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.

101–200 of 1028

  • CriticalFDA (Food)·F-0739-2015·2014-12-24

    Ortega Taco Sauce Recalled for Potential Peanut and Almond Contamination

    B&G Foods is recalling Ortega Taco Sauce and other products because spice ingredients may contain undeclared peanuts and almonds.

    Product
    Ortega Taco Sauce - Medium 8 oz, UPC 39000-01892, 16 oz. UPC 39000-01894.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V819000·2014-12-24

    GM Recalls 2015 Silverado and Sierra Trucks for Rear Axle Fracture Risk

    General Motors is recalling specific 2015 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because the rear axle shaft may fracture, potentially causing the rear wheel to separate.

    Product
    GMC — GMC, CHEVROLET SIERRA, SILVERADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2015·2014-12-24

    Hospira Recalls Meropenem I.V. Vials Due to Defective Glass

    Hospira Inc. is recalling Meropenem I.V. 1 g vials because thin glass walls may crack, leading to contamination and sterility issues.

    Product
    Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactured by Hospira Healthcare India Pvt. Ltd Tamil Nadu, India for Hospira, Inc. 275 N. Field Drive, Lake Forest, IL 60045. NDC 0409-3506-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0824-2015·2014-12-24

    Zimmer Manufacturing Recalls Self-Tapping Bone Screws Due to Fracture Risk

    Zimmer Manufacturing B.V. is recalling 6,377 self-tapping bone screws used in hip surgery due to fractures caused by specific tool marks.

    Product
    Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0738-2015·2014-12-24

    B&G Foods Recalls Ortega and Las Palmas Taco Sauces for Allergen Risk

    B&G Foods is recalling Ortega and Las Palmas Taco Sauce products because spice ingredients may contain undeclared peanuts and almonds.

    Product
    Taco Sauce - Mild sold under the following brands: 1. Ortega 8 oz, UPC 39000-00890, 16 oz. UPC 39000-01893; 2. Las Palmas 8 oz. UPC 41501-79890 and (Canada) 226 g. UPC 41501-79990.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V820000·2014-12-24

    GM Recalls 2015 Silverado HD and Sierra HD Diesel Trucks for Fuel Leak Risk

    General Motors is recalling specific 2015 Chevrolet Silverado HD and GMC Sierra HD diesel trucks because a loose hose clamp may cause a fuel leak, increasing fire risk.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO HD, SIERRA HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V818000·2014-12-24

    Mercedes-Benz Recalls 2015 E-Class Vehicles for Rear Seat Belt Defect

    Mercedes-Benz is recalling 2015 E-Class vehicles because the rear middle seat belt buckle could fail in a crash, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E350, E63, E250, E400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0710-2015·2014-12-24

    Solgar Infant Powder Recalled for Rhizopus oryzae Fungi Presence

    NBTY is recalling Solgar Enhanced Series ABC Dophilus Powder for infants and children due to the presence of Rhizopus oryzae fungi.

    Product
    SOLGAR ENHANCED SERIES ABC DOPHILUS POWDER FOR INFANTS AND CHILDREN, NET WT. 1.75 oz (50 g), UPC 0 33984 00010 0. Carefully Manufactured by: Solgar, Inc., 500 Willow Tree Road Leonia, NJ 07605 U.S.A.
    Category
    Food
    Distribution
    30 states
  • SevereFDA (Food)·F-0714-2015·2014-12-24

    House of Flavors Recalls Dark Cocoa Sorbetto for Undeclared Milk

    House of Flavors is recalling Dark Cocoa Sorbetto because it contains undeclared milk, a major allergen. This follows one reported consumer complaint of an allergic reaction to dairy.

    Product
    Dark Cocoa Sorbetto packed in 14 oz. plastic jars, 8 packages per case, manufactured from 4/11/14-4/12/14; product code: EB/JP, L3, 26-426, 14102, BEST BY October 12, 2015, BEST BY 10/15.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0716-2015·2014-12-24

    Farmer Brand Dried Lily Flowers Recalled for Undeclared Sulfites

    Blooming Import Inc. is recalling Farmer Brand Dried Lily Flowers because the product contains undeclared sulfites.

    Product
    Farmer Brand DRIED LILY FLOWERS, NET WT. 8 oz, UPC 7 34765 04089 5 -- PRODUCT OF CHINA -- DISTRIBUTED BY BLOOMING IMPORT 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- Nutrition Facts: Serving Size 0.4 oz. Servings Per Container 20 --- The product is packaged in a sealed flexible…
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0720-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, and related desserts due to potential Listeria monocytogenes contamination.

    Product
    Peach Melba Whipped Cream Pie, 34 oz., UPC 7789033104
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0828-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2015·2014-12-24

    Philips EPIQ 5 Ultrasound System Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 5 Ultrasound Systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or delayed therapy.

    Product
    EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 5G, EPIQ 5C, EPIQ 5W. Catalog Number: 795204 / 795205 and Part Number: 989605408541 Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Food)·F-0726-2015·2014-12-24

    Wegmans Recalls Sliced Nectarines and Peaches for Listeria Risk

    Wegmans is recalling sliced nectarines, plums, peaches, and related products due to potential Listeria monocytogenes contamination.

    Product
    Sliced Yellow Nectarines, made fresh in-store and packaged. Sold pre-packaged in random weights.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0818-2015·2014-12-24

    Philips Q-Station Software Recalled for Potential Incorrect Cardiac Measurements

    Philips is recalling Q-Station 3.0 software because automated cardiac measurements may be inaccurate, potentially leading to misdiagnosis or incorrect therapy.

    Product
    Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0817-2015·2014-12-24

    Philips EPIQ 7 Ultrasound Systems Recalled for Incorrect Ejection Fraction Calculations

    Philips is recalling EPIQ 7 ultrasound systems because specific software plug-ins may calculate incorrect ejection fractions, potentially leading to misdiagnosis or incorrect therapy.

    Product
    EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: EPIQ 7G, EPIC 7C, EPIQ 7W; Catalog Number: 795200 / 795201 and Part Number: 989605386721. Diagnostic Ultrasound Imaging.
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0808-2015·2014-12-24

    Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0451-2015·2014-12-24

    GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss

    GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.

    Product
    Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0722-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Baked Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Lg. Fruit Strip "Puff Pastry", 11 oz., UPC 20829200000; Sm. Fruit Strip "Puff Pastry", 3 oz., UPC 20829100000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0754-2015·2014-12-24

    Stryker Johann Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2015·2014-12-24

    Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire

    Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.

    Product
    Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0453-2015·2014-12-24

    GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems

    GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.

    Product
    Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0829-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.

    Product
    RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0743-2015·2014-12-24

    HyVee Mozzarella Sticks Recalled for Undeclared Soy and Dyes

    Great American Appetizers is recalling HyVee Mozzarella Sticks because the product contains soy flour and dyes not listed on the label.

    Product
    Mozzarella cheese sticks are breaded Mozzarella Stick designed to be cooked in either the oven or a fryer. The package contains a clear inner plastic sealed bag with the food product, inside a cardboard larger carton. The net weight is 8 oz., and there are 12 units per case.…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0807-2015·2014-12-24

    Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0825-2015·2014-12-24

    DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery

    DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.

    Product
    Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0815-2015·2014-12-24

    Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations

    Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.

    Product
    Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0236-2015·2014-12-24

    Philips Brilliance iCT Computed Tomography System Software Defect Recall

    Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0728-2015·2014-12-24

    Kozy Shack Chocolate Pudding Recalled for Undeclared Milk

    Kozy Shack is recalling Simply Well Chocolate Pudding due to undeclared milk and incomplete labeling. The recall affects 1,774 cartons distributed across 20 states.

    Product
    KOZY SHACK SIMPLY WELL CHOCOLATE, NET WT 4 OZ. Product packed in brown carton box, 48 individual units x 4 OZ. Keep Refrigerated. Made in USA
    Category
    Food
    Distribution
    20 states
  • HighFDA (Drugs)·D-0301-2015·2014-12-24

    Baxter Recalls Clinimix E IV Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 7,220 bags of Clinimix E IV solution because leaks were observed, raising concerns about sterility.

    Product
    CLINIMIX E — CLINIMIX E (LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0729-2015·2014-12-24

    Whalen's Seafood Sauce Recalled for Undeclared Anchovies

    Whalen's Seafood & Burger Sauce is being recalled because it contains undeclared anchovies and has incomplete ingredient labeling.

    Product
    WHALEN'S SEAFOOD & BURGER SAUCE "HOT", NET WT. 8 OZ. (226 g) -- Whalen's Horseradish Products, LLC, PO Box 4700, Saratoga Springs, New York 12866
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0725-2015·2014-12-24

    Wegmans Recalls Fresh Sliced Peaches, Plums, Nectarines, and Desserts

    Wegmans is voluntarily recalling fresh sliced peaches, plums, nectarines, peach salsa, and in-store baked desserts due to potential Listeria monocytogenes contamination.

    Product
    Sliced Yellow Peaches, made fresh in-store and packaged. Sold pre-packaged in random weights.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0805-2015·2014-12-24

    AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns

    American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.

    Product
    AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0800-2015·2014-12-24

    Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts

    Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.

    Product
    DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0724-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Vanilla Trifle, 8 oz., UPC 7789080600
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0803-2015·2014-12-24

    Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture

    Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.

    Product
    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0508-2015·2014-12-24

    Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk

    Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.

    Product
    Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0718-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Baked Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Small Fruit-Topped Cheese Cake, 18 oz., UPC 7789026441 Large Fruit-Topped Cheese Cake, 54 oz., UPC 7789026438 Fruit-Topped Cream Cheese Pie, 40 oz., UPC 7789018953
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0801-2015·2014-12-24

    Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors

    Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.

    Product
    Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0830-2015·2014-12-24

    Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors

    Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.

    Product
    RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2015·2014-12-24

    Siemens Biograph mCT Scanners Recalled for Potential Display Freeze

    Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0809-2015·2014-12-24

    Siemens Biograph mCT X-4R Recalled for Potential Display Freeze During Procedures

    Siemens Medical Solutions is recalling eight Biograph mCT X-4R scanners due to a possibility of system display freeze during CT interventional procedures.

    Product
    Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0721-2015·2014-12-24

    Wegmans Recalls Fresh Fruit and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and specific in-store baked tarts due to potential Listeria monocytogenes contamination.

    Product
    Peach Melba Tart, 26 oz., UPC 7789098553; Rectangular Fruit Tart, 37 oz., UPC 20823800000; Mixed Fruit Tart, 30 oz., UPC 20819500000; Square Fruit Tart, 48 oz., UPC 20823700000; Frangipane Tart, 30 oz., UPC 7789091064
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0723-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Lg. Fruit Crostata, 21 oz., UPC 20829300000; Sm. Fruit Crostata, 7 oz., UPC 20829900000; Lg. Nectarine Crostata, 21 oz., UPC 20823100000; Sm. Nectarine Crostata, 6 oz., UPC 20832600000
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0811-2015·2014-12-24

    Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk

    Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential system display freeze during CT interventional procedures.

    Product
    Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0759-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of 3mm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2015·2014-12-24

    GE Healthcare Recalls Discovery IGS 740 Imaging Systems Due to Loss of Function

    GE Healthcare is recalling Discovery IGS 740 systems because they may lose real-time imaging or motion capabilities due to electromagnetic sensitivity.

    Product
    Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0821-2015·2014-12-24

    Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error

    Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.

    Product
    VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0717-2015·2014-12-24

    Wegmans Recalls Fresh Fruit and Peach Salsa Due to Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Wegmans Peach Salsa, made fresh in-store and packaged in random weights.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0719-2015·2014-12-24

    Wegmans Recalls Fresh Stone Fruits and Baked Desserts for Listeria Risk

    Wegmans is voluntarily recalling fresh plums, nectarines, peaches, peach salsa, and in-store baked desserts that may contain these fruits due to potential Listeria monocytogenes contamination.

    Product
    Fruit-Topped Short Cake, 1/4 sheet, 49 oz., UPC 7789032772; Genoise Cake, 1/4 sheet, 64 oz., UPC 7789027385
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0765-2015·2014-12-24

    Stryker Endoscopy Recalls 180,573 Cobra Grasper Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 Cobra Grasper instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2015·2014-12-24

    Stryker Endoscopy Recalls Schertel Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Schertel Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, SCHERTEL FORCEPS, BLUNT FENESTRATED, P/N 0250080072. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0676-2015·2014-12-24

    Stryker Debaney Forceps Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of Debaney Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0626-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, RING HANDLE, P/N 0250080236. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0610-2015·2014-12-24

    Stryker Endoscopy Recalls Hasson Cannula Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Hasson Cannula units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0718-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0657-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0685-2015·2014-12-24

    Stryker Laparoscopic Grasper Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0785-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0751-2015·2014-12-24

    Stryker Laparoscopic Dissector Recall Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic dissectors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080761 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2015·2014-12-24

    Stryker Endoscopy Recalls Bullet Forceps Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of Bullet Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0702-2015·2014-12-24

    Stryker Endoscopy Recalls Mini Metzenbaum Scissors Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of Mini Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0710-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0706-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 laparoscopic forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, DISSECTING & GRASPER FORCEPS, SERRATED, 45CM, P/N 0250080579 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0593-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2015·2014-12-24

    Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Dissecting Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic dissecting forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 33CM INSERT, DISSECTING FORCEPS, P/N 0250080760 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0659-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0670-2015·2014-12-24

    Stryker Blakesly Biopsy Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Blakesly Biopsy Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BLAKESLY BIOPSY FORCEPS, P/N 0250080292. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0717-2015·2014-12-24

    Stryker Laparoscopic Instruments Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0650-2015·2014-12-24

    Stryker Dolphin Forceps Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling Dolphin Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0646-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Endo Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0649-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MICRO SCISSORS, CURVED, P/N 0250080270. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0684-2015·2014-12-24

    Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Documentation Errors

    Stryker Endoscopy is recalling 180,573 units of Babcock Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BABCOCK FORCEPS, P/N 0250080321. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Metzenbaum scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0774-2015·2014-12-24

    Stryker Endoscopy Recalls 3mm PEEK Multi-Function Handle Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Multi-Function Handles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0642-2015·2014-12-24

    Stryker Endoscopy Recalls Metzenbaum Scissors Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0813-2015·2014-12-24

    Integra LifeSciences Recalls Non-Radiopaque PyroSphere CMC and TMT Implants

    Integra LifeSciences is recalling 19 units of PyroSphere CMC and TMT implants because they are non-radiopaque, potentially limiting post-surgical imaging.

    Product
    Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the first metacarpal and the trapezium and 4th/5th tarsometatarsal where degenerative of post-traumatic arthritis presents. Size 10; Catalogue No. PCS-430-10-WW
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0767-2015·2014-12-24

    Stryker Laparoscopic Grasper Recall Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic blunt graspers because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BLUNT GRASPER, 20CM, P/N 0250282009 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0781-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2015·2014-12-24

    Stryker Baby Metzenbaum Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Baby Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0733-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, ENDO GRASPER, 45CM, P/N 0250080726 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0669-2015·2014-12-24

    Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling biopsy forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0602-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0699-2015·2014-12-24

    Stryker Laparoscopic Trocar Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic trocars because the instructions for use do not support specific sterilization methods.

    Product
    PKG, TROCAR, 12.5MM, PYRAMIDAL TIP, P/N 0250080422. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0595-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0682-2015·2014-12-24

    Stryker Endoscopy Recalls 33cm Dorsey Grasper Forceps Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of 33cm Dorsey Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0668-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of 5mm atraumatic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0734-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, PADDLE BABCOCK, 45CM, P/N 0250080727 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0629-2015·2014-12-24

    Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Babcock Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BABCOCK FORCEPS, P/N 0250080241. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2015·2014-12-24

    Stryker Endoscopy Recalls Bowel Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Bowel Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282104 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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