of Undisputed dietary supplements because they contain Acacia rigidula, an ingredient that does not meet FDA dietary ingredient definitions.

    Product
    Undisputed , all lot codes, Flavors: Lemon Lime, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1367-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement for Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling all lot codes of Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Blue Raspberry, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1704-2016·2016-06-01

    Leica Calretinin Antibody Recalled for Reduced Staining Performance

    Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.

    Product
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1708-2016·2016-06-01

    Stryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters

    Stryker Sustainability Solutions is recalling 18 reprocessed diagnostic electrophysiology catheters because they were mislabeled for size.

    Product
    Reprocessed Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters; Model #: 401450, 401877. Indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1790-2016·2016-06-01

    American Surgical Delicot Sponges Recalled for Packaging Sterility Defects

    American Surgical Company is recalling 338 boxes of Delicot sponges because defective packaging compromises sterility. The products were distributed worldwide.

    Product
    American Surgical Delicot 30 mm x 70 mm Ref Number: 63-10 Product Usage: Neurosurgical and Nonneurosurgical Sponges
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2016·2016-06-01

    Volcano Cardiology Imaging Systems Recalled for Network Compatibility Reboot Issue

    Volcano Corporation is recalling specific cardiology imaging systems due to a software incompatibility that can cause unexpected reboots when encountering specific hospital network data.

    Product
    Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2016·2016-06-01

    Synthes 3.2 mm Drill Bits Recalled for Sterile Packaging Compromise

    Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture the sterile barrier.

    Product
    3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2016·2016-06-01

    Akorn Recalls Chlorhexidine Gluconate Oral Rinse Due to Unknown Impurity

    Akorn, Inc. is recalling Chlorhexidine gluconate oral rinse due to an out-of-specification result for an unknown impurity.

    Product
    Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1390-2016·2016-06-01

    Nubreed Nutrition Recalls Undisputed Dietary Supplement Due to Non-Compliant Ingredient

    Nubreed Nutrition is voluntarily recalling Undisputed dietary supplements because they contain Acacia rigidula, which does not meet the definition of a dietary ingredient.

    Product
    Undisputed , all lot codes, Flavors: Sour Apple, 330 grams packed in 20oz HDPE White Plastic Container, The product was sold in white bottles with a white cap, containing forty (40) powder servings; 12 /case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1705-2016·2016-06-01

    Elekta iGUIDE System Software Recall for Radiotherapy Positioning Errors

    Elekta, Inc. is recalling 20 iGUIDE Systems due to a software issue that may allow pre-treatment imaging to be performed before the HexaPOD is in the correct position.

    Product
    iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1402-2016·2016-06-01

    Zochem Recalls Zinc Oxide Powder Contaminated with Iron

    Zochem Inc. is recalling zinc oxide powder lots contaminated with iron. The product is used in manufacturing dietary supplements and drugs.

    Product
    Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-1830-2016·2016-06-01

    Roche Recalls Hungarian Instructions for cobas EGFR Mutation Test Kits

    Roche is recalling 8 kits of cobas EGFR Mutation Test v2 and cfDNA Sample Preparation due to errors in the Hungarian translated instructions for use.

    Product
    cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
    Category
    Medical Device
    Distribution
    0 states

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