The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
319
High
264
Moderate
310
Low
63

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 31% are Severe.

501–600 of 1028

  • 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-0648-2015·2014-12-17

    Whole Foods Market Peaches Cream Cake Recalled for Listeria Risk

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

    Product
    Whole Foods Market Cake-Peaches Cream 9", UPC/PLU 20179200000; Whole Foods Market Cake-Peaches Cream 6", UPC/PLU 20931300000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0649-2015·2014-12-17

    Whole Foods Market Peaches and Cream Pies Recalled for Listeria Risk

    Whole Foods Market is recalling Peaches and Cream Pies due to potential Listeria monocytogenes contamination. Consumers should check their stores for affected products.

    Product
    Whole Foods Market Pie-Peaches and Cream 8in, UPC/PLU 20139000000;Whole Foods Market Pie-Peaches and Cream 4in, UPC/PLU 20628800000; Whole Foods Market WFM Pie-Peaches and Cream Mini, UPC/PLU 20656900000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0625-2015·2014-12-17

    Cheesecake Royale Recalls Turtle Fudge Brownies Due to Undeclared Wheat

    Cheesecake Royale, Inc. is recalling 31 units of Turtle Fudge Brownies because they contain undeclared wheat. The product was distributed in Florida, Arkansas, and Texas.

    Product
    Turtle Fudge Brownies, Net Wt. (5 lbs), Item # 042, UPC#85538300042
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0530-2015·2014-12-17

    Abbott Healon EndoCoat Ophthalmic Device Recalled for Finger Grip Defect

    Abbott Medical Optics is recalling Healon EndoCoat ophthalmic devices because the finger grip can dislodge, potentially causing eye trauma during surgery.

    Product
    Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0672-2015·2014-12-17

    Whole Foods Market Recalls Heirloom Tomato Peach and Mozzarella Salad

    Whole Foods Market is recalling Heirloom Tomato Peach and Mozzarella Salad due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Heirloom Tomato Peach and Mozzarella Salad, UPC/PLU 20253800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0685-2015·2014-12-17

    Whole Foods Market Recalls Peach Basil Stuffed Blackened Salmon

    Whole Foods Market is recalling Peach Basil Stuffed Blackened 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 Blackened Salmon, UPC/PLU 29512800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0565-2015·2014-12-17

    Pfm Medical Recalls ASEPT Peritoneal Drainage Systems for Bacterial Endotoxin

    Pfm Medical is recalling 83 units of the ASEPT Peritoneal Drainage System because the devices may exceed USP limits for bacterial endotoxin.

    Product
    ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0633-2015·2014-12-17

    Whole Foods Market Recalls Mango Peach Salsa Due to Listeria Risk

    Whole Foods Market is recalling Mango Peach Salsa products due to potential contamination with Listeria monocytogenes.

    Product
    Whole Foods Market Mango Peach Salsa MIN, UPC/PLU 50195 Whole Foods Market Mango Peach Salsa XS, UPC/PLU 58122
    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-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-0661-2015·2014-12-17

    Whole Foods Market Recalls Balsamic Chicken Breast and Peaches

    Whole Foods Market is recalling Balsamic Chicken Breast & Peaches due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Balsamic Chicken Breast & Peaches, UPC/PLU 20254100000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0527-2015·2014-12-17

    Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization

    Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.

    Product
    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0658-2015·2014-12-17

    Whole Foods Market Recalls Smoothie-Immunity Boost Due to Listeria Risk

    Whole Foods Market is recalling Smoothie-Immunity Boost products in 16, 24, and 32 oz. sizes due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Smoothie-Immunity Boost 16 oz., UPC/PLU 50172; Whole Foods Market Smoothie-Immunity Boost 24 oz., UPC/PLU 50173; Whole Foods Market Smoothie-Immunity Boost 32 oz., UPC/PLU 50174
    Category
    Food
    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 (Food)·F-0640-2015·2014-12-17

    Whole Foods Market Peach Pies Recalled for Listeria Risk

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

    Product
    Whole Foods Market Pie Large Peach, UPC/PLU 21759600000; Whole Foods Market Pie Small 6" Peach, UPC/PLU 24032900000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0659-2015·2014-12-17

    Whole Foods Market Apple Pie Smoothies Recalled for Listeria Risk

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

    Product
    Whole Foods Market Smoothie-Apple Pie 16 oz (HSH), UPC/PLU 25113; Whole Foods Market Smoothie-Apple Pie 24 oz (HSH), UPC/PLU 2007
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0700-2015·2014-12-17

    Whole Foods Market Recalls Fresh Peachy Keen Juice for Listeria Risk

    Whole Foods Market is recalling Fresh Peachy Keen Juice 16 oz. bottles due to potential contamination with Listeria monocytogenes.

    Product
    Whole Foods Market Fresh Peachy Keen Juice 16 oz., UPC/PLU 29683800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0652-2015·2014-12-17

    Whole Foods Market Peach Parfaits Recalled for Listeria Risk

    Whole Foods Market is recalling two varieties of peach parfaits due to the potential for Listeria monocytogenes contamination.

    Product
    Whole Foods Market WF Bakery Parfait-Peach, UPC/PLU 20683800000; Whole Foods Market Peach Parfait, UPC/PLU 20690500000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0681-2015·2014-12-17

    Whole Foods Market Pear Crisp Slaw Recalled for Listeria Risk

    Whole Foods Market is recalling Pear Crisp Slaw due to potential Listeria monocytogenes contamination. Consumers should discard the product.

    Product
    Whole Foods Market CC HSH Pear Crisp Slaw, UPC/PLU 25730500000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0689-2015·2014-12-17

    Whole Foods Market Recalls Orchard Peach Freeze for Listeria Risk

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

    Product
    Whole Foods Market Tea Hive-Orchard Peach Freeze, UPC/PLU 30868
    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-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 (Food)·F-0660-2015·2014-12-17

    Whole Foods Market Recalls Peach Pizazz Smoothies Due to Listeria Risk

    Whole Foods Market is recalling Peach Pizazz smoothies in 16, 24, and 32-ounce sizes because they may be contaminated with Listeria monocytogenes.

    Product
    Whole Foods Market Smoothie-Peach Pizazz 24 oz., UPC/PLU 50279; Whole Foods Market Smoothie-Peach Pizazz 16 oz., UPC/PLU 50278; Whole Foods Market Smoothie-Peach Pizazz 32 oz., UPC/PLU 50280
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0671-2015·2014-12-17

    Whole Foods Market Recalls Heirloom Tomato and Nectarine Salad

    Whole Foods Market is recalling Heirloom Tomato and Nectarine Salad due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market Heirloom Tomato and Nectarine Salad, UPC/PLU 20253800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0634-2015·2014-12-17

    Whole Foods Market Chantilly Seasonal Cake Recalled for Listeria Risk

    Whole Foods Market is recalling specific Chantilly Seasonal cakes due to potential Listeria monocytogenes contamination. The products were sold in most states except Florida, Washington, and Oregon.

    Product
    Whole Foods Market Cake Slice Chantilly Seasonal, UPC/PLU 21615600000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 24420800000; Whole Foods Market Cake Single Layer Chantilly Seasonal, UPC/PLU 28825800000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0515-2015·2014-12-17

    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 Narrow Ti Mand Reconstruction of the temporomandibular joint
    Category
    Medical Device
    Distribution
    3 states
  • 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-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-0699-2015·2014-12-17

    Whole Foods Market Fresh Fruit Tarts Recalled for Listeria Risk

    Whole Foods Market is recalling fresh fruit tarts decorated with plums due to potential Listeria monocytogenes contamination.

    Product
    Whole Foods Market 4" fresh fruit tart decorated with plums, UPC/PLU 0201189005002; Whole Foods Market 6" fresh fruit tart decorated with plums, UPC/PLU 0201898022000; Whole Foods Market 9" fresh fruit tart decorated with plums, UPC/PLU 0201897029000
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0622-2015·2014-12-17

    Cheesecake Royale Recalls Lemoncello Mascarpone Cakes Due to Undeclared Allergens

    Cheesecake Royale is recalling 70 Lemoncello Mascarpone Cakes because they contain undeclared FD&C Yellow #5 and wheat.

    Product
    Lemoncello Mascarpone Cake, 14 Slices, KEEP FROZEN, NET Wt. 6.25 lbs (2.8kg), UPC#85538300088, Manufactured by: Cheesecake Royale, Inc. Dallas, TX 75218, www.CheesecakeRoyale.com
    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-0624-2015·2014-12-17

    Cheesecake Royale Recalls Rocky Road Brownies for Undeclared Wheat

    Cheesecake Royale, Inc. is recalling Rocky Road Brownies because the product contains undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    Rocky Road Brownies, Net Wt. (5 lbs), Item # 041, UPC#85538300041
    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 (Devices)·Z-0579-2015·2014-12-17

    ArthroCare Medical Recalls Ambient HipVac and KVac Wands for Sterile Barrier Breach

    ArthroCare Medical Corporation is recalling 23,119 Ambient HipVac and KVac wands due to a potential breach of the sterile barrier caused by defective product trays.

    Product
    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0693-2015·2014-12-17

    Whole Foods Market Parfait Recalled for Potential Listeria Contamination

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

    Product
    Whole Foods Market Parfait, UPC/PLU 20642800000
    Category
    Food
    Distribution
    3 states
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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…
    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-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-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 (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…
    Category
    Medical Device
    Distribution
    17 states
  • 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-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-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-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-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 (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…
    Category
    Food
    Distribution
    17 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-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-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-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 (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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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 (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-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 (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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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-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…
    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-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…
    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-0544-2015·2014-12-17

    Instrumed Recalls Hudson Burrs for Pre-Amendment Regulatory Non-Compliance

    Instrumed International is withdrawing 16 Hudson burrs from the market because the company did not market these devices prior to September 26, 1976, and therefore does not meet FDA requirements for Pre-Amendment devices.

    Product
    Hudson burrs 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, CareFusion, Boss Instruments, and Medline Industries brand names.
    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-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…
    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…
    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…
    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-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-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 (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-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)…
    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…
    Category
    Medical Device
    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-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 (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…
    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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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

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