The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
200
High
218
Moderate
235
Low
36

Of the 766 recalls this month scored against our rubric, 10% are Critical, 26% are Severe.

Which agencies issued them

501–600 of 766

  • ModerateFDA (Devices)·Z-2393-2016·2016-08-17

    Siemens AXIOM Artis Angiography Systems Recalled for Cooling System Contamination

    Siemens is recalling AXIOM Artis angiography systems because biomass contamination in the cooling system may damage the pump.

    Product
    AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Artis, Artis zee / zeego and Artis Q/ Q.zen are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2369-2016·2016-08-17

    Philips Brilliance 16 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 203 Brilliance 16 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-2370-2016·2016-08-17

    Philips Brilliance CT 16 Power Systems Recalled for Software Defect

    Philips Medical Systems is recalling 55 Brilliance CT 16 Power systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    46 states
  • LowFDA (Devices)·Z-2378-2016·2016-08-17

    BD Tritest CD3/CD4/CD45 Reagent Recalled for Incorrect Labeling

    Becton, Dickinson and Company is recalling 14,089 vials of BD Tritest CD3 FITC/CD4 PE/CD45 PerCP because the label incorrectly states the product contains gelatin.

    Product
    BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and 0.1% sodium azide. Hematology: BD Tritest CD3 fluorescein isothiocyanate (FITC)/CD4 phycoerythrin (PE)/CD45 peridinin chlorophyll…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2345-2016·2016-08-17

    Medivance ArcticGel Neonatal Pad Recalled for Missing Multilingual Instructions

    C.R. Bard is recalling 64 Medivance ArcticGel Neonatal Pads because the included instructions were missing required languages for CE-marked products.

    Product
    Medivance ArcticGel Neonatal Pad The pad is designed to fit into an incubator and provide whole body cooling for patients.
    Category
    Medical Device
    Distribution
    13 states
  • HighNHTSA·16V606000·2016-08-16

    KME Predator Emergency Vehicles Recalled for Front Grille Separation Risk

    Kovatch Mobile Equipment is recalling 27 KME Predator emergency vehicles from 2012-2013 because the front grille may loosen and separate from the cab, creating a road hazard.

    Product
    KME — KME PREDATOR AERIAL, PREDATOR PUMPER, PREDATOR RESCUE, PREDATOR PANTHER PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V603000·2016-08-16

    Mercedes-Benz Recalls 2016 C300 and GLC300 for Electronic Stability Control Defect

    Mercedes-Benz is recalling 2016 C300 and GLC300 vehicles because a damaged Electronic Stability Program control unit may activate stability control or disable the parking brake, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C300, GLC300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V599000·2016-08-15

    Autocar Recalls 2016-2017 Xspotter Vehicles for Steering Column Defect

    Autocar is recalling 294 model year 2016-2017 Xspotter vehicles because a steering column shaft weld may break, causing a loss of steering ability and increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XSPOTTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V601000·2016-08-15

    Spartan Motors Recalls 2014-2016 Legend and Star Fire Trucks

    Spartan Motors is recalling 2014-2016 Legend and Star fire trucks due to a transmission defect that may prevent power output switching, risking injury.

    Product
    SPARTAN ERV — SPARTAN ERV LEGEND, STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V600000·2016-08-15

    Keystone Recalls 2011-2017 Bullet and Passport Trailers for Fire Risk

    Keystone is recalling 2011-2017 Bullet and Passport recreational trailers because an improperly wired air conditioner thermostat may cause an electrical short and fire.

    Product
    KEYSTONE — KEYSTONE PASSPORT, BULLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V602000·2016-08-15

    Mercedes-Benz Recalls 2016 GLE450 for Rear Head Restraint Defect

    Mercedes-Benz is recalling 2016 GLE450 vehicles because rear head restraints may not stay locked in very low temperatures, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V596000·2016-08-12

    Toyota Recalls RAV4 and Lexus HS 250h for Rear Suspension Defect

    Toyota is recalling 2006-2011 RAV4 and 2010 Lexus HS 250h vehicles because improperly tightened rear suspension arms may fail, causing loss of vehicle control.

    Product
    TOYOTA — TOYOTA, LEXUS RAV4, HS 250 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V597000·2016-08-12

    Harbor Freight Recalls Haul Master Trailers for Rear Lamp Bracket Defect

    Harbor Freight is recalling 2006-2016 Haul Master trailers because incorrectly positioned rear lamp brackets may fail to illuminate the license plate, increasing crash risk.

    Product
    HAUL MASTER — HAUL MASTER TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V598000·2016-08-12

    Winnebago Recalls 2015-2017 Recreational Vehicles Due to Electrical Fire Risk

    Winnebago is recalling 2015-2017 Itasca and Winnebago recreational vehicles because a loose electrical connection may cause heat buildup and increase the risk of a fire.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA FUSE, CAMBRIA, ASPECT, TRAVATO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16T011000·2016-08-12

    Goodyear Recalls Dunlop SP50 Tires Due to Tread Chunking Risk

    Goodyear is recalling specific Dunlop SP50 tires manufactured between December 2012 and February 2014 because they may experience tread chunking, which increases the risk of a crash.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V593000·2016-08-11

    Mazda Recalls CX-7 Vehicles Due to Front Suspension Corrosion Risk

    Mazda is recalling 2007-2012 CX-7 vehicles because water and salt may cause front suspension ball joints to corrode and separate, potentially leading to a loss of steering control.

    Product
    MAZDA — MAZDA CX-7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V595000·2016-08-11

    GM Recalls 2016 Buick Verano Vehicles Due to Fuel Line Fire Risk

    General Motors is recalling 2016 Buick Verano vehicles because a misrouted fuel line may contact the engine, wear, and leak fuel, increasing the risk of a fire.

    Product
    BUICK — BUICK VERANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1856-2016·2016-08-10

    Windy Acres Fruity Trail Mix Recalled for Listeria Risk

    Windy Acres is recalling Fruity Trail Mix because the sunflower kernels may be contaminated with Listeria monocytogenes.

    Product
    Windy Acres FRUITY TRAIL MIX Roasted Peanuts, Pineapple, Papaya, Raisins & Almonds 7 OZ (198 G) UPC 0 82987 02016 5 WILMINGTON, OH 45177 1-937-382-8057
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1853-2016·2016-08-10

    ACH Food Companies Recalls Salad Toppings for Listeria Risk

    ACH Food Companies is recalling Durkee, Hy-Vee, and Food Club salad toppings because an ingredient may be contaminated with Listeria monocytogenes.

    Product
    Salad topping labeled under the following brand names: (Product 1) Durkee Salad Topping in plastic bottle, Net Wt. 6.75 oz (192 g), packed in cases of 12. UPC 047600091366. The responsible firm name on the label is ACH Food Companies, Inc. Memphis, TN; (Product 2) Hy-Vee…
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1855-2016·2016-08-10

    Windy Acres Sunflower Seeds Recalled for Listeria Contamination

    Windy Acres Candy & Nut, Outlet Inc. is recalling specific lots of roasted, no-salt sunflower seeds due to potential Listeria monocytogenes contamination.

    Product
    ROAST, NO SALT SUNFLOWER SEEDS sold under the following brands: Jungle Jim 16oz (453G) INGREDIENTS: SUNFLOWER SEEDS ROASTED IN SUNFLOWER AND OR PEANUT OIL UPC 0 82987 05874 8 & Windy Acres 8 OZ (22 G) UPC 0 82987 30172 1 & 5 lb plastic bag WILMINGTON, OH 45177
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1870-2016·2016-08-10

    Marin Food Specialties Recalls Raw Macadamia Nuts Due to Salmonella Risk

    Marin Food Specialties is recalling raw macadamia nuts sold at Whole Foods in four western states after an FDA sample tested positive for Salmonella.

    Product
    Raw Macadamias, 6 oz. clear plastic tubs, NET WT (170g) Whole Foods: Distributed by Whole Foods Market, Emeryville, CA: Ingredients: Macadamia Nuts; contains tree nuts. Product of Malawi: UPC: 9 99482 00132 5
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1860-2016·2016-08-10

    Club Chef Recalls Diced and Sliced Yellow Onions Due to Listeria

    Club Chef LLC is recalling diced and sliced yellow onions because a customer reported that whole uncut product tested positive for Listeria.

    Product
    Diced and sliced yellow onions. 2.5 lb & 5 lb clear plastic bags
    Category
    Food
    Distribution
    17 states
  • CriticalFDA (Food)·F-1859-2016·2016-08-10

    Cumberland Farms Chocolate Treats Recalled for Undeclared Peanuts

    New American Food Products is recalling Cumberland Farms Farmhouse Premium Chocolate Treats because they contain peanuts, an undeclared allergen.

    Product
    Cumberland Farms Farmhouse Premium Chocolate Treats - Sea Salt Carmel Delights, 3 oz. bag
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1862-2016·2016-08-10

    Creative Snacks Brain Food Recalled for Potential Listeria Monocytogenes

    Creative Snacks Co. is recalling Brain Food products due to the potential presence of Listeria monocytogenes. The recall covers specific snack bags, bulk, and cup products distributed in 14 states.

    Product
    Creative Snacks Brain Food, 3.5 oz. Snack Bag, UPC 816512015124, 10 lb. Bulk, UPC 816512013021, 9.5 oz. cup, UPC 855983002073; Fresh Market Brain Food, 25 lb. Bulk, UPC N/A, 9.5 oz. cup, UPC 737094218270,
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-1868-2016·2016-08-10

    Creative Snacks Hold the Salt! Recalled for Potential Listeria

    Creative Snacks Co. is recalling Hold the Salt! products due to the potential presence of Listeria monocytogenes.

    Product
    Creative Snacks Co. Hold the Salt!, 10 lb. bulk, UPC 816512011201; Creative Snacks Co. Hold the Salt!, 8.5 oz. cup, UPC 816512011034
    Category
    Food
    Distribution
    14 states
  • SevereNHTSA·16V592000·2016-08-10

    Tadano Recalls 2013-2015 All-Terrain Cranes Due to Air Line Defect

    Tadano is recalling 2013-2015 all-terrain crane trucks because an improperly assembled air line connection may cause reduced braking or loss of mobility.

    Product
    TADANO — TADANO ATF70G-4, ATF220G-5, ATF130G-5, ATF400G-6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2339-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 90 units of Air Dermatome II Width Plates because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1857-2016·2016-08-10

    Nature's Harmony Cherokee Rose Cheese Recalled for Salmonella Contamination

    Nature's Harmony LLC is recalling Cherokee Rose Hand Made cheese due to Salmonella contamination. The product was distributed only to food service establishments in Georgia.

    Product
    Cherokee Rose Hand Made cheese, Produced by Natures Harmony in Berton, GA 30635.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1866-2016·2016-08-10

    Creative Snacks Sunny Day Splendor Recalled for Potential Listeria

    Creative Snacks Co. is recalling Sunny Day Splendor snack products due to the potential presence of Listeria monocytogenes.

    Product
    Creative Snacks Co. Sunny Day Splendor, 10 lb. bulk, UPC 816512014653; Creative Snacks Co. Sunny Day Splendor 10 oz. cup, UPC 816512010983
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2215-2016·2016-08-10

    Draeger Recalls Oxylog 3000 Pediatric Patient Circuits Due to Leakage

    Draeger Medical is recalling Oxylog 3000 disposable pediatric patient circuits because isolated episodes of leakage were found at the check valve.

    Product
    Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Dr¿ger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1858-2016·2016-08-10

    Fresh Market Nut Mix Recalled for Undeclared Peanuts and Soy

    Creative Snacks Co. is recalling The Fresh Market Smoked Supreme Nut Mix because it contains undeclared peanuts and soy.

    Product
    The Fresh Market, Smoked Supreme Nut Mix, Net Wt. 12.3 oz. (349g), Distributed by: The Fresh Market, Inc., Greensboro, NC 27408, packed in clear plastic package.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1861-2016·2016-08-10

    Meduri Farms Recalls Dried Blueberries Due to Peanut Contamination

    Meduri Farms Inc is recalling dried blueberries due to potential peanut protein contamination. The recall covers bulk packages distributed in the US and internationally.

    Product
    Meduri Farms Dried Blueberries/Sugar Infused, Catalog #s: 080282, 08028X, 08028, 080281, 08127X. Product is packaged in a BULK corrugated box with food grade plastic liner, net weight 10 lbs., 20 lbs., and 25 lbs.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1865-2016·2016-08-10

    Creative Snacks and Plentiful Planet Sunflower Seeds Recalled for Listeria Risk

    Creative Snacks Co. is recalling specific lots of roasted, no salt sunflower seeds due to the potential presence of Listeria monocytogenes.

    Product
    Creative Snacks Co. Roasted, No Salt Sunflower Seeds, 9 oz. cup, UPC 816512011294; 10 lb. bulk, UPC 816512011423; Plentiful Planet Roasted, No Salt Sunflower Seeds, 25 lb. bulk, UPC 07742417794; 10 lb. bulk, UPC 077420000880
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-1871-2016·2016-08-10

    Honey Bunchies Gourmet Honey Bars Recalled for Listeria Risk

    Honey Bunchie, LLC is voluntarily recalling Honey Bunchies Gourmet Honey Bars due to potential Listeria monocytogenes contamination in sunflower kernels.

    Product
    Honey Bunchies Gourmet Honey Bars, 1.9 oz. snack bar containing honey, sunflower kernels, peanuts and pecans. Packaging: Box containing 20 individual bars in plastic wrappers. Manufactured by: Honey Bunchie, LLC, Longmont, CO. Individual Bar UPC 8 66192 00010 1; Box of 20 Bars…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1854-2016·2016-08-10

    Zupan Enterprises Recalls Macaroni Salad with Cheddar Cheese Due to Listeria Risk

    Zupan Enterprises is recalling Macaroni Salad with Cheddar Cheese due to potential Listeria monocytogenes contamination from affected green peas.

    Product
    Macaroni Salad with Cheddar Cheese is packaged in a plastic bag, each case contains 2/5 lbs. bags. The label listed item #23070 and the UPC 8 87241 80712 0. The product was also sold both in Zupans Markets service deli salad case, sized to order, and available in prepacked…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2255-2016·2016-08-10

    Olympus Analytical X-Ray Systems Recalled for Trigger Lock Failure

    Olympus Scientific Solutions Americas is recalling Analytical X-Ray Systems because the trigger lock may fail to prevent x-ray generation in test modes.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: Analytical X-Ray System X -Ray Fluorescence. Intended to emit ionizing radiation Delta with models: DC-2000, DC-4000, DC-6000, DI-2000, DP-2000, DP-4000, DP-4050, DP- 6000, DPO-4000, DPO-6000, DS-2000…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·070-2016 EXP·2016-08-10

    Al Shabrawy Recalls Meat and Poultry Products Due to Undeclared Allergens

    Al Shabrawy Inc. is recalling various meat and poultry products because they contain undeclared pistachio and soy allergens and are misbranded.

    Product
    Al Shabrawy Inc. — Al Shabrawy Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Food)·F-1864-2016·2016-08-10

    Creative Snacks Heart Smart Mix Recalled for Listeria Risk

    Creative Snacks Co. is recalling Heart Smart Mix products due to the potential presence of Listeria monocytogenes.

    Product
    Plentiful Planet Heart Smart Mix, 25 lb. bulk, UPC 030684710285; Publishers Clearing House Heart Smart Mix 8 oz. bag, UPC n/a; Creative Snacks Co. Heart Smart 3.5 oz. Snack Bags, UPC 816512012130; Creative Snacks Co. Heart Smart 9.5 oz. cup, UPC 855983002066; Creative Snacks Co.…
    Category
    Food
    Distribution
    14 states
  • SevereNHTSA·16V590000·2016-08-10

    Jeep Cherokee Recall for Loose Seat Fasteners

    Chrysler is recalling 2014-2016 Jeep Cherokee vehicles because seat fasteners may not be tightened correctly, increasing injury risk in a crash.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1452-2016·2016-08-10

    Let's Talk Health Recalls Unapproved Oxygen Nasal Wash Solution

    Let's Talk Health is recalling 417 bottles of Oxygen Nasal Wash because the product was marketed without FDA approval and does not comply with nasal decongestant monograph requirements.

    Product
    Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1867-2016·2016-08-10

    Creative Snacks Sunflower Seeds Recalled for Listeria Risk

    Creative Snacks Co. is recalling specific lots of roasted, salted sunflower seeds due to the potential presence of Listeria monocytogenes.

    Product
    Creative Snacks Co. Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 816512013892; Plentiful Planet Roasted, Salted Sunflower Seeds, 10 lb. bulk, UPC 077420000873; Creative Snacks Co. Roasted, Salted Sunflower Seeds, 9 oz. cup, UPC 816512011218
    Category
    Food
    Distribution
    14 states
  • HighCPSC·16242·2016-08-10

    Dennis East International Recalls Whiskey Glass and Stone Sets

    Dennis East International is recalling whiskey glass and stone sets because the glass can break during use, posing a laceration risk.

    Product
    Whiskey Glass and Stone Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2016·2016-08-10

    Merge HEMO software recall for inaccurate INR display

    Merge Healthcare is recalling 37 units of Merge HEMO software because the displayed International Normalized Ratio (INR) value does not match the imported value.

    Product
    Merge HEMO software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1849-2016·2016-08-10

    Lance Oyster Crackers Recalled for Potential Peanut Residue

    S-L Snacks NC, LLC is recalling Lance Oyster Crackers because they may contain low levels of peanut residue.

    Product
    Lance Oyster Crackers, Dist. by Snyder's-Lance, Inc., Charlotte, NC 28277
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-2343-2016·2016-08-10

    Spacelabs Ultraview SL Command Module Recalled for NIBP Failure

    Spacelabs Healthcare is recalling Ultraview SL Command Modules because the Non-Invasive Blood Pressure (NIBP) parameter may become non-functional and display error messages.

    Product
    91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1873-2016·2016-08-10

    Kroger Deluxe Ice Cream S'mores Recalled for Undeclared Peanut Residue

    The Kroger Co is recalling Kroger Deluxe Ice Cream S'mores because it may contain undeclared peanut residue. The product was distributed to 29 states.

    Product
    Kroger DELUXE ICE CREAM S'MORES 48 FL OZ (1.5 QT) 1.4 ML INGREDIENTS: ICE CREAM***GRAHAM COOKIES***CHOCOLATE CHUNKS***CONTAINS: MILK, SOY, WHEAT, COCONUT. UPC 0 11110 01399 6 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202
    Category
    Food
    Distribution
    29 states
  • HighFDA (Devices)·Z-2305-2016·2016-08-10

    Philips MultiDiagnost Eleva X-Ray System Recalled for Potential Bolt Failure

    Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts attaching the clamping plate may break, causing the C-arm to sag.

    Product
    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16243·2016-08-10

    Shocker RSX Paintball Markers Recalled for Chamber Ejection Risk

    Shocker Paintball is recalling RSX markers with blue main chambers because the part can unexpectedly eject from the rear, posing a risk of impact injury.

    Product
    Shocker RSX paintball markers/guns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2016·2016-08-10

    Stryker Recalls Spirit Plus Hospital Beds Due to Actuator Failure

    Stryker Medical is voluntarily recalling Spirit Plus hospital beds because broken actuators may cause the bed to lower unexpectedly, risking patient injury.

    Product
    Spirit Plus Bed, A-C Powered Hospital Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2016·2016-08-10

    Zimmer Biomet Recalls V-TEK Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 V-TEK Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.

    Product
    V-TEK TWIST D 40X90MM 30MM Cann 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2312-2016·2016-08-10

    NeoCoil 3T 16ch Flex SPEEDER Large Coil Recalled for Surface Temperature Risk

    NeoCoil, LLC is recalling 39 units of the 3T 16ch Flex SPEEDER Large Coil due to a potential for higher than specified surface temperatures.

    Product
    3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems Model MJAJ-222A. The NeoCoil 3T 16ch Flex SPEEDER Coils are tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2307-2016·2016-08-10

    Philips MultiDiagnost Eleva X-Ray System Recalled for Bolt Failure Risk

    Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts may break, causing the C-arm to sag. The recall covers units distributed worldwide.

    Product
    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2016·2016-08-10

    Philips IntelliVue Patient Monitor Recall for Outdated Waveform Data

    Philips is recalling IntelliVue Patient Monitors because they may display outdated waveform data if powered on continuously for several months, failing to reflect current patient conditions.

    Product
    IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2016·2016-08-10

    Zimmer Biomet Recalls Twist Drills Due to Tolerance Stack Up

    Zimmer Biomet is voluntarily recalling 169 Twist Drills because a potential tolerance stack up was identified between the drill and the mating Kirschner Wire component.

    Product
    TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2332-2016·2016-08-10

    Stryker Recalls Spirit Select and Plus Hospital Beds Due to Actuator Failure

    Stryker Medical is voluntarily recalling Spirit Select and Spirit Plus hospital beds because broken actuators may cause the bed to lower unexpectedly, risking patient injury.

    Product
    Spirit Select Bed, A-C Powered Hospital Bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1454-2016·2016-08-10

    Isomeric Pharmacy Recalls Betamethasone Injectable Suspension Due to Particle Issues

    Isomeric Pharmacy Solution is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension due to potential drug clumps and larger particle sizes.

    Product
    Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2016·2016-08-10

    Beckman Coulter Recalls AU480 Chemistry Analyzers Due to Leaking C Cups

    Beckman Coulter is recalling AU480 Chemistry Analyzers because leaking C cups can cause coolant to short-circuit the instrument's circuit boards.

    Product
    AU480 Chemistry Analyzers, Reference No. B28624 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2016·2016-08-10

    Beckman Coulter AU5800 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU5800 Chemistry Analyzers because cracked C cups can leak coolant onto circuit boards, causing short-circuits and instrument stop mode.

    Product
    AU5800 Chemistry Analyzers, Reference No. A98352 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 90 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2330-2016·2016-08-10

    Dako EnVision FLEX+ Mouse High pH Kits Recalled for pH Error

    Dako Denmark A/S is recalling 147 kits of EnVision FLEX+ Mouse, High pH (Link) because the Target Retrieval Solution has an incorrect pH level.

    Product
    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2303-2016·2016-08-10

    Merge PACS Software Recall for Annotation Display Defect

    Merge Healthcare is recalling Merge PACS 6.0 software because it fails to display annotations on certain loaded studies.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2325-2016·2016-08-10

    BK Medical bk3500 Ultrasound Scanner Recalled for Volume Calculation Error

    B-K Medical A/S is recalling six bk3500 ultrasound systems because the generic volume measurement function may display incorrect calculations, potentially affecting diagnostic accuracy.

    Product
    BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2336-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 70 units of Air Dermatome II Width Plates because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 . Width plates is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2335-2016·2016-08-10

    Zimmer Air Dermatome II Handpiece Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 220 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2016·2016-08-10

    Medtronic StealthStation Software Recalled Due to Scanner Compatibility Issues

    Medtronic Navigation is voluntarily recalling 27 units of StealthStation software due to compatibility issues with specific floor-based scanners.

    Product
    MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2016·2016-08-10

    Medtronic Navigation Recalls Synergy Cranial S7 Software Applications

    Medtronic Navigation is conducting a voluntary field action for Synergy Cranial S7 software applications due to compatibility issues with specific floor-based scanners.

    Product
    Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2304-2016·2016-08-10

    Roche Recalls Vancomycin Assay Kits Due to Incorrect Method Sheets

    Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.

    Product
    ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2016·2016-08-10

    Medtronic Navigation StealthStation Software Voluntary Field Action

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2338-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 60 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2016·2016-08-10

    Mentor MemoryGel Breast Implant Recall Due to Missing Date Labels

    Mentor Texas, LP is recalling 35 units of 300cc MemoryGel Breast Implants because the boxes were labeled with null manufacturing and expiration dates.

    Product
    Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateUSDA FSIS·071-2016·2016-08-10

    Sam Kane Beef Processors Recalls Ground Beef Due To Metal Contamination

    Sam Kane Beef Processors is recalling approximately 60,350 pounds of Hill Country Fare ground beef products due to possible metal contamination.

    Product
    Sam Kane Beef Processors, LLC Recalls Ground Beef Products Due To Possible Foreign Material Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2329-2016·2016-08-10

    AccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors

    AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.

    Product
    6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2334-2016·2016-08-10

    Zimmer Air Dermatome II Handpieces Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 630 Air Dermatome II handpieces because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2016·2016-08-10

    Medtronic Navigation Recalls Fusion ENT Software Application

    Medtronic Navigation is voluntarily recalling 27 units of the Fusion ENT software application due to a field action involving Neurologica scanners.

    Product
    Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2016·2016-08-10

    Zimmer Biomet Recalls V-Tek Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 V-Tek Twist Drills because a potential tolerance stack-up was identified between the drill and the mating Kirschner Wire component.

    Product
    V-TEK TWIST D 3.5X90MM 30MM Can 12MM Rnd; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2302-2016·2016-08-10

    Ortho-Clinical Diagnostics Recalls VITROS Total T4 Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.

    Product
    VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2016·2016-08-10

    Implant Direct Recalls RePlant Angled Abutments Due to Design Defect

    Implant Direct Sybron Manufacturing is recalling 205 RePlant Angled Abutments because they are oversized due to a design specification issue.

    Product
    RePlant¿ Angled Abutment Part Number 6050-52-60
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2318-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is voluntarily recalling StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2016·2016-08-10

    Zimmer Air Dermatome II Width Plate Recalled for Surface Coating Defects

    Zimmer Surgical Inc is recalling 110 units of the Air Dermatome II Width Plate because the surface coating is blistering, peeling, and discoloring after use.

    Product
    Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2301-2016·2016-08-10

    Merge PACS software recall for missing patient data in telmed studies

    Merge Healthcare is recalling specific versions of Merge PACS software because studies received via telmed were missing patient DOB, procedure, and referring physician information.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2322-2016·2016-08-10

    Zimmer Biomet Recalls Twist Drills Due to Tolerance Issues

    Zimmer Biomet is voluntarily recalling 169 Twist Drills and V-Tek Twist Drills because of a potential tolerance stack-up issue with Kirschner Wire components.

    Product
    TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2314-2016·2016-08-10

    Medtronic Navigation Recalls StealthStation Software Applications

    Medtronic Navigation is conducting a voluntary field action for StealthStation software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2016·2016-08-10

    Medtronic Navigation Recalls S7 MACH FrameLink Software Applications

    Medtronic Navigation is conducting a voluntary field action for S7 MACH FrameLink software applications affected by Neurologica BodyTom/CereTom floor-based scanners.

    Product
    S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2016·2016-08-10

    Beckman Coulter AU680 Chemistry Analyzers Recalled for Leaking C Cups

    Beckman Coulter is recalling AU680 Chemistry Analyzers because leaking and cracked C cups can cause coolant to leak onto circuit boards, resulting in short-circuits and instrument stop mode.

    Product
    AU680 Chemistry Analyzers, Reference No. B04779 The AU series are automated, clinical chemistry analyzers that measure analytes in patient samples (serum, plasma, urine, CSF) in combination with appropriate reagents, calibrators, quality, control (QC) materials, and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1453-2016·2016-08-10

    Teva Recalls Children's Qnasl Nasal Aerosol for Content Uniformity Failure

    Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.

    Product
    Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2333-2016·2016-08-10

    C.R. Bard Recalls SureStep Urine Collection System for Labeling Issues

    C.R. Bard is recalling 530 SureStep urine collection systems due to a labeling problem. The recall is voluntary and nationwide.

    Product
    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2327-2016·2016-08-10

    Teleflex Horizon 24 Titanium Clips Recalled for Missing Date Labels

    Teleflex Medical is recalling Horizon 24 Large Titanium Clips because manufacturing and expiration dates are missing from the blister pack labels.

    Product
    Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, Sterile. The metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. An implantable clip…
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2311-2016·2016-08-10

    Branan Medical Recalls AmediCheck Instant Test Cups Due to Packaging Error

    Branan Medical is recalling AmediCheck Instant Test Cups because they may erroneously contain 12-panel cups due to a packaging error.

    Product
    AmediCheck Instant Test Cup, Part No. C-C0501A-3A Product Usage: The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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