The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

Which agencies issued them

201–300 of 1183

  • SevereFDA (Drugs)·D-1236-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling Nitroglycerin Transdermal Systems because they failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V457000·2015-07-22

    Kenworth Trucks Recalled for Reversed Air Brake Line Installation

    PACCAR is recalling 2016 Kenworth trucks because reversed air brake lines may prevent the redundant braking system from working correctly during a failure.

    Product
    KENWORTH — KENWORTH T660, T680, T880, T440
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2847-2015·2015-07-22

    Lion Pavilion Recalls Grassplot Ginger Slices for Undeclared Sulfites

    Lion Pavilion Ltd. is recalling Grassplot Ginger Slices because the product contains undeclared sulfites. Consumers with this product should stop using it.

    Product
    Grassplot Ginger Slice, NET WT. 3.5 OZ. (100g) , UPC 7246 6247, PRODUCT OF CHINA --- Firms on label: Manufactory: Grassplot Foodstuff Factory ADD: Huangshan Road, Huangshan Mansion, suite 417 Shantou, Guangdong, China -- Distributed by: LION PAVILION LIMITED --- Nutrition Facts
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2060-2015·2015-07-22

    Zimmer Recalls ZNN Antegrade Femoral Nail Due to Potential Denting

    Zimmer, Inc. is recalling eight ZNN Antegrade Femoral Nail units because a single distributed unit may have been dented, posing a risk of implant fatigue.

    Product
    ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2082-2015·2015-07-22

    FDA Recalls Autopen Classic Automatic Insulin Delivery Pens Due to Dial Defect

    Owen Mumford USA is recalling Autopen Classic Automatic insulin delivery pens because the dose dial fails to stay set, preventing patients from administering their medication.

    Product
    Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2852-2015·2015-07-22

    Dr. Praeger's Gluten Free Veggie Burgers Recalled for Undeclared Soy

    Ungar's Food Products is recalling Dr. Praeger's Gluten Free California Veggie Burgers because they contain undeclared soy.

    Product
    Dr. Praeger's California Veggie Burgers Gluten Free 11 oz. Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA UPC 080868000602
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA, Inc. is recalling 2,837 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2015·2015-07-22

    Stryker Woundcare Replacement Kits Recalled for Potential Sterility Breach

    Stryker is recalling Woundcare Replacement Kits used for wound debridement due to a potential sterility breach in the packaging.

    Product
    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2842-2015·2015-07-22

    Khara Enterprises Recalls Baked Samosa Sweet Potato for Undeclared Soy

    Khara Enterprises is recalling Baked Samosa Sweet Potato products because they contain undeclared soy lecithin, a major allergen.

    Product
    Baked Samosa Sweet Potato (Baked Indian pastry with a savory filling), Frozen package, Net wt. 7.5 oz., No UPC
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2081-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 131 Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2015·2015-07-22

    Breas Vivo 50 Home Care Ventilator Recalled for Keypad Malfunction

    Breas Medical AB is recalling 846 Vivo 50 Home Care Ventilators because a keypad malfunction can cause the device to stop treatment without an alarm.

    Product
    Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2015·2015-07-22

    Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error

    Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.

    Product
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-2845-2015·2015-07-22

    Ford Gum Recalls Project 7 Caramel Apple Sugar Free Gum for Undeclared Milk

    Ford Gum & Machine Company is recalling Project 7 Caramel Apple Sugar Free Gum because it contains undeclared milk. The product was distributed in California.

    Product
    Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, New York 14001 --- The product was supplied in cardboard bulk boxes. with a label reading, "Project 7 CARAMEL APPLE, approximately 32 pounds Suga
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2089-2015·2015-07-22

    Eizo RadiForce RX850 Medical Monitors Recalled for Display Abnormalities

    Eizo is recalling RadiForce RX850 medical monitors because they may display images abnormally when connected to specific graphics boards using DisplayPort.

    Product
    RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2015·2015-07-22

    Etac Supporter toilet armrest recalled due to loose fasteners

    Etac Supply Center Ab is recalling 25 units of Supporter toilet armrests because fasteners may come loose, causing the product to become unsteady.

    Product
    Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2015·2015-07-22

    Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization

    Sorin Group USA is recalling Stockert Heater-Cooler 3T devices due to the potential for microbial colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2853-2015·2015-07-22

    Kraft Recalls Capri Sun Fruit Punch Juice Drink Blend

    Kraft Foods North America is recalling Capri Sun Fruit Punch Flavored Juice Drink Blend due to possible brass fragments in the product.

    Product
    CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fruit punch (the effected product), wild cherry, pacific cooler, and strawberry kiwi.Fruit Punch Flavored Juice Drink Blend in a blue box with wh
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2077-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 21 Sorin Stockert Heater-Cooler 3T units due to the potential for organism colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2015·2015-07-22

    Northern Digital recalls disposable reflective marker spheres for surgical tracking

    Northern Digital Inc. is recalling 32,400 disposable reflective marker spheres used in Brainlab IGS systems due to inadequate adhesive curing that may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2846-2015·2015-07-22

    Project 7 Recalls Sour Caramel Apple Chewing Gum for Undeclared Milk

    Project 7 is recalling Sour Caramel Apple Chewing Gum because the caramel flavoring contains undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Sour Caramel Apple Chewing, net wt .53 oz, Gum UPC 844911 002919. Sour Caramel Apple chewing gum tablet packed in 12ct metalized PET Pouch with zipper.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2015·2015-07-22

    Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure

    Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.

    Product
    The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2854-2015·2015-07-22

    Natural Grocers Caribbean Fruit & Nut Mix Recalled for Salmonella Risk

    Vitamin Cottage is recalling Natural Grocers Caribbean Fruit & Nut Mix because macadamia nuts in the product may be contaminated with Salmonella.

    Product
    Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2015·2015-07-22

    NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect

    Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V460000·2015-07-22

    Chrysler Recalls 2013-2015 Ram Trucks for Air Bag Deployment Risk

    Chrysler is recalling 2013-2015 Ram 1500, 2500, and 3500 trucks because side air bags and seat belts may deploy unexpectedly, increasing crash risk.

    Product
    RAM — RAM 3500, 2500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary imp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V459000·2015-07-22

    Chrysler Recalls Ram Trucks Due to Air Bag Wiring Harness Defect

    Chrysler is recalling 2012-2014 Ram trucks because a steering wheel wiring harness may rub against the air bag retainer, potentially causing unexpected air bag deployment.

    Product
    DODGE — DODGE, RAM RAM 5500, 4500, RAM 4500, RAM 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2015·2015-07-22

    Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk

    Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.

    Product
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V456000·2015-07-22

    Peterbilt Trucks Recalled for Alternator Cable Chafing Fire Risk

    PACCAR is recalling 2012-2016 Peterbilt trucks because alternator cables may chafe against a metal line, creating a fire risk.

    Product
    PETERBILT — PETERBILT 388, 365, 367, 384
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2058-2015·2015-07-22

    Biomet Recalls 50 A.L.P.S. Cortical Locking Screws Due to Packaging Defect

    Biomet, Inc. is recalling 50 A.L.P.S. 3.5mm x 60 mm Cortical Locking Screws because the sterile packaging was not sealed, posing a risk of infection.

    Product
    A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·15V458000·2015-07-22

    Kenworth Trucks Recalled for Hazard Light Override Defect

    PACCAR is recalling 2011-2016 Kenworth trucks because daytime running lamps may override hazard warning lights, increasing crash risk.

    Product
    KENWORTH — KENWORTH T440, T470, T880, T680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2015·2015-07-22

    Exactech Spine Set Screw Recalled for Incorrect Thread Form

    Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.

    Product
    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2851-2015·2015-07-22

    Tortilleria Provincia Recalls Blue Corn Tortillas Due to Labeling Error

    Tortilleria Provincia is recalling Blue Corn Tortillas because the packaging incorrectly lists ingredients and color additives intended for other tortilla varieties.

    Product
    Tortilleria Provincia Refrigerate After Purchase Blue Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2849-2015·2015-07-22

    Tortilleria Provincia White Corn Tortillas Recalled for Labeling Error

    Tortilleria Provincia is recalling White Corn Tortillas because the packaging labels were incorrectly shared with other tortilla varieties, resulting in inaccurate ingredient and color listings.

    Product
    Tortilleria Provincia Refrigerate After Purchase White Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2065-2015·2015-07-22

    Biomet Oxford Femoral Drill Guide Recalled for Undersized Diameter

    Biomet is recalling 18 Oxford Femoral Drill Guide Lateral IM Adapters because an undersized diameter may interfere with a specific IM Link component.

    Product
    Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial repla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2015·2015-07-22

    Nidek Green Laser Photocoagulator Accessories Recalled for Missing Labels

    Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.

    Product
    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1241-2015·2015-07-22

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is recalling Ketorolac Tromethamine Injections because crystallization was identified as the calcium salt of Ketorolac.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2015·2015-07-22

    Synthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect

    Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for TFNA because an oversized pin prevents the tool from passing through the guide sleeve.

    Product
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2850-2015·2015-07-22

    Tortilleria Provincia Yellow Corn Tortillas Recalled for Labeling Error

    Tortilleria Provincia is recalling Yellow Corn Tortillas because the packaging labels were incorrectly used for Blue corn tortillas, creating a labeling discrepancy.

    Product
    Tortilleria Provincia Refrigerate After Purchase Yellow Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2843-2015·2015-07-22

    Del Campo Alino Casero Seasoning Paste Recalled for Undeclared Preservatives

    Megabusiness LLC is recalling Del Campo Alino Casero Seasoning Paste because it contains undeclared preservatives, Benzoic Acid and Sorbic Acid.

    Product
    Del Campo Alino Casero Seasoning Paste, 15oz; Product Code: 03138; UPC: 7 751227 000894. Product is in a glass bottle.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1242-2015·2015-07-22

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is recalling specific lots of Ketorolac Tromethamine Injection due to the presence of crystals identified as the calcium salt of Ketorolac.

    Product
    KETOROLAC TROMETHAMINE — KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2015·2015-07-22

    Agfa Healthcare Recalls Two IMPAX Agility Medical Imaging Systems

    Agfa Healthcare is recalling two IMPAX Agility PACS units in Missouri due to a software error that displayed incorrect patient names.

    Product
    IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, repor
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2070-2015·2015-07-22

    Exactech Recalls Four Ambassador Cervical Plate Systems

    Exactech, Inc. is recalling four Ambassador Cervical Plate Systems that were shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by hist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2074-2015·2015-07-22

    Nobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error

    Nobel Biocare is recalling 149 units of Zirconia Abutment Retrieval Instruments and Kits because a dimensional error prevents the instruments from removing metal adapters as intended.

    Product
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2015·2015-07-22

    Eizo RadiForce RX650 LCD Monitor Recalled for Display Abnormalities

    Eizo is recalling RadiForce RX650 LCD monitors that may display abnormally when connected to specific graphics boards using DisplayPort.

    Product
    RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2015·2015-07-22

    Synthes Recalls 16mm Chisel Blades Due to Incorrect Size Marking

    Synthes (USA) Products LLC is recalling 100 units of 16mm Chisel Blades that were incorrectly etched as 16mm when they are actually 10mm.

    Product
    16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2075-2015·2015-07-22

    Musculoskeletal Transplant Foundation Recalls Allofix Insertion Kits Due to Drill Size Labeling Error

    Musculoskeletal Transplant Foundation is recalling 117 Allofix Insertion Kits because they are labeled as 2.0mm but may contain 2.4mm drills.

    Product
    Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2844-2015·2015-07-22

    Sysco Mandarin Oranges Recalled for Carbendazim Residue

    Sysco Corporation is recalling 292 cases of Whole Segments Mandarin Oranges in Light Syrup because the product tested positive for Carbendazim.

    Product
    Sysco International Whole Segments Mandarin Oranges In Light Syrup Net Wt. 6 LB 10 OZ (3.01 kg) NDC: 074865629065; 6 cans per case
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Food)·F-2848-2015·2015-07-22

    Dr. Pepper Snapple Recalls Diet Bubba Cola Due to Labeling Errors

    Dr. Pepper Snapple Group is recalling Diet Bubba Cola because the label fails to declare specific ingredients and displays the wrong product type.

    Product
    Diet Bubba Cola, 20 FL. OZ (1.25 PT) 591 mL INGREDIENTS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, CARAMEL COLOR, PHOSPHORIC ACID, NATURAL FLAVOR, CAFFEINE. DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD. EARTH CITY, MO 63045 0 51933 34484 6
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2087-2015·2015-07-22

    Eizo RadiForce GX540 Monitors Recalled for Display Abnormalities

    Eizo is recalling 19 RadiForce GX540 monitors that may display abnormally when connected to specific graphics boards with DisplayPort.

    Product
    RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1237-2015·2015-07-22

    Kremers Urban Recalls Nitroglycerin Transdermal Patches Due to Impurity Failure

    Kremers Urban Pharmaceuticals is recalling 16,504 boxes of Nitroglycerin Transdermal Systems because two lots failed impurity specifications during stability testing.

    Product
    Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 6
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2068-2015·2015-07-22

    Nidek GYC-1000 Laser Accessories Recalled for Missing Labels

    Nidek Inc is recalling GYC-1000 laser accessories because they are missing Laser Aperture labels. The affected units were distributed to 13 US states.

    Product
    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation,
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2071-2015·2015-07-22

    Exactech Single Barrel Drill Guides Recalled for Incomplete Final Inspection

    Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was completed.

    Product
    Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2090-2015·2015-07-22

    BD Biosciences Recalls Flow Cytometers for Missing Laser Safety Labeling

    BD Biosciences is recalling 2,188 flow cytometers installed between June 2007 and September 2011 because they lack required FDA laser safety labeling.

    Product
    BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1239-2015·2015-07-22

    Qualitest Recalls HydrOXYzine Tablets Due to Unreadable Identification Codes

    Qualitest Pharmaceuticals is recalling HydrOXYzine Hydrochloride 25 mg tablets because some identification codes are unreadable.

    Product
    HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1238-2015·2015-07-22

    Geritrex Recalls Carb-O-Philic 40 Cream Due to Container Closure Deviation

    Geritrex Corp is recalling Carb-O-Philic 40 Cream due to a CGMP deviation involving poor container closure of the bulk storage container.

    Product
    Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2066-2015·2015-07-22

    Tosoh Glycohemoglobin Analyzer Buffer Recalled for Incorrect Expiration Date Labeling

    Tosoh Bioscience is recalling G7 Variant Elution Buffer HiS no. 1 (M) because it is labeled with an expiration date of October 2015 instead of the correct October 2014.

    Product
    G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1235-2015·2015-07-22

    Desmopressin Acetate Tablets Recalled for Incorrect Imprint

    American Health Packaging is recalling Desmopressin Acetate Tablets because some are incorrectly imprinted with an X on one side.

    Product
    Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalCPSC·15189·2015-07-21

    Acorn Stairlifts Recalls Motorized Stair Lifts Due to Fall Hazard

    Acorn Stairlifts is recalling about 34,500 motorized stair lifts because the seat post can separate from the main support, posing a fall hazard.

    Product
    Motorized stair lifts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·15188·2015-07-21

    Target Recalls Circo Night Lights Due to Fire Hazard

    Target is recalling about 143,000 Circo Night Lights because the battery can overheat and cause the light to melt, posing a fire hazard.

    Product
    Circo Night Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V454000·2015-07-21

    Allied Recreation Recalls 2016 Motorhomes Due to Propane Regulator Defect

    Allied Recreation Group is recalling 92 model year 2016 motorhomes because an incorrect propane regulator may allow moisture buildup, potentially causing a gas leak and fire.

    Product
    FLEETWOOD — FLEETWOOD, MONACO, HOLIDAY RAMBLER TIOGA RANGER, TREK, TERRA SE, STORM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V451000·2015-07-20

    Mazda Recalls 2007-2014 CX-9 Vehicles for Front Suspension Defect

    Mazda is recalling 2007-2014 CX-9 vehicles because front suspension ball joints may corrode, potentially causing loss of steering control and increasing crash risk.

    Product
    MAZDA — MAZDA CX-9
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E061000·2015-07-17

    SAF-Holland Recalls CBX Series Trailer Suspension Systems for Pivot Bolt Failure

    SAF-Holland is recalling CBX series trailer suspension systems because pivot bolts may fail, potentially causing the axle to separate from the trailer and increasing crash risk.

    Product
    SUSPENSION:REAR:AXLE:NON-POWERED AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V450000·2015-07-17

    BMW Recalls 2014-2015 MINI Cooper Models for Side Impact Defect

    BMW is recalling 2014-2015 MINI Cooper, Cooper S, and John Cooper Works vehicles because rear seats fail federal side impact safety standards, increasing injury risk.

    Product
    MINI — MINI JOHN COOPER WORKS, COOPER S, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15742·2015-07-17

    EKO Recalls Motion Sensor Trash Cans Due to Laceration Hazard

    EKO is recalling motion sensor trash cans sold at Costco because a protective collar can dislodge, exposing a sharp edge that poses a laceration risk.

    Product
    Trash cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15E062000·2015-07-17

    H&H Sports Protection Recalls VCAN V528 Milano Motorcycle Helmets

    H&H Sports Protection is recalling VCAN V528 Milano motorcycle helmets because the retention systems failed testing and required labeling is missing.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15T014000·2015-07-17

    Continental ContiProContact Tires Recalled for Bead Air Leak Defect

    Continental is recalling specific ContiProContact tires manufactured in early 2015 because a manufacturing error may cause air leaks from the bead area, increasing the risk of sudden tire failure and a crash.

    Product
    TIRES:BEAD recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15187·2015-07-16

    Cash Acme Heatguard TAFR Devices Recalled Due to Scald Hazard

    Reliance Worldwide is recalling Cash Acme Heatguard TAFR devices because a thermal failure could cause scalding injuries. About 26,000 units are affected.

    Product
    Cash Acme Heatguard Temperature Actuated Flow Reducing (TAFR) Device
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1211-2015·2015-07-15

    Baxter Recalls Lactated Ringers Bags Due to Metal Particulate Matter

    Baxter Healthcare is recalling specific lots of Lactated Ringers Injection due to the presence of metal particulate matter.

    Product
    LACTATED RINGERS — LACTATED RINGERS (SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • CriticalUSDA FSIS·100-2015·2015-07-15

    Murry's Recalls Gluten-Free Chicken Nuggets Due to Staphylococcal Enterotoxin

    Murry's, Inc. is recalling approximately 20,232 pounds of Bell & Evans gluten-free breaded chicken nuggets due to staphylococcal enterotoxin contamination.

    Product
    Murry's, Inc., Recalls Chicken Products Due to Staphylococcal Enterotoxin Contamination
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1951-2015·2015-07-15

    Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2790-2015·2015-07-15

    United Salad Recalls Champ's Sliced Crimini Mushrooms for Listeria Risk

    United Salad Company is recalling Champ's Sliced Crimini Mushrooms due to potential Listeria monocytogenes contamination. The product was distributed in Oregon and Washington.

    Product
    Champ's Sliced Crimini Mushrooms, net weight 227 gram (8 oz), UPC 6 78286 88877 5. The product's label is read in parts: "***Champ's Mushrooms***Sliced Crimini Mushrooms***KEEP REFRIGERATED***Product of Canada***Aldergrove. B.C V4W 2Z6***".
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1207-2015·2015-07-15

    SLIM-K Capsules Recalled for Unapproved Dangerous Ingredients

    Bethel Nutritional Consulting is recalling SLIM-K capsules because FDA testing found unapproved ingredients including sibutramine and phenolphthalein.

    Product
    SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1210-2015·2015-07-15

    Baxter Recalls 10% Dextrose Injection Bags Due to Metal Particulate Matter

    Baxter Healthcare is recalling 18,324 bags of 10% Dextrose Injection due to the presence of metal particulate matter. The affected products were distributed in the US, Puerto Rico, and Bermuda.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-2817-2015·2015-07-15

    Redwood Hill Farm Raw Milk Feta Recalled for Listeria

    Redwood Hill Farm is recalling one lot of Raw Milk Feta because it tested positive for Listeria monocytogenes.

    Product
    Redwood Hill Farm Raw Milk Feta; Artisan Goat Cheese; Perishable, keep refrigerated. Ingredients: Raw goat milk, sea salt, Vegetarian enzyme, cultures. Packaged in a 3 lb. plastic bucket (in brine), Two buckets per case. Handmade in Sebastopol, CA Redwood Hill Farm & Cream
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2816-2015·2015-07-15

    Garden Fresh Potato Salad Kit Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Steakhouse Potato Salad Kits after one case tested presumptive for Listeria monocytogenes. The product was distributed in Illinois.

    Product
    Garden Fresh Steakhouse Potato Salad Kit, CODE#1076, NET WT 10.75 LBS (4.876 KG) , UPC 0 01 11596 51076 4.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1089-2015·2015-07-15

    Teva Recalls Adrucil Fluorouracil Injection Due to Particulate Matter

    Teva Pharmaceuticals is recalling Adrucil (fluorouracil injection) vials due to the presence of black particulate matter, including silicone rubber and drug crystals.

    Product
    Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1216-2015·2015-07-15

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira is recalling Bupivacaine Hydrochloride Injection vials because they contain free-floating and embedded iron oxide particles.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E060000·2015-07-15

    Flex-A-Lite Recalls Electric Fan Kits Due to Fire Risk

    Flex-A-Lite is recalling specific electric fan kits because missing fuse holders and insufficient circuit breakers may cause electrical damage and vehicle fires.

    Product
    ENGINE AND ENGINE COOLING:COOLING SYSTEM:FAN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2788-2015·2015-07-15

    Kerry Foods Recalls Nondairy Creamer Due to Potential Metal Fragments

    Kerry Foods is voluntarily recalling specific lots of nondairy creamer produced in May 2015 due to the potential presence of small metal pieces from a broken production screen.

    Product
    Kraft French Vanilla, Creamer, Non-Dairy Creamer, Net WT/Contenido Neto 35.3 oz (1 kg) SKU 2100002971. Publix, Nondairy, FrenchVanilla, Naturally and Artificially Flavored Coffee Creamer, Net Wt 15 oz (425 g), SKU 4141501625.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1989-2015·2015-07-15

    Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides

    Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.

    Product
    Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2818-2015·2015-07-15

    Popcorn Factory Recalls Dill Pickle Popcorn Due to Undeclared Milk Allergen

    The Popcorn Factory is recalling Dill Pickle Lite Works Popcorn because it contains milk, an allergen not declared on the label.

    Product
    Dill Pickle Lite Works Popcorn , lot number 15111, packaged in a 4 oz foil white bag with black and green lettering.
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·15182·2015-07-15

    Cooper Lighting Recalls Fluorescent Fixtures Due to Fire Hazard

    Cooper Lighting is recalling about 1.62 million fluorescent fixtures because the sockets can overheat, arc, and melt, posing a fire hazard.

    Product
    Cooper Lighting, Portfolio and Utilitech fluorescent lighting fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2046-2015·2015-07-15

    Biomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects

    Biomet is recalling 75 A.L.P.S. Foot Locking Calcaneus Plates because thread defects may cause screws to back out or shear, potentially requiring revision surgery.

    Product
    A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-2426-2015·2015-07-15

    New Punjab Chum Chum Recalled for Undeclared Allergens and Colors

    New Punjab Sweets Inc. is voluntarily recalling Chum Chum snacks due to undeclared almonds, coconut, wheat, and food colors.

    Product
    New Punjab Chum Chum is a oval-shaped Indian snack coated with almonds and/or coconuts. Product is packaged in clear plastic container with a clear plastic lid. Container sizes are 1lb. and 0.5lbs.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2832-2015·2015-07-15

    D.A.M Brand Mild Salsa Recalled for Peanut Contamination

    Paradigm Foodworks is recalling D.A.M brand Mild Salsa due to potential peanut protein contamination. Consumers should check lot codes and stop using the product.

    Product
    Mild Salsa, D.A.M brand, Net Wt. 16 oz (453 g), UPC 1-87283-00001-6
    Category
    Food
    Distribution
    4 states

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