The Recall Desk

Archive

January 2015 recalls

327 recalls were announced in January 2015.

What the numbers show

Critical
23
Severe
124
High
114
Moderate
53
Low
13

Of the 327 recalls this month scored against our rubric, 7% are Critical, 38% are Severe.

201–300 of 327

  • SevereUSDA FSIS·014-2015(Original)·2015-01-17

    La Guadalupana Recalls Chicken Tamales Lacking Required Safety Plans

    La Guadalupana Wholesale is recalling 8,856 pounds of chicken tamales because they were produced without a required HACCP plan or Listeria program.

    Product
    La Guadalupana — Illinois Firm Recalls Chicken Products Produced Without Adequate Ready-To-Eat HACCP Plan and a Listeria Monocytogenes Program
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·015-2015·2015-01-17

    Kalle USA Recalls Pork Products Produced Without Inspection

    Kalle USA is recalling approximately 168,473 pounds of dehydrated pork products that were not presented for U.S. inspection. No adverse reactions have been reported.

    Product
    Illinois Firm Recalls Pork Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·012-2015·2015-01-16

    Kabobs Recalls Beef and Chicken Products Due to Undeclared Peanuts

    Kabobs Acquisition Inc. is recalling approximately 869 pounds of beef and chicken products because they may contain undeclared peanuts.

    Product
    Kabobs Aquisition, LLC — Georgia Firm Recalls Beef and Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • CriticalUSDA FSIS·011-2015·2015-01-16

    Buffalo Provisions Recalls Chorizo Products Due to Undeclared Peanut Allergen

    Buffalo Provisions is recalling approximately 48,210 pounds of chorizo products because they may contain undeclared peanuts. The products were distributed in Connecticut, New Jersey, and New York.

    Product
    New York Firm Recalls Chorizo Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereUSDA FSIS·010-2015·2015-01-16

    Heywoods Tasso Pork Shoulder Recalled for Undeclared Peanuts

    Heywoods Meat Haus & Provision Co. is recalling 931 pounds of Tasso pork shoulder products due to misbranding and undeclared peanut allergens.

    Product
    The Heywoods Group Corp — Georgia Firm Recalls Pork Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0768-2015·2015-01-14

    Gold Star Recalls Cold Smoked Steelhead Due to Listeria Contamination

    Gold Star Smoked Fish Corp. is recalling cold smoked steelhead due to Listeria monocytogenes contamination. The product was distributed in New York, New Jersey, and Florida.

    Product
    GOLD STAR'S FINEST COLD SMOKED STEELHEAD, Net Wt. (To Be Weighed At Time of Sale). UPC 021 143140026. Product is sold in a Vacuum Pack with blue and gold label. PERISHABLE. KEEP REFRIGERATED. Distributed by: Gold Star 570 Smith Street Brooklyn, NY 11231, 718-522-1545.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0908-2015·2015-01-14

    DePuy I.M. Hole Locator Instrument Recalled for Fracture Risk

    DePuy Orthopaedics is recalling 1,130 I.M. Hole Locator Instruments because excessive force during use may lead to intra-operative femoral fracture.

    Product
    I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2015·2015-01-14

    Synthes Small Electric Drive Recalled for Unintended Start and Malfunction

    Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.

    Product
    Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0921-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER U Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER U remote controls because damaged units may cause unintended movement of operating tables during surgery.

    Product
    IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sys
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0905-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Femoral Impactor ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its rele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·009-2015·2015-01-14

    Agri Star Recalls Beef Franks for Undeclared Peanuts and Misbranding

    Agri Star Meat & Poultry is recalling 1,690 pounds of beef franks that may contain undeclared peanuts and are misbranded as gluten-free.

    Product
    Agri Star Meat and Poultry, LLC — Iowa Firm Recalls Beef Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0767-2015·2015-01-14

    Azure Farm Organic Cilantro Flakes Recalled for Salmonella Risk

    K F K Seasonings LLC is recalling Azure Farm Organic Cilantro Flakes due to potential Salmonella contamination. The product was distributed in Oregon.

    Product
    Cilantro Flakes Organic, sold under private label Azure Farm, Net wt. 4 oz. or 1 lb. Product is packed in the heat seal poly bag. The 4 oz. bag has UPC 8 70722 00256 5. The 1 lb. bag has UPC 8 70722 00255 8. The 4 oz bag is labeled in parts: "***Cilantro Flakes Organic***G
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0924-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables because complaints were reported of unintended movement during surgical cases.

    Product
    (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sys
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-0903-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled for Fracture Risk During Surgery

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they have broken and produced small pieces that could be left in patients during knee replacement surgery.

    Product
    Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home its r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0764-2015·2015-01-14

    Abdallah Caramel Bites Recalled for Peanut Contamination

    Abdallah Candies is recalling Holiday Caramel Bites because a customer found a peanut butter bite in the package.

    Product
    Abdallah Milk Chocolate Bites CARAMEL, Net Wt 4.5 oz. (127g), UPC 7 6668407116 2, Ingredients: Pure milk chocolate (sugar, chocolate liquor, cocoa butter, whole milk, soy lecithin (an emulsifier), vanilla), corn syrup, sweetened condensed milk, cream, sugar, palm oil, salt, guar
    Category
    Food
    Distribution
    35 states
  • SevereNHTSA·15V010000·2015-01-14

    Winnebago Recalls 2013-2015 Travel Trailers Due to Propane Leak Risk

    Winnebago is recalling specific 2013-2015 Minnie and Sunnybrook Remington travel trailers because the axle may crack the propane pipe fitting, creating a fire hazard.

    Product
    WINNEBAGO — WINNEBAGO, SUNNYBROOK MINNIE, REMINGTON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V012000·2015-01-14

    Nissan and Infiniti Recall Vehicles for Brake Caliper Fastener Issue

    Nissan is recalling 2014-2015 Pathfinder, Rogue, and Infiniti QX60 vehicles because front wheel hub fasteners may be under-torqued, risking brake separation.

    Product
    INFINITI — INFINITI, NISSAN QX60, PATHFINDER, ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0334-2015·2015-01-14

    Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Hospira Inc. is recalling 30,840 bags of 0.9% Sodium Chloride Injection, USP, 100mL, due to a potential leak at the administrative port that compromises sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0904-2015·2015-01-14

    DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk

    DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.

    Product
    Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0923-2015·2015-01-14

    Trumpf Medical Systems Recalls IIR Remote Controls for Operating Tables

    Trumpf Medical Systems is recalling IIR remote controls for JUPITER operating tables due to reports of unintended movement during surgery.

    Product
    IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer syste
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0922-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls Due to Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls for operating tables because damaged units may cause unintended movement during surgery.

    Product
    IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transf
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0880-2015·2015-01-14

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Test Strips because the system may provide INR results significantly lower than reference laboratory methods.

    Product
    Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139 Alere INRatio PT/INR Test Strips, Box of 48 The test strips are packaged in individually pouched test strips in a labeled box with 12 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2015·2015-01-14

    Siemens Symbia S Series Medical Imaging Systems Recalled for Detector Motion

    Siemens is recalling 877 Symbia S series imaging systems due to reports of unintended detector motion that may cause patient compression injuries.

    Product
    The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0913-2015·2015-01-14

    Siemens Symbia Intevo SPECT CT Systems Recalled for Detector Motion

    Siemens is recalling six Symbia Intevo SPECT CT systems worldwide because unintended detector motion may cause patient compression injuries.

    Product
    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0914-2015·2015-01-14

    Siemens e.cam Systems Recalled for Potential Patient Finger Injury

    Siemens Medical Solutions is recalling 4,462 e.cam emission computed tomography systems due to a potential risk of patient finger injury.

    Product
    e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Operating Table Remote Controls

    Trumpf Medical Systems is recalling JUPITER operating table remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0909-2015·2015-01-14

    Ebi Recalls Cypher MIS Screw System Due to Inoperative Screw Heads

    Ebi, LLC is recalling the Cypher MIS Screw System because screw heads may splay or fracture, rendering the device inoperative.

    Product
    Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and sta
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0945-2015·2015-01-14

    Centurion Pacemaker Tray Recalled Due to Human Hair Contamination

    Centurion Medical Products is recalling 8 pacemaker trays because a customer reported human hair embedded in the stopper of a single unit.

    Product
    Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Operating Table Remote Controls

    Trumpf Medical Systems is recalling JUPITER operating table remote controls because damaged units may cause unintended movement during surgery.

    Product
    IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to t
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0929-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls due to reports of unintended movement during surgical cases caused by damaged units.

    Product
    IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sy
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0912-2015·2015-01-14

    Siemens Symbia T Series SPECT/CT Systems Recalled for Detector Motion

    Siemens Medical Solutions USA is recalling 1,330 Symbia T series SPECT/CT systems worldwide due to reports of unintended radial detector motion that may cause patient compression injuries.

    Product
    The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0940-2015·2015-01-14

    Intuitive Surgical Recalls da Vinci Si Vision Side Carts Due to Wheel Loosening

    Intuitive Surgical is voluntarily correcting 202 da Vinci Si Vision Side Carts where caster wheel bolts may unthread, causing wheels to loosen.

    Product
    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2015·2015-01-14

    Vision RT AlignRT 3D Imaging System Recalled for Potential Use Error

    Vision RT Inc. is recalling 55 AlignRT 3D surface imaging systems due to a potential use error when the external Gate Controller is turned on after software startup.

    Product
    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2015·2015-01-14

    KCI CelluTome Epidermal Harvesting System Harvester Blades May Drift During Shipping

    KCI USA is recalling CelluTome Epidermal Harvesting System Harvesters because blades may drift and protrude from the top plate during shipping.

    Product
    CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER U Cable Remote Controls

    Trumpf Medical Systems is recalling 137 JUPITER U cable remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer s
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0919-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Operating Table Remote Controls

    Trumpf Medical Systems is recalling JUPITER operating table remote controls because damaged units may cause unintended movement during surgery.

    Product
    Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient tra
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0926-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Operating Table Remote Controls

    Trumpf Medical Systems is recalling JUPITER operating table remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Food)·F-0763-2015·2015-01-14

    Citizen Chef Organic Superfood Salad Recalled for Undeclared Milk

    Taylor Farms Pacific is recalling Citizen Chef Organic Superfood Salad due to undeclared milk on individual units. The outer packaging is labeled correctly.

    Product
    Citizen Chef Organic Superfood Salad- 4 Organic Salads. Power Greens, Walnuts, Feta, Dried Cranberries and Blueberries with Pomegranate Vinaigrette. Net Wt. 4.5 oz. (142g) USDA Organic UPC 30233 20009 Taylor Farms Pacific Stockton, CA. 95376
    Category
    Food
    Distribution
    1 state
  • HighCPSC·15060·2015-01-14

    NPD Furniture Recalls Abby Dining Chairs Due to Fall Hazard

    NPD Furniture is recalling about 250 Abby Dining Chairs because the legs can break unexpectedly, posing a fall hazard. No injuries have been reported.

    Product
    Abby Dining Chair
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Cable Remote Controls

    Trumpf Medical Systems is recalling JUPITER cable remote controls due to reports of unintended movement during surgical cases.

    Product
    Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer sy
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0925-2015·2015-01-14

    Trumpf Medical Systems Recalls JUPITER Remote Controls for Unintended Movement

    Trumpf Medical Systems is recalling JUPITER remote controls used with operating tables due to reports of unintended movement during surgical cases.

    Product
    (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-0902-2015·2015-01-14

    Horiba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues

    Horiba Medical is recalling ABX PENTRA Reagent Containers because they may not sit properly in the rack, potentially causing incorrect test results without an alarm.

    Product
    ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0942-2015·2015-01-14

    Centurion Chest Tube Tray Recalled Due to Human Hair Contamination

    Centurion Medical Products is recalling 42 Chest Tube Tray kits because a single unit was found to contain human hair embedded in the stopper.

    Product
    Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0944-2015·2015-01-14

    Centurion Diagnostic Imaging Tray Recalled for Human Hair Particulate

    Centurion Medical Products is recalling 760 Diagnostic Imaging Trays due to a confirmed report of human hair embedded in a stopper.

    Product
    Diagnostic Imaging Tray (General Surgery convenience kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2015·2015-01-14

    Alere INRatio Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio PT/INR Monitor systems because they may provide INR results significantly lower than reference laboratory methods.

    Product
    INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Alere INRatio Replacement Monitor The test systems contain individually packaged components needed to use the product, such as a monitor,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0937-2015·2015-01-14

    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Recall

    Stryker Orthobiologics is recalling Imbibe Aliquot Needle Bone Cement Needles due to potential breaches in the inner or outer packaging pouches.

    Product
    Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0332-2015·2015-01-14

    Par Pharmaceutical Recalls HydrALAZINE Tablets Due to Aluminum Particles

    Par Pharmaceutical is recalling one lot of HydrALAZINE Hydrochloride tablets because small aluminum particles were found in the product.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 25 mg, 100 count bottle Rx only, Distributed by: Par Pharmaceutical Companies, Inc. Spring Valley, NY10977
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2015·2015-01-14

    CSA Medical truFreeze System Recalled for Timer Sound Loss

    CSA Medical is recalling 46 truFreeze cryogenic surgical devices because the timer may lose its audible sound, potentially affecting surgical procedures.

    Product
    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of t
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-0943-2015·2015-01-14

    Centurion Nerve Block Tray Recalled for Human Hair Contamination

    Centurion Medical Products is recalling 480 Nerve Block Trays due to a confirmed report of human hair embedded in a stopper.

    Product
    Nerve Block Tray (Nerve Block convenience kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0765-2015·2015-01-14

    Vintage Pure Bee Flower Honey Recalled for Sulfamethazine Levels

    Vintage Food Corp. is recalling 233 cases of Vintage Pure Bee Flower Honey because the product contains higher than recommended levels of sulfamethazine.

    Product
    Vintage Pure Bee Flower Honey, Net Weight 16.4 oz (465g), Packaged in a Glass Jar, Product of Turkey, Imported by: Vintage Food Corp., 849 Newark Tpke, Kearny, NJ 07032, USA, UPC 603608629903
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0910-2015·2015-01-14

    McKesson Cardiology ECG Management Software Recalled for Incorrect Time Stamps

    McKesson Israel Ltd. is recalling McKesson Cardiology ECG Management software versions 13.1 and 13.1.1 because a software error causes incorrect ECG procedure time stamps.

    Product
    McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0336-2015·2015-01-14

    Actavis Recalls Gabapentin Capsules Due to Physical Defects

    Actavis Elizabeth LLC is recalling specific lots of Gabapentin 400 mg capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0335-2015·2015-01-14

    Right Value Recalls Glutathione Injectable Due to Incorrect Gas Formulation

    Right Value Drug Stores is recalling specific lots of Glutathione 200 mg/mL Injectable because an incorrect gas was used to remove oxygen from the vials.

    Product
    Glutathione 200 mg/mL Injectable, packaged in a) 5 mL MDV (multiple dose vials), b) 30 mL MDV (multiple dose vials), and c) 100 mL MDV (multiple dose vials), Rx only, Carie Boyd's Prescription Shop, 122 Grapevine Highway, Hurst, TX 76054, (817) 282-9376.
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0939-2015·2015-01-14

    Baxter HomeChoice Automated Peritoneal Dialysis Systems Recalled for Updated Warnings

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis systems because the patient guide lacks updated warnings and cautions.

    Product
    HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2015·2015-01-14

    Baxter Amia Automated PD Systems Recalled for Battery Charging Error

    Baxter Healthcare is recalling 55 Amia Automated PD systems due to a battery charging error that prevents the device from functioning.

    Product
    Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0946-2015·2015-01-14

    Siemens Recalls Dimension Vista Myoglobin Calibrator Due to Positive Result Shift

    Siemens Healthcare Diagnostics is recalling Dimension Vista Myoglobin Calibrators because they may cause test results to shift up to 12% higher than expected.

    Product
    Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO) method on the Dimension Vista System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0338-2015·2015-01-14

    Actavis Recalls Gabapentin Capsules Due to Physical Defects

    Actavis Elizabeth LLC is recalling 29,622 bottles of Gabapentin capsules distributed in Puerto Rico due to clumping, breaking, and packaging defects.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0331-2015·2015-01-14

    Qualitest Recalls Acetaminophen and Codeine Oral Solution Due to Impurity

    Qualitest Pharmaceuticals is recalling specific lots of Acetaminophen and Codeine Phosphate Oral Solution because they failed impurity specifications for p-Aminophenol.

    Product
    ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC 0603-9013-58, UPC 3 0603-9013-58 6, Rx only, Manufactured for: QUALITEST PHARMACEUTICA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2015·2015-01-14

    Steris Recalls Harmony vLED Surgical Lighting Systems Due to Inconsistent Illumination

    Steris is recalling 140 Harmony vLED Surgical Lighting Systems because LED modules may illuminate inconsistently. The units were distributed worldwide.

    Product
    Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visible illumination of the surgical field or the patient for the operating room s
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-0907-2015·2015-01-14

    Spinal Elements Recalls Ti-Bond Marketing Literature Due to Misleading Claims

    Spinal Elements is recalling Ti-Bond marketing literature because the content regarding the Ti-Bond coating is unsubstantiated and misleading for spine applications.

    Product
    Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0906-2015·2015-01-14

    Exactech Recalls Mislabeled Optetrak Femoral Implants

    Exactech, Inc. is voluntarily recalling 96 Optetrak femoral implants due to mislabeling. The devices were distributed internationally to 13 countries.

    Product
    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0938-2015·2015-01-14

    Stryker Orthobiologics Recalls Imbibe Bone Marrow Aspiration Needles

    Stryker Orthobiologics is recalling Imbibe Bone Marrow Aspiration Needles due to a potential breach in the inner or outer packaging pouches.

    Product
    Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Needle (bullet-tip), 11 gauge x 6 inch 2090-0029 Needle (bullet-tip), 8 gauge x 6 inch 2090-0047 Needle (bullet-tip), 8 gauge x 8 inch 2090-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0333-2015·2015-01-14

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Specification Failure

    Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% because a known impurity exceeded specifications at the 12-month stability point.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·008-2015·2015-01-14

    J & G Foods Recalls Wegmans Organic Ground Beef Due To Plastic Contamination

    J & G Foods is recalling approximately 33,948 pounds of Wegmans Organic ground beef products due to possible contamination with small plastic pieces.

    Product
    Massachusetts Firm Recalls Ground Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • LowFDA (Devices)·Z-0882-2015·2015-01-14

    Alere INRatio 2 Monitors Recalled for Potential Inaccurate INR Results

    Alere San Diego, Inc. is recalling INRatio 2 PT/INR monitors because they may provide results significantly lower than reference laboratory methods.

    Product
    INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0200433 Alere INRatio 2 PT/INR Home Monitoring System - 0200457 Alere INRatio 2 Replacement Monitor - 55112 Alere INRatio 2 Replacement M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15059·2015-01-13

    IKEA Recalls VYSSA Crib Mattresses Due to Entrapment Hazard

    IKEA is recalling VYSSA crib mattresses because they may create gaps larger than allowed by federal regulations, posing an entrapment risk to infants.

    Product
    VYSSA crib mattress
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·007-2015·2015-01-12

    US Foods Recalls Beef Fajita Strips Due to Undeclared Peanuts

    US Foods is recalling approximately 700 pounds of beef fajita strips because the product contains undeclared peanuts, a known allergen.

    Product
    US Foods Inc — New York Firm Recalls Beef Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·15V008000·2015-01-12

    Winnebago Recalls 2014-2015 Motorhomes Due to Tire Pressure Monitoring Defect

    Winnebago is recalling 2014-2015 Trend, Travato, and Itasca Viva motorhomes because the tire pressure monitoring system may fail to detect low tire pressure, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, TREND, ITASCA VIVA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·006-2015·2015-01-09

    Shirks Meats Recalls Pork Sausage Due to Undeclared Peanut Allergen

    Shirks Meats is recalling approximately 1,062 pounds of smoked pork andouille sausage because it contains undeclared peanuts. No adverse reactions have been reported.

    Product
    Timberline Meats, LLC — New York Firm Recalls Pork Sausage Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V005000·2015-01-09

    Ford Recalls Vehicles Due to Fuel Pump Failure Risk

    Ford is recalling certain 2014-2015 vehicles because a defective fuel pump may cause the engine to stall without warning, increasing the risk of a crash.

    Product
    FORD — FORD, LINCOLN FOCUS, ESCAPE, FIESTA, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V006000·2015-01-09

    Ford Recalls 2015 Lincoln MKC Vehicles for Ignition Switch Defect

    Ford is recalling 2015 Lincoln MKC vehicles because the push-to-start button may be pressed accidentally, causing the engine to shut off and increasing crash risk.

    Product
    LINCOLN — LINCOLN MKC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·005-2015·2015-01-08

    Yörök Brand Halal Beef Sausage Recalled for Undeclared Peanuts

    The Daniel Weaver Company is recalling approximately 7,092 pounds of Yörök Brand Halal Beef Soujouk products because they contain undeclared peanuts.

    Product
    (Lebanon) - Godshall's Quality Meats, Inc. — Pennsylvania Firm Recalls Beef Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·004-2015·2015-01-08

    Unibright Recalls Beef and Pork Products Due to Metal Contamination

    Unibright Foods is recalling frozen sukiyaki beef and gingered pork products that may contain metal extraneous materials. No injuries or illnesses have been reported.

    Product
    Unibright Foods, Inc. — California Firm Recalls Beef and Pork Products Due to Foreign Matter Contamination
    Category
    Food
    Distribution
    7 states
  • SevereCPSC·15058·2015-01-08

    SKLZ Resistance Trainers Recalled Due to Risk of Severe Injury

    Pro Performance Sports is recalling SKLZ Recoil 360 Resistance Trainers because a weld can break, causing the cord to retract and injure users or partners.

    Product
    SKLZ Recoil 360™ All-Position Resistance Trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15056·2015-01-08

    CoScentrix Expands Recall of DD Brand Candles Due to Fire Hazard

    CoScentrix is expanding its recall of DD brand candles sold at Hobby Lobby because the high flame can ignite the wax surface, posing a fire hazard.

    Product
    DD brand candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V004000·2015-01-08

    Thor Motor Coach Recalls 2015 Motorhomes Due to Awning Screw Defect

    Thor Motor Coach is recalling 154 model year 2015 motorhomes because defective awning screws could cause the awning to fall and injure people.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR CHATEAU CITATION, PALAZZO, FOUR WINDS 5000, HURRICANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V003000·2015-01-08

    Lance Recalls 2015 Campers and Travel Trailers Due to Awning Bracket Defect

    Lance is recalling 2015 Slide-In Campers and Travel Trailers because awning mounting brackets may crack, causing the awning to fall and potentially injure people.

    Product
    LANCE — LANCE SLIDE-IN CAMPER, TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·003-2015·2015-01-07

    Fresh Food Manufacturing Recalls Chili Products Due to Undeclared Peanuts

    Fresh Food Manufacturing is recalling approximately 35,865 pounds of chili products because they contain undeclared peanuts, a known allergen.

    Product
    Fresh Food Manufacturing Company — Pennsylvania Firm Recalls Chili Product Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0761-2015·2015-01-07

    High Quality Organics Recalls Organic Cilantro Due to Salmonella Risk

    High Quality Organics is recalling Organic Cilantro, Medium, after a customer reported a positive Salmonella test result. The product was distributed to customers in multiple US states and Canada.

    Product
    Organic Cilantro Medium Bulk - size is dependent on customer request; Certified Organic by QAI High Quality Organics Reno, NV; Product of Israel
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-0756-2015·2015-01-07

    Safeway Select French Salted Caramel Ice Cream Recalled for Undeclared Peanut

    Safeway Inc is recalling Safeway Select French Salted Caramel Premium Ice Cream because peanut butter was used in the recipe but not listed on the label.

    Product
    Safeway Select French Salted Caramel (Fleur De Sel) Premium Ice Cream; 1.5 quart round paper carton with lid.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0759-2015·2015-01-07

    Regency Group Recalls Organic Southwest Seasoning Due to Salmonella Risk

    Regency Group, Inc. is recalling Organic Southwest Seasoning and Organic Southwestern Seasoning due to potential contamination with Salmonella. The products were distributed in Oregon and Washington.

    Product
    Organic Southwest Seasoning, Item no. 12785 and Organic Southwestern Seasoning, Item no. 12835, Net Wt. 50 lbs. (22.6 kg). The product is labeled in parts: "***Organic Southwest Seasoning***12785 ***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***". Th
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0757-2015·2015-01-07

    Overhill Farms Recalls Open Nature Chile Cheese Enchiladas Due to Salmonella Risk

    Overhill Farms is recalling Open Nature Chile Cheese Enchiladas because the organic cilantro used in the product may be contaminated with Salmonella.

    Product
    Open Nature Chile Cheese Enchilada Two enchiladas filled with a queso fundido cheese mix topped with guajillo sauce and Mexican cheeses KEEP FROZEN COOK THOROUGHLY NET WT 9 OZ (255 g) COOKING INSTRUCTIONS FOR FOOD SAFETY, FOLLOW THESE COOKING INSTRUCTIONS. PRODUCT
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0758-2015·2015-01-07

    Pride of the Redlands Avocados Recalled for Salmonella Risk

    Unity Groves Corporation is recalling Pride of the Redlands brand Florida green skin avocados because an FDA random sample tested positive for Salmonella.

    Product
    Pride of the Redlands brand Florida green skin avocado, 12ct,14ct, 16ct, 18ct, and 20ct packaged in 1/2 bushel boxes
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0329-2015·2015-01-07

    Ginseng Kianpi Pill Recalled for Undeclared FDA-Approved Drugs

    One and Zen is recalling Ginseng Kianpi Pill capsules because FDA analysis found undeclared dexamethasone and cyproheptadine, making the product an unapproved drug.

    Product
    GINSENG KIANPI PIL, 60 capsules, PRODUCT OF KWEILIN DRUG MANUFACTORY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V002000·2015-01-07

    Polaris Recalls Victory Motorcycles Due to Fuel Pump Defect

    Polaris is recalling certain Victory motorcycles because a manufacturing defect may cause the fuel pump to seize, leading to stalling and an increased risk of a crash.

    Product
    VICTORY — VICTORY HAMMER EIGHT BALL, CROSS ROADS, HIGH BALL, VEGAS EIGHT BALL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0760-2015·2015-01-07

    Regency Group Recalls Organic Cilantro Due to Salmonella Risk

    The Regency Group is recalling Organic Cilantro Cut & Sifted due to potential Salmonella contamination. The product was distributed in Oregon and Washington.

    Product
    Organic Cilantro Cut & Sifted, packaged in 1 lb. or 20 lbs. The product is labeled in parts: "***Organic Cilantro Cut & Sifted***OREGON SPICE COMPANY***13320 NE Jarrett St. Portland, Oregon 97230***".
    Category
    Food
    Distribution
    2 states
  • SevereUSDA FSIS·002-2015·2015-01-07

    Nijiya Market Recalls Frozen Boneless Beef Imported Without Inspection

    Nijiya Market is recalling approximately 359 pounds of frozen boneless beef products produced in Japan that were not presented for USDA inspection at the U.S. point of entry.

    Product
    California Firm Recalls Boneless Beef Products Imported Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0889-2015·2015-01-07

    Roche Recalls ACCU-CHEK Tender II Infusion Sets Due to Tubing Detachment

    Roche Diagnostics is recalling ACCU-CHEK Tender II infusion sets because the tubing may detach, interrupting insulin delivery without an alarm.

    Product
    ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections th
    Category
    Medical Device
    Distribution
    Distributed nationwide

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