The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
272
High
309
Moderate
311
Low
64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

501–600 of 1028

  • HighFDA (Food)·F-0664-2015·2014-12-17

    Whole Foods Market Crispy BBQ Peach Tempeh Recalled for Listeria Risk

    Whole Foods Market is recalling Crispy BBQ Peach Tempeh due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Crispy BBQ Peach Tempeh, UPC/PLU 20253800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0655-2015·2014-12-17

    Whole Foods Market Recalls Cobbler Peach for Listeria Risk

    Whole Foods Market is recalling Cobbler Peach products due to potential contamination with Listeria monocytogenes. The products were sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Cobbler Peach, UPC/PLU 20136000000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0673-2015·2014-12-17

    Whole Foods Market Peach Fruit Crisp Recalled for Listeria Risk

    Whole Foods Market is recalling Peach Fruit Crisp due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peach Fruit Crisp, UPC/PLU 21222100000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0668-2015·2014-12-17

    Whole Foods Grilled Salmon Recalled for Listeria Contamination Risk

    Whole Foods Market is recalling Grilled Salmon with Peach Rosemary Jam due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Grilled Salmon with Peach Rosemary Jam, UPC/PLU 20255600000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0694-2015·2014-12-17

    Whole Foods Market Recalls Cold Pressed Juice Due to Listeria Risk

    Whole Foods Market is recalling Peachy Keen Cold Pressed 16 oz juice due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peachy Keen Cold Pressed 16 oz, UPC/PLU 29682700000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0680-2015·2014-12-17

    Whole Foods Market Recalls Caramelized Peach with Ricotta for Listeria Risk

    Whole Foods Market is recalling Caramelized Peach with Ricotta due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Caramelized Peach with Ricotta, UPC/PLU 20256300000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0647-2015·2014-12-17

    Whole Foods Market Peaches n Cream Cake Recalled for Listeria Risk

    Whole Foods Market is recalling Peaches n Cream Cakes due to potential Listeria monocytogenes contamination. The products were sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peaches n Cream Cake 6", UPC/PLU 20733500000; Whole Foods Market Peaches n Cream Cake 8", UPC/PLU 20733600000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0657-2015·2014-12-17

    Whole Foods Market Recalls Blueberry Parfait for Listeria Risk

    Whole Foods Market is recalling HSH Parfait-Blueberry due to potential contamination with Listeria monocytogenes. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market HSH Parfait-Blueberry, UPC/PLU 20659600000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0650-2015·2014-12-17

    Whole Foods Market Peach Cobbler Dessert Bar Recalled for Listeria Risk

    Whole Foods Market is recalling Peach Cobbler Dessert Bars due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market WFM Dess Bar Cobbler-Peach, UPC/PLU 20643100000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0645-2015·2014-12-17

    Whole Foods Market Recalls Heirloom Tomato and Peach Salad for Listeria Risk

    Whole Foods Market is recalling Heirloom Tomato & Peach Salad due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Heirloom Tomato & Peach Salad, UPC/PLU 28353400000/83534; UPC/PLU 20264900000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0627-2015·2014-12-17

    Whole Foods Market Recalls Grill Tray Peaches Due to Listeria Risk

    Whole Foods Market is recalling FM Grill Tray Peaches because they may be contaminated with Listeria monocytogenes. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market FM Grill Tray Peach, UPC/PLU 025994200000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0686-2015·2014-12-17

    Whole Foods Market Recalls Peach Basil Stuffed Salmon for Listeria Risk

    Whole Foods Market is recalling Peach Basil Stuffed Salmon due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peach Basil Stuffed Salmon, UPC/PLU 25179600000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0682-2015·2014-12-17

    Whole Foods Market Sangria Mix Recalled for Listeria Risk

    Whole Foods Market is recalling its FM Sangria Mix due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market FM Sangria Mix LG, UPC/PLU 29690300000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0708-2015·2014-12-17

    Whole Foods Market Vegan Pumpkin Pie Recalled for Undeclared Walnuts

    Whole Foods Market is recalling 1,144 vegan pumpkin pies because they contain walnuts that are not listed on the label.

    Product
    Whole Foods Market 9 inch Vegan Pumpkin Pie (32 oz) and 1/2 Vegan Pumpkin Pie (15 oz), packaged in both clear, clamshell packaging and brown, Kraft paper boxes. Distributed by Whole Foods Market. UPCs 24917101099 and 24917300699.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0687-2015·2014-12-17

    Whole Foods Market Recalls Chipotle Peach Turkey for Listeria Risk

    Whole Foods Market is recalling Chipotle Peach Turkey due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Chipotle Peach Turkey, UPC/PLU 29966100000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0683-2015·2014-12-17

    Whole Foods Market Salmon Fillet with Peach Salsa Recalled for Listeria Risk

    Whole Foods Market is recalling Salmon Fillet with Peach Salsa due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Salmon Fillet with Peach Salsa, UPC/PLU 29913800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0667-2015·2014-12-17

    Whole Foods Grilled Salmon Recalled for Listeria Risk

    Whole Foods Market is recalling Grilled Salmon with Peach Ginger Jam due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Grilled Salmon with Peach Ginger Jam, UPC/PLU 20217400000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0697-2015·2014-12-17

    Whole Foods Market Salsa Peach and Cucumber Recalled for Listeria Risk

    Whole Foods Market is recalling Salsa Peach and Cucumber due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Salsa Peach and Cucumber, UPC/PLU 29648300000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0631-2015·2014-12-17

    Whole Foods Market Peach Chutney Recalled for Listeria Risk

    Whole Foods Market is recalling HSH Peach Chutney due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market HSH Peach Chutney, UPC/PLU 22935500000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0691-2015·2014-12-17

    Whole Foods Market Peach Goat Medallion Recalled for Listeria Risk

    Whole Foods Market is recalling Peach Goat Medallions due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peach Goat Medallion, UPC/PLU 29535400000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0561-2015·2014-12-17

    Pfm Medical Recalls ASEPT Pleural Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling ASEPT Pleural Drainage Systems because they may exceed USP limits for bacterial endotoxin. The recall affects 120 units distributed in the US and internationally.

    Product
    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2015·2014-12-17

    Snug Seat Recalls Crocodile Size 3 Walking Aids Due to Bolt Failure

    Snug Seat Inc is recalling 726 Crocodile size 3 walking aids because bolts securing the handles could break, causing the handles to dislodge.

    Product
    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2015·2014-12-17

    PFM Medical Recalls Micro Introducer Kits Due to Bacterial Endotoxin Limits

    PFM Medical is recalling 100 units of Micro Introducer Kits because they may exceed USP limits for bacterial endotoxin. The devices are used for introducing therapeutic devices like PICCs.

    Product
    Micro Introducer Kit, 5F Micro Introducer Kit, Ref No. M4005 Product Usage: These introducers are used for the percutaneous introduction of therapeutic devices, such as PICCS. The PFM CT PICC catheter is indicated for short or long term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0567-2015·2014-12-17

    PFM Medical Recalls Veta Peritoneal Catheter Kits for Bacterial Endotoxin

    PFM Medical is recalling Veta Peritoneal Catheter Kits because they may exceed USP limits for bacterial endotoxin.

    Product
    Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2015·2014-12-17

    PFM Medical Recalls Thoracentesis and Paracentesis Procedure Trays

    PFM Medical is recalling 75 units of Thoracentesis & Paracentesis Procedure Trays because they may exceed USP limits for bacterial endotoxin.

    Product
    Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2015·2014-12-17

    Pfm Medical Recalls Rapid Centesis Catheters Due to Bacterial Endotoxin

    Pfm Medical Inc is recalling Rapid Centesis Catheters because they may exceed USP limits for bacterial endotoxin. The recall affects 480 units distributed in the US and abroad.

    Product
    Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0568-2015·2014-12-17

    PFM Medical Recalls ASEPT Drainage Bags Due to Bacterial Endotoxin Concerns

    PFM Medical is recalling ASEPT 2000 ml Drainage Bags because they may exceed USP limits for bacterial endotoxin. The recall affects 370 units distributed in the US and internationally.

    Product
    ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0698-2015·2014-12-17

    Whole Foods Market Peachy Palmer Peaches Recalled for Listeria Risk

    Whole Foods Market is recalling Peachy Palmer peaches due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Peachy Palmer, UPC/PLU 15766
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0642-2015·2014-12-17

    Whole Foods Market Recalls Fruit Tarts Due to Listeria Risk

    Whole Foods Market is recalling various fruit tarts because they may be contaminated with Listeria monocytogenes. The products were sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Tart Large Square Fruit, UPC/PLU 28893200000; Whole Foods Market Tart Fruit Large, UPC/PLU 20189700000; Whole Foods Market Tart Fruit Large Square, UPC/PLU 20611000000; Whole Foods Market Tart Fruit Medium, UPC/PLU 26255; Whole Foods Market Tart Fruit Medium
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0679-2015·2014-12-17

    Whole Foods Market Caramelized Peach Recalled for Listeria Risk

    Whole Foods Market is recalling Caramelized Peach products due to potential contamination with Listeria monocytogenes. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Caramelized Peach, UPC/PLU 20256200000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0630-2015·2014-12-17

    Whole Foods Grilled Peaches Recalled for Potential Listeria Contamination

    Whole Foods Market is recalling Grilled Peaches due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Grilled Peaches, UPC/PLU 22703900000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0589-2015·2014-12-17

    Smith & Nephew Recalls Legion Knee Prosthesis Due to Undersized Stem Taper

    Smith & Nephew is recalling 24 units of the Legion COCR Constrained Femoral Component because the stem taper is undersized and the gauge point is not deep enough.

    Product
    LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2015·2014-12-17

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negative Risk

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement because it may cause false negative Legionella test results.

    Product
    Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0651-2015·2014-12-17

    Whole Foods Market Peach Crumble Dessert Bar Recalled for Listeria Risk

    Whole Foods Market is recalling Peach Crumble Dessert Bars due to potential Listeria monocytogenes contamination. Consumers should check their pantries for the affected product.

    Product
    Whole Foods Market WFM Dess Bar-Peach Crumble, UPC/PLU 20666800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0643-2015·2014-12-17

    Whole Foods Market Summer Splash Recalled for Listeria Risk

    Whole Foods Market is recalling Summer Splash due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Summer Splash, UPC/PLU 25102000000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0684-2015·2014-12-17

    Whole Foods Market Recalls Peach Basil Glazed Smoked Salmon

    Whole Foods Market is recalling Peach Basil Glazed Smoked Salmon due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Peach Basil Glazed Smoked Salmon, UPC/PLU 29074000000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0638-2015·2014-12-17

    Whole Foods Market Sweet Petites Recalled for Listeria Risk

    Whole Foods Market is recalling Sweet Petites 2 For $3 due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Sweet Petites 2 For $3, UPC/PLU 21687700000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0695-2015·2014-12-17

    Whole Foods Market Fruit Kabobs Recalled for Listeria Risk

    Whole Foods Market is recalling Fruit Kabobs for Grilling due to potential Listeria monocytogenes contamination. The product was sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Fruit Kabobs for Grilling, UPC/PLU 29656500000
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0539-2015·2014-12-17

    Instrumed Recalls Manual Trephines for Regulatory Compliance

    Instrumed International is withdrawing 74 manual trephines from the market because the devices do not meet FDA requirements for pre-amendment marketing.

    Product
    Manual trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, Boss Instruments, and Surgical Direct brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0581-2015·2014-12-17

    Conformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers

    ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.

    Product
    Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0517-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0522-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0570-2015·2014-12-17

    Stryker 1488 HD 3-Chip Inline Camera Recalled for Colored Screen Image

    Stryker Endoscopy is recalling 1,965 HD 3-Chip Inline Cameras because a colored screen image may occur in certain operating room environments.

    Product
    1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0525-2015·2014-12-17

    Concentric Medical Recalls Distal Access Catheters Due to Incorrect Labeling

    Concentric Medical is recalling 87 Distal Access Catheters because they were shipped with Directions for Use containing instructions for aspiration, which are only approved outside the US.

    Product
    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peri
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0513-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0615-2015·2014-12-17

    Essentia Water Recalled for Potential Mold Contamination

    Nature's Way Purewater Systems is recalling Essentia Hydration Perfected Purified Water and Electrolytes because the product may contain mold.

    Product
    ESSENTIA Hydration Perfected Purified Water and Electrolytes, 9.5 pH, Manufactured for Essentia Water Inc., 22833 Bothell Evrt Hwy, Bothell WA 98021 Packaging: For 33.8 fl oz (1.0 liter) plastic bottles: Wholesale: flats with 2- 6 packs per flat; 12 - bottle box. Retail sal
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0573-2015·2014-12-17

    Arrow Recalls Nerve Block Components Due to Labeling Inconsistency

    Arrow International Inc is recalling specific lots of Continuous Nerve Block Components because the packaging incorrectly identifies the needle gauge. No injuries or illnesses have been reported.

    Product
    Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2015·2014-12-17

    Stryker Recalls 1488 HD 3-Chip Cameras Due to Colored Screen Image

    Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.

    Product
    1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0519-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0510-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0292-2015·2014-12-17

    Pfizer Recalls Tikosyn Capsules Due to Potential Cracks or Breakage

    Pfizer is recalling Tikosyn (dofetilide) capsules because they may be cracked or broken. The recall affects 31,569 bottles shipped to 4,447 direct accounts.

    Product
    TIKOSYN — TIKOSYN (DOFETILIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0512-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 total temporomandibular joint replacement systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0529-2015·2014-12-17

    Cooper Vision Recalls Soft Contact Lenses Due to Incorrect Lens Axis

    Cooper Vision Caribbean Corp. is recalling 1,170 soft contact lenses because portions of the lots may contain units with an incorrect lens axis condition.

    Product
    Soft Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0516-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement System

    Biomet Microfixation is recalling 42 units of the Total Temporomandibular Joint Replacement System because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0180-2015·2014-12-17

    Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure

    Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.

    Product
    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0705-2015·2014-12-17

    Orrington Farms Chicken Broth Base Recalled for Mislabeling

    Kent Precision Foods Group is recalling Orrington Farms Chicken Flavored Broth Base due to incorrect labeling on beef-flavored product.

    Product
    Chicken flavored broth base and seasoning, low sodium sold under the Orrington Farms brand in 5 oz. plastic jars.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0574-2015·2014-12-17

    Zimmer Title 2 Bone Screw Remover Recalled for Weld Failure Risk

    Zimmer, Inc. is recalling 14 Title 2 Bone Screw Remover instruments due to a risk that the weld may break during use, potentially delaying surgery.

    Product
    Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2015·2014-12-17

    Concentric Medical Recalls Trevo Pro 4 Stent Retrievers Due to Labeling Error

    Concentric Medical is recalling 10 units of Trevo Pro 4 Stent Retrievers because they were shipped with non-U.S. instructions for use that did not align with U.S. indications.

    Product
    Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0569-2015·2014-12-17

    Stryker 1488 HD 3-Chip Camera Recall for Colored Screen Image

    Stryker Endoscopy is recalling 1,965 1488 HD 3-Chip Cameras because a colored screen image may occur in certain operating room environments.

    Product
    1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasophary
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0290-2015·2014-12-17

    Fresenius Kabi Recalls Gentamicin Vials Due to Missing Stoppers

    Fresenius Kabi is recalling 92,125 vials of Gentamicin Injection because some may be missing stoppers. The product was distributed nationwide and in Puerto Rico.

    Product
    GENTAMICIN — GENTAMICIN (GENTAMICIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0532-2015·2014-12-17

    Instrumed Recalls Uterine Tenaculum Hooks for Regulatory Compliance

    Instrumed International is withdrawing 26 uterine tenaculum hooks because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0203-2015·2014-12-17

    Philips Recalls BrightView XCT Gamma Cameras Due to CT Scan Interruptions

    Philips Medical Systems is recalling BrightView XCT gamma cameras because the CT portion of scans may be interrupted and fail to complete successfully.

    Product
    BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0536-2015·2014-12-17

    Instrumed Recalls External Vein Strippers Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 479 external vein strippers because the company did not market them before 1976, failing to meet FDA pre-amendment requirements.

    Product
    An external vein stripper is an extravascular device used to remove a section of a vein sold under the Symmetry Surgical, CareFusion, Boss Instruments, Phoenix Instruments, Autobahn Surgical, Echo Instruments, Millennium Surgical, B.B.M. Surgical Instruments, Stealth Surgical, Me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0701-2015·2014-12-17

    Bar Guo Preserved Plum Candy Recalled for Non-Permitted Cyclamates

    Tristar Food Wholesale is recalling Bar Guo Preserved Plum Candy containing non-permitted cyclamates, undeclared benzoic acid, and undeclared Yellow #5.

    Product
    Bar Guo Food Preserved Plum Candy, Net Wt. 8 oz. (228g), Packaged in a Cellophane Bag, Product of China: Tristar Food Wholesale Inc., NJ
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0514-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than previously validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0543-2015·2014-12-17

    Instrumed Recalls Cushing Burr Instruments for Regulatory Non-Compliance

    Instrumed International is withdrawing Cushing burrs because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0511-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0521-2015·2014-12-17

    Biomet Microfixation Recalls Total Temporomandibular Joint Replacement Systems

    Biomet Microfixation is recalling 42 units of Total Temporomandibular Joint Replacement Systems because laser etching on the parts is wider and deeper than validated conditions.

    Product
    Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0298-2015·2014-12-17

    CareFusion Recalls Chlorhexidine Gluconate Surgical Hand Scrub for Concentration Issues

    CareFusion 213, LLC is recalling Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, because it contains higher concentrations of available chlorhexidine gluconate than required.

    Product
    Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0555-2015·2014-12-17

    Gardner-Wells wrenches withdrawn for pre-amendment regulatory non-compliance

    Instrumed International is withdrawing Gardner-Wells wrenches because they were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.

    Product
    Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2015·2014-12-17

    Instrumed Recalls D'errico Perforator Drills Due to Regulatory Non-Compliance

    Instrumed International is withdrawing D'errico perforator drills because they do not meet FDA requirements for pre-amendment devices.

    Product
    D'errico perforator drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Teleflex Medical, and CareFusion brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0537-2015·2014-12-17

    Instrumed Recalls Manual Bunnell Cranial Drills for Regulatory Non-Compliance

    Instrumed International is withdrawing 13 manual Bunnell cranial drills because the company did not market them before 1976, failing FDA pre-amendment requirements.

    Product
    Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0549-2015·2014-12-17

    Instrumed Recalls Galt Trephines for Regulatory Compliance Issues

    Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0548-2015·2014-12-17

    Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance

    Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0557-2015·2014-12-17

    Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance

    Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0556-2015·2014-12-17

    Instrumed Recalls CVB Distraction Screws Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 790 CVB distraction screws because the devices were not marketed before 1976, failing FDA pre-amendment requirements.

    Product
    CVB distraction screws are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Millennium Surgical, Medfix International, CareFusion, Boss Instruments, Medline Industries, Surgical Direct, and Telef
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0553-2015·2014-12-17

    Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues

    Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.

    Product
    Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand name
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0545-2015·2014-12-17

    Instrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance

    Instrumed International is withdrawing McKenzie Perforator Drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0552-2015·2014-12-17

    Instrumed Recalls Lock Nuts for Titanium Traction Tongs

    Instrumed International is withdrawing 49 lock nuts for titanium traction tongs because the devices were not marketed prior to September 26, 1976, and do not meet FDA pre-amendment requirements.

    Product
    Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Millennium Surgical, Boss Instruments, and Stealth Surgical brand names
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0558-2015·2014-12-17

    Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance

    Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.

    Product
    Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0533-2015·2014-12-17

    Instrumed Recalls Endometrial Suction Curettes Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 26 endometrial suction curettes because the devices were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.

    Product
    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include cathet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0550-2015·2014-12-17

    Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance

    Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0540-2015·2014-12-17

    Instrumed Recalls Hudson Braces for Regulatory Compliance Issues

    Instrumed International is withdrawing Hudson braces from the market because the devices do not meet FDA requirements for pre-amendment status.

    Product
    Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0538-2015·2014-12-17

    Instrumed Recalls Mogen Circumcision Clamps for Regulatory Non-Compliance

    Instrumed International is withdrawing 421 Mogen circumcision clamps because the company did not market these devices prior to September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0559-2015·2014-12-17

    Instrumed Recalls Schoitz Weights for Regulatory Compliance Issues

    Instrumed International is withdrawing Schoitz weights from the market because the devices do not meet FDA requirements for pre-amendment marketing.

    Product
    Schoitz weights are manual devices used with Schoitz tonometers and are intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0547-2015·2014-12-17

    Instrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance

    Instrumed International is withdrawing McKenzie enlarging burrs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.

    Product
    McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0541-2015·2014-12-17

    Hudson cerebellar extensions recalled for pre-amendment marketing status issues

    Instrumed International is withdrawing Hudson cerebellar extensions because they were not marketed before September 26, 1976, and do not meet FDA pre-amendment requirements.

    Product
    Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0554-2015·2014-12-17

    Instrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance

    Instrumed International is withdrawing 17 traction tong replacement screws because they do not meet FDA requirements for pre-amendment devices.

    Product
    Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the CareFusion, Boss Instruments, and Stealth Surgical brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0291-2015·2014-12-17

    Sandoz Recalls Fluoxetine Capsules Due to Illegible Logo

    Sandoz Inc. is recalling one lot of Fluoxetine Capsules because the logo on the capsules is illegible.

    Product
    Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0534-2015·2014-12-17

    Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0535-2015·2014-12-17

    Instrumed Recalls Surgical Trocars Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 11 surgical trocars because they do not meet FDA requirements for pre-amendment devices.

    Product
    A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula sold under the Symmetry Surgical, CareFusion, and Ambler Surgical brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0542-2015·2014-12-17

    Instrumed Recalls Cushing Perforating Drills for Regulatory Non-Compliance

    Instrumed International is withdrawing nine Cushing perforating drills because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0551-2015·2014-12-17

    Instrumed Recalls Non-Springloaded Traction Tongs for Regulatory Compliance

    Instrumed International is withdrawing 67 replacement screw non-springloaded traction tongs because the company did not market them prior to 1976, failing to meet FDA pre-amendment requirements.

    Product
    Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the CareFusion, Boss Instruments, Millennium Surgical, Prezio Health, and Stealth Surgical bran
    Category
    Medical Device
    Distribution
    Distributed nationwide

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