The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
272
High
309
Moderate
311
Low
64

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

Which agencies issued them

101–200 of 1028

  • CriticalFDA (Food)·F-0727-2015·2014-12-24

    Wake-Up Instant Coffee Mix Recalled for Undeclared Milk Allergen

    Evershing International Trading Inc. is recalling Wake-Up Instant Coffee Mix because testing found undeclared milk allergen.

    Product
    Wake-Up Instant Coffee Mix (weasel coffee) Melange de Cafe Instantane Ca Phe Hoa Tan (huong caon) 3 in one; sold in two packing configurations: 1. 20 bags x (0.6 oz) 17g in Plastic Bag 2. 18 bags x (0.6 oz) 17g in Paper Box. Original ingredient statement: Non-Dairy Cr
    Category
    Food
    Distribution
    5 states
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 plast
    Category
    Food
    Distribution
    6 states
  • 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 is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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-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 (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 (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) ports
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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 lyi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 ang
    Category
    Medical Device
    Distribution
    0 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 (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 w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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 information
    Category
    Medical Device
    Distribution
    2 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 (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-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-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 Safety
    Category
    Medical Device
    Distribution
    32 states
  • 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-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 (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
  • 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-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 (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 (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. Prod
    Category
    Food
    Distribution
    1 state
  • 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 (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-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 (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 (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-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) p
    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-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 (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 generat
    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
  • ModerateFDA (Drugs)·D-0299-2015·2014-12-24

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules

    Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.

    Product
    Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0655-2015·2014-12-24

    Stryker Endoscopy Recalls Mixter Forceps Due to Sterilization Instructions

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

    Product
    PKG, MIXTER FORCEPS, P/N 0250080285. 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-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 (RF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0608-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions

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

    Product
    PKG, MIXTER FORCEPS, P/N 0250080010. 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-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) p
    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-0730-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

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

    Product
    PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 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 all
    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 rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0696-2015·2014-12-24

    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 0250080362. 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-0603-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Trocars Due to Sterilization Documentation Issues

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

    Product
    PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; 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-0700-2015·2014-12-24

    Stryker Endoscopy Recalls 10mm Clip Applying Forceps Due to Sterilization Documentation

    Stryker Endoscopy is recalling 180,573 units of 10mm Clip Applying Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. 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 (Food)·F-0713-2015·2014-12-24

    Tastefully Simple Recalls Cookies & Cream Fudge Due to Mold

    Tastefully Simple is recalling specific lots of Cookies & Cream Fudge because mold is growing on the chocolate cookie pieces.

    Product
    Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2 samples of a second product not being recalled. The product comes in small plastic container with lid (3.5" x 2.5" x 21.875"). A small spoon i
    Category
    Food
    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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

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

    Product
    PKG, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 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 fre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0742-2015·2014-12-24

    Beachbody Base Shake Recalled for Mislabeling as Fuel Shot

    Beachbody is recalling specific lots of Hardcore Base Shake because some bottles were incorrectly labeled as Fuel Shot due to a labeling error at the contract manufacturer.

    Product
    Beachbody Hardcore Base Shake Lot #42932B22, #42931A22, and #42902B22 Black HDPE container with Black Lid. Label stated weight of 1 lb. 12.2 oz. (800 g.) Lot code information located on the bottom of the container in yellow ink.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0780-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

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

    Product
    PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 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) p
    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 whic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0728-2015·2014-12-24

    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, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 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-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 wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0639-2015·2014-12-24

    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, PKG, HOOK SCISSORS, P/N 0250080260. 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-0597-2015·2014-12-24

    Stryker Laparoscopic Biopsy Forceps Recalled for Sterilization Documentation Error

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

    Product
    PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 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 whic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0690-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

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

    Product
    PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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-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-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-0671-2015·2014-12-24

    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, SPOON W/PIN, P/N 0250080293. 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) p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2015·2014-12-24

    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,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 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-0789-2015·2014-12-24

    Stryker Dorsey Grasper Recall Due to Sterilization Instructions

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

    Product
    PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 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-0831-2015·2014-12-24

    Integra Licox Brain Tissue Oxygen Monitoring Catheters Recalled for Inaccurate Values

    Integra LifeSciences is recalling 2,506 Licox brain tissue oxygen monitoring catheters because they contain a smart card programmed with an inaccurate lkN2 value.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of
    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) ports
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions

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

    Product
    PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. 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-0783-2015·2014-12-24

    Stryker Laparoscopic Grasper Recall Due to Sterilization Instructions

    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, 29CM, P/N 0250282056 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 w
    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 al
    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 to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors

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

    Product
    PKG, MIXTER FORCEPS, P/N 0250080249. 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-0722-2015·2014-12-24

    Stryker Endoscopy Recalls 3.5mm Cannula Packages Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3.5mm cannula packages because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N 0250080634 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 (R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2015·2014-12-24

    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, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 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 (Drugs)·D-0300-2015·2014-12-24

    Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements

    American Health Packaging is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 680
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

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

    Product
    PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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 whic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2015·2014-12-24

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Due to Performance Issues

    JAS Diagnostics Inc. is recalling 390 units of Glucose Hexokinase (Liquid) Reagent because the product does not perform according to specifications.

    Product
    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0693-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled Due to Sterilization Parameter Errors

    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, PADDLE, 45CM, P/N 0250080351. 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 wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0770-2015·2014-12-24

    Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions

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

    Product
    PKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 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-0737-2015·2014-12-24

    Stryker Endoscopy Recalls Fenestrated Forceps Due to Sterilization Instructions

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

    Product
    PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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-0793-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Instructions

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

    Product
    PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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 fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0727-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling 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, 33CM, P/N 0250080699 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 wh
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.