The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

401–500 of 766

  • HighNHTSA·16V609000·2016-08-22

    Keystone Recalls 2017 Cougar Trailers for Incorrect Tire Load Range

    Keystone is recalling 2017 Cougar recreational trailers because they may have incorrect Federal Identification Tags or tires with the wrong load range, which could lead to tire failure.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·072-2016·2016-08-21

    Panna Cafe Express Recalls Uninspected Meat and Poultry Products

    Panna Cafe Express To Go Inc. is recalling approximately 1,951 pounds of meat and poultry products produced without federal inspection and using unauthorized USDA marks.

    Product
    Panna Cafe Express To Go Inc. Recalls Various Meat and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1881-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Breast Melt Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Oven Roasted Turkey Breast & Cheese Melt on Knot Roll sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Oven Roasted Turkey Breast & Cheese Melt on Knot Roll Code #C02272/02272
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1901-2016·2016-08-17

    Let's Do Lunch Recalls Teriyaki Burger Patties for Listeria Risk

    Let's Do Lunch, Inc. is recalling Teriyaki Burger Beef Patties due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service Teriyaki Burger Beef Patty on a Whole Grain Hawaiian Bun Code #C48008
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1893-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Turkey Breast & Cheese Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain Ciabatta Roll Code #C16006/160006
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1885-2016·2016-08-17

    Let's Do Lunch Turkey Bologna Sandwich Recalled for Listeria Risk

    Let's Do Lunch, Inc. is recalling Turkey Bologna & Cheese Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service Turkey Bologna & Cheese Sandwich Turkey Bologna on a whole Grain French Roll Code #C12001/120001
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1887-2016·2016-08-17

    Let's Do Lunch Turkey Ham and Cheese Sandwich Recall for Listeria

    Let's Do Lunch, Inc. is recalling Integrated Food Service Turkey Ham & Cheese Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Hawaiian Bun Code #130018/C13018
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1880-2016·2016-08-17

    Cafe Favorites Turkey Ham & Cheese Submarine Recalled for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Turkey Ham & Cheese Submarines due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Turkey Ham & Cheese Submarine Code #C02184/02184
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1878-2016·2016-08-17

    Let's Do Lunch Turkey Ham & Cheese Sandwiches Recalled for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Turkey Ham & Cheese Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Ham & Cheese Sandwich Code #C13001/130001
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1884-2016·2016-08-17

    Let's Do Lunch Recalls Super Sub Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites 5" Super Sub sandwiches due to potential Listeria monocytogenes contamination. The products were distributed nationwide in the U.S.

    Product
    Cafe Favorites 5" Super Sub on a Whole Grain Hoagie-IW Code #C02384/02384
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1890-2016·2016-08-17

    Let's Do Lunch Recalls Submarine Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Submarine Sandwiches on Whole Grain Ciabatta Rolls due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Submarine Sandwich on a Whole Grain Ciabatta Roll Code #C14006/140006
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1876-2016·2016-08-17

    Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist Recalled for Listeria

    Let's Do Lunch, Inc. is recalling Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist products due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Turkey Ham, Egg & Cheese Sunrise Twist Code #C51140/51140
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1904-2016·2016-08-17

    Let's Do Lunch Recalls Beef Sausage and Cheese Mini Bagels

    Let's Do Lunch, Inc. is recalling beef sausage and cheese mini bagels due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service Beef Sausage & Cheese on a Mini Bagel Code #809016/C80916-CH Code #C80916
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1913-2016·2016-08-17

    Let's Do Lunch Recalls Beef Sausage Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling beef sausage sandwiches due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service Beef Sausage Sandwich Beef Sausage Patty on a Whole Grain Hawaiian Bun Code #990018
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1911-2016·2016-08-17

    Let's Do Lunch Recalls Chicken Hot Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chicken Hot Dogs due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Low Sodium, Reduced Fat Chili Cheese Dog Chicken Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Bun Code #C95200/952000
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1894-2016·2016-08-17

    Cafe Favorites Turkey Breast Deli Flatz Recalled for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Oven Roasted Turkey Breast & Cheese Deli Flatz due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Oven Roasted Turkey Breast & Cheese Deli Flatz-IW Code #C22348/22348
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1879-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Ham and Cheese Melt Sandwiches

    Let's Do Lunch, Inc. is recalling Cafe Favorites Turkey Ham & Cheese Melt on a Knot Roll sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Turkey Ham & Cheese Melt on a Knot Roll Code #C02172/02172
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1900-2016·2016-08-17

    Let's Do Lunch Recalls Cheese Burgers for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service All American Cheese Burgers due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service All American Cheese Burger Beef Patty and Cheese on a Whole Grain Bun Code #471007/C47107-CH
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1912-2016·2016-08-17

    Let's Do Lunch Recalls Chili Cheese Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Original Wienerschnitzel Chili Cheese Dogs due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Original Wienerschnitzel Chili Cheese Dog All Meat Hot Dog with Chili & Cheese on a Whole Grain Hot Dog Code #C96100/960000
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1897-2016·2016-08-17

    Let's Do Lunch Recalls BBQ Rib Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling BBQ Rib Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service BBQ Rib Sandwich BBQ Rib Beef Patty on a Whole Grain Roll Code #460007
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1888-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling specific turkey sandwiches due to potential Listeria monocytogenes contamination. The products were distributed nationwide in the U.S.

    Product
    Integrated Food Service Submarine on a French Roll Turkey Bolo, Turkey Salami and Cheese on a Whole Grain French Roll Code #C14001/140001
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1892-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling specific turkey breast and cheese sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Breast & Cheese Sandwich on a Whole Grain French Roll Code #C16001/160001
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1899-2016·2016-08-17

    Let's Do Lunch Recalls Cheeseburger Sliders for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Cheeseburger Sliders due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Cheeseburger Sliders Mini Slider Beef Patty and Cheese on a Whole Grain Bun Code #470220/C47220-CH
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1902-2016·2016-08-17

    FDA Recalls Turkey Sausage and Cheese Twist for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Turkey Sausage & Cheese Sunrise Twist due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Turkey Sausage & Cheese Sunrise Twist Code #C52140/52140
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1886-2016·2016-08-17

    Let's Do Lunch Turkey Ham and Cheese Sandwiches Recalled for Listeria

    Let's Do Lunch, Inc. is recalling specific Turkey Ham & Cheese Sandwiches on Whole Grain Knot Rolls due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Ham & Cheese Sandwich on a Whole Grain Knot Roll Code #130008/C13008
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1891-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Breast Combo Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Turkey Breast Combo sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Breast Combo on a Whole Grain Knot Roll Code #C15008/150008
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1905-2016·2016-08-17

    Let's Do Lunch Recalls Chicken Double Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chicken Double Dogs on Whole Grain Buns due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chicken Double Dogs on Whole Grain Buns Code #809021
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1908-2016·2016-08-17

    Let's Do Lunch Recalls Bean and Cheese Chalupa for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Bean & Cheese Chalupa due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Integrated Food Service Bean & Cheese Chalupa-Bulk Code #C82705/827005
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1883-2016·2016-08-17

    Let's Do Lunch Recalls Cold Cut Combo Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Cold Cut Combo sandwiches due to potential Listeria monocytogenes contamination. The products were distributed nationwide in the U.S.

    Product
    Cafe Favorites Cold Cut Combo on a Whole Grain Knot Roll Code #C02372/02372
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1903-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Sausage Bagel Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Turkey Sausage & Cheese Bagel Thin Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Turkey Sausage & Cheese Bagel Thin Sandwich Code #809013
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1914-2016·2016-08-17

    Let's Do Lunch Egg & Cheese Bagel Sandwich Recalled for Listeria

    Let's Do Lunch, Inc. is recalling Integrated Food Service Egg & Cheese Bagel Thin Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Egg & Cheese Bagel Thin Sandwich Code #C38004/380004
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1882-2016·2016-08-17

    Let's Do Lunch Recalls Oven Roasted Turkey Subs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Oven Roasted Turkey Breast Subs due to potential Listeria monocytogenes contamination.

    Product
    Cafe Favorites Oven Roasted Turkey Breast Sub Code #C02284/02284
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1889-2016·2016-08-17

    Let's Do Lunch Recalls Italian Submarine Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Italian Submarine Sandwiches due to potential Listeria monocytogenes contamination. The products were distributed nationwide.

    Product
    Integrated Food Service Italian Submarine Sandwich Code #C140004/C14004
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1877-2016·2016-08-17

    Let's Do Lunch Recalls Turkey Ham & Cheese Deli Flatz for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Turkey Ham & Cheese Deli Flatz due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Cafe Favorites Turkey Ham & Cheese Deli Flatz Code #C22148/22148
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2401-2016·2016-08-17

    Invacare Bariatric Bed Foot Section Recalled for Fire Hazard

    Invacare Corporation is recalling 3,050 Bariatric Bed Foot Sections because a junction box defect may cause sparks and fire.

    Product
    Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1921-2016·2016-08-17

    Raw Refrigerated Cucumbers Recalled Due to Salmonella Contamination

    Maglio & Co Ready Fresh is recalling raw refrigerated cucumbers because a sample tested positive for Salmonella spp.

    Product
    Raw Refrigerated Cucumbers, 11/9 bushel, 6 count, 12 count, 24 count, in corrugated cardboard cases, Southern Valley Produce Lot 16300705. (The product was either distributed in original container or were repackaged).
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2399-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Junction Box Fire Risk

    Invacare is recalling 2,184 Bariatric Beds because a defect in the Junction Box may cause sparks, posing a fire hazard in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2016·2016-08-17

    Integra External Fixation System Wire Fixation Bolts Recalled for Breakage

    Integra LifeSciences Corp. is recalling Universal Wire Fixation Bolts because the Slotted Post broke during use at the surgical site.

    Product
    Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·F-1898-2016·2016-08-17

    Let's Do Lunch Recalls Beef Burger Patties for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service All America Burger Beef Patties due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service All America Burger Beef Patty on a Whole Grain Bun Code #470007
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1906-2016·2016-08-17

    Let's Do Lunch Recalls Chili Cheese Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chili Cheese Dogs on Whole Grain Buns due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chili Cheese Dog on Whole Grain Buns Code #809022
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1896-2016·2016-08-17

    Let's Do Lunch Recalls Chicken Patty Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chicken Patty Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chicken Patty Sandwich Chicken Patty on a Whole Grain Bun Code #400003
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V605000·2016-08-17

    Road Rescue Emergency Vehicles Recalled for Electrical Short Circuit Risk

    REV is recalling 2010-2016 Road Rescue emergency vehicles due to power control modules that may cause short circuits, risking electrical damage, loss of headlights, or fire.

    Product
    ROAD RESCUE — ROAD RESCUE DURAMEDIC, ULTRAMEDIC, TRANSMEDIC, SPECIALTY VEHICLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1909-2016·2016-08-17

    Let's Do Lunch Recalls Chicken Hot Dog for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chicken Hot Dog on a Whole Grain Bun due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chicken Hot Dog on a Whole Grain Bun Code #941500
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2351-2016·2016-08-17

    Richard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination

    Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin due to potential potassium hydroxide contamination that may affect immunohistochemistry test results.

    Product
    Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle, 75 per case.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1455-2016·2016-08-17

    Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles

    Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.

    Product
    Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2402-2016·2016-08-17

    Invacare Bariatric Bed Junction Boxes Recalled for Fire Risk

    Invacare Corporation is recalling 1,011 Bariatric home care beds because the junction boxes may spark, posing a fire hazard in the presence of flammable materials.

    Product
    Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2400-2016·2016-08-17

    Invacare Bariatric Bed Recalled for Potential Fire Hazard from Junction Box Sparks

    Invacare is recalling 2,702 Bariatric Beds because the junction box may spark, posing a fire risk in the presence of flammable materials.

    Product
    Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1456-2016·2016-08-17

    Spectrum Chemical Recalls Zinc Acetate Due to Excess Lead Levels

    Spectrum Laboratory Products is recalling Zinc Acetate, Crystal, USP, because it contains lead levels exceeding USP monograph limits.

    Product
    Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2387-2016·2016-08-17

    Integra External Fixation System Slotted Post Recall for Breakage During Use

    Integra LifeSciences is recalling 111 units of External Fixation System Slotted Posts because they broke during use at the surgical site.

    Product
    Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·F-1907-2016·2016-08-17

    Let's Do Lunch Recalls Chicken Little Sliders for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chicken Little Sliders-Wrapped due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chicken Little Sliders-Wrapped Code #809050
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of 'Stapler Firing Failed' messages.

    Product
    STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2374-2016·2016-08-17

    Teleflex Servo Humidifier 163 Recalled Due to Connector Cracks

    Teleflex Medical is recalling Servo Humidifier 163 units because cracks may occur at the ISO female connectors.

    Product
    Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to war
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2016·2016-08-17

    Edan Diagnostics Recalls EtCO2 Modules for Incorrect CO2 Readings

    Edan Diagnostics is recalling 521 EtCO2 modules used in patient monitors because they may provide incorrect CO2 readings.

    Product
    EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60, iM8, iM8A, iM8B Patient Monitors and iM60 Vet, iM70 Vet Veterinary Monitors EtCO2 module is an optional component of the following machines: iM80, iM50, M50, iM70, iM60 and iM8, iM8A, iM8B, iM60 Vet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1919-2016·2016-08-17

    Williams Chipotle Taco Seasoning Recalled for Undeclared Wheat Allergen

    Williams Chipotle Taco Seasoning is being recalled because it contains undeclared wheat, a major allergen not listed on the label.

    Product
    Williams Chipotle Taco Seasoning, Net Wt. 1 1/4 OZ. (35.4 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2391-2016·2016-08-17

    Halyard Health Recalls Coolife Sinergy Radiofrequency Kits Due to Component Mismatch

    Halyard Health is recalling 51 Coolife Sinergy Radiofrequency Kits because the electrode length does not match the cannula length.

    Product
    Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2352-2016·2016-08-17

    Ortho VITROS Estradiol Reagent Recall Due to Fulvestrant Cross-Reactivity

    Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.

    Product
    VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16245·2016-08-17

    Xenith Recalls Football Helmets Due to Shell Cracking Hazard

    Xenith is recalling specific football helmets because the shells can crack, posing a risk of head injuries. No injuries have been reported.

    Product
    Football helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2016·2016-08-17

    Hill-Rom Recalls Volker Series Hospital Beds Due to Side Rail Defect

    Hill-Rom is recalling Volker 2080, 2082, S 280, and S 282 series hospital beds because the side rail latch may fail, causing the rail to lower and the patient to fall.

    Product
    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. A/C Powered Adjustable Hospital Bed Product Usage: Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1915-2016·2016-08-17

    Sundae Shoppe Ice Cream Cones Recalled for Undeclared Peanuts

    Mister Cookie Face is recalling Sundae Shoppe Novelty Ice Cream Dipped Variety cones because they may contain undeclared peanuts.

    Product
    Sundae Shoppe Novelty Ice Cream Dipped "Variety"cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed by Aldi, Batavia, IL 60510, UPC 041498191962
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2525-2016·2016-08-17

    Siemens Stratus CS STAT Fluorometric Analyzer Software Defect Recall

    Siemens is recalling Stratus CS STAT Fluorometric Analyzers due to a software defect that may cause inaccurate test results or out-of-range values when TestPaks are near expiration.

    Product
    Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1918-2016·2016-08-17

    Williams Chipotle Chili Seasoning Recalled for Undeclared Wheat Allergen

    CH Guenther & Sons, Inc. is recalling Williams Chipotle Chili Seasoning because it contains undeclared wheat, a major allergen not listed on the label.

    Product
    Williams Chipotle Chili Seasoning, Net Wt. 1 1/8 OZ. (32 g). Williams Foods, Inc. Lenexa, KS 66215. Packaged in paper pouches.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2379-2016·2016-08-17

    Merge PACS software recalled due to patient name mismatch

    Merge Healthcare is recalling PACS software versions V6.0.2.0 MR2 and earlier because patient names in the interface do not match the displayed images.

    Product
    Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1920-2016·2016-08-17

    Baptista's Bakery Recalls Snack Factory Pretzel Crisps for Undeclared Milk

    Baptista's Bakery is recalling Snack Factory Original Pretzel Crisps because they may contain undeclared milk. The product was distributed in eight US states and Canada.

    Product
    Snack Factory Original Pretzel Crisps, Thin, Crunchy Pretzel Crackers. Made in a facility that processes Milk and Soy. Distributed by: Snack Factory, PO Box 6917, Hanover, PA 17331 Sold in the following sizes and UPC codes: 12 ct / 116 oz. Net Wt 26 oz (l lb 10 o
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2385-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips Medical Systems is recalling 205 Ingenuity CT units due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2377-2016·2016-08-17

    Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues

    Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.

    Product
    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replace
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2016·2016-08-17

    Stryker Recalls Exeter Rasp Handle Due to Malfunctioning

    Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.

    Product
    Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2016·2016-08-17

    Ivoclar Vivadent Recalls OptraPol Dental Polishing Discs Due to Breakage

    Ivoclar Vivadent is recalling OptraPol polishing discs and cups because parts break away during use. The recall covers 86 units distributed in 16 states.

    Product
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalga
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-2347-2016·2016-08-17

    Philips MX 16-slice CT Systems Recalled for Software Defects

    Philips is recalling 80 MX 16-slice CT systems due to software bugs that may cause image mix-ups or scan interruptions.

    Product
    MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-1910-2016·2016-08-17

    Let's Do Lunch Recalls Chili Cheese Dog Products for Listeria Risk

    Let's Do Lunch, Inc. is recalling Integrated Food Service Chili Cheese Dog products due to potential Listeria monocytogenes contamination.

    Product
    Integrated Food Service Chili Cheese Dog Whole Grain Hot Dog Bun, Chicken Frank, Chili Sauce and Reduced Sodium Reduced Fat American Cheese Code #C95150/951500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1895-2016·2016-08-17

    Let's Do Lunch Recalls Italian Deli Flatz for Listeria Risk

    Let's Do Lunch, Inc. is recalling Cafe Favorites Italian Deli Flatz due to potential Listeria monocytogenes contamination. The product was distributed nationwide in the U.S.

    Product
    Cafe Favorites Italian Deli Flatz Code #C22548/22548
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2016·2016-08-17

    Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect

    Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.

    Product
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2353-2016·2016-08-17

    Stryker S3 MedSurg Bed Fowler Control Failure Recall

    Stryker is recalling S3 MedSurg Beds because CPU board failures can cause the backrest electronic controls to stop working.

    Product
    S3 MedSurg Bed, Model 3005. Stryker Medical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2016·2016-08-17

    Synthes 2.4mm Titanium Locking Screws Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling 41 units of 2.4mm Titanium Locking Screws because they can break between the head and shaft due to a thin wall design.

    Product
    Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone, Orthopedic Devices The 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm is a
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2398-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect

    Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2016·2016-08-17

    Merge PACS software recall for inconsistent mammography lesion measurements

    Merge Healthcare is recalling specific versions of Merge PACS software because lesion measurements differ between unmagnified and magnified mammography images.

    Product
    Merge PACS software. The firm name on the label is Merge Healthcare, Inc., 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
  • HighFDA (Devices)·Z-2348-2016·2016-08-17

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Firing Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 devices due to an increased trend of stapler firing failures.

    Product
    STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist¿ Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2397-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect

    Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.

    Product
    CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or cr
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2405-2016·2016-08-17

    Topcon Recalls PASCAL Synthesis Ophthalmic Laser Systems Due to Titration Anomaly

    Topcon Medical Laser Systems is recalling 205 PASCAL Synthesis ophthalmic laser systems worldwide due to a software anomaly affecting the titration process when specific functions are used.

    Product
    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1875-2016·2016-08-17

    Healthwise Protein Chips Recalled Due to Foreign Plastic Matter

    Nutritional Resources Inc. is recalling Healthwise Protein Chips because foreign plastic was observed in the product.

    Product
    Healthwise, Protein Chips, Barbecue Crunch, Net Weight 1.2 ounces (34 grams), Distributed by Nutritional Resources, Inc., Grovetown, GA 30813.
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2380-2016·2016-08-17

    Philips Brilliance 64 CT Scanner Software Recall

    Philips is recalling Brilliance 64 CT scanners due to software issues that could affect equipment performance.

    Product
    Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2365-2016·2016-08-17

    Invacare Pediatric Flowmeter Recalled Due to Upside-Down Rear Scale

    Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may confuse users.

    Product
    Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the pri
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2368-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 17 Brilliance BigBore CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Radiology Computed Tomography X-ray systems, 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-2375-2016·2016-08-17

    Nobel Biocare Recalls Guided Surgery Kit Instructions for Incorrect Drill Protocol

    Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.

    Product
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2016·2016-08-17

    Philips Brilliance BigBore CT Systems Recalled for Software Defect

    Philips is recalling eight Brilliance BigBore Oncology CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance BigBore Oncology Computed Tomography X-ray systems, 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-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-2392-2016·2016-08-17

    Hitachi Scenaria CT System Recalled for Power Supply Failure Risk

    Hitachi Medical Systems America is recalling 33 Scenaria CT systems because centrifugal force may cause the power supply to fail, potentially requiring patients to be rescanned.

    Product
    Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2366-2016·2016-08-17

    Philips Brilliance 64 CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 318 Brilliance 64 Computed Tomography X-ray systems due to a software defect causing intermittently slow response of the Host.

    Product
    Brilliance 64 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-2395-2016·2016-08-17

    Siemens Medical Solutions Recalls Artis Q and Q.Zen Angiography Systems

    Siemens Medical Solutions is recalling Artis Q and Q.Zen angiography systems because biomass in the cooling system may damage the pump.

    Product
    ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic x-ray system22 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 includi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2372-2016·2016-08-17

    Philips Ingenuity Core 128 CT Systems Recalled for Software Defect

    Philips is recalling five Ingenuity Core 128 CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core 128 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-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, pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2382-2016·2016-08-17

    Philips Brilliance iCT SP CT Scanner Software Recall

    Philips is recalling 57 Brilliance iCT SP CT scanners due to software issues in versions 4.1.3 and 4.1.5 that could affect equipment performance.

    Product
    Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2364-2016·2016-08-17

    Invacare Pediatric Flowmeter Recalled for Upside-Down Rear Scale Printing

    Invacare is recalling 395 Precise Rx Pediatric Flowmeters because the rear gradation scale was printed upside down, which may cause confusion during oxygen flow monitoring.

    Product
    lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2404-2016·2016-08-17

    Medline Medicine Cups Recalled for Incorrect Volume Markings

    Medline Industries is recalling 1-ounce medicine cups because the 10 mL increment is incorrectly printed as 5 mL, creating a risk of medication dosing errors.

    Product
    Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2383-2016·2016-08-17

    Philips CT Scanner Software Recall for Performance Issues

    Philips is recalling Ingenuity Core CT scanners due to software issues in versions v4.1.3, v4.1.4, and v4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2371-2016·2016-08-17

    Philips Ingenuity Core CT Systems Recalled for Software Defect

    Philips Medical Systems is recalling 29 Ingenuity Core CT systems due to a software defect causing intermittently slow response of the Host.

    Product
    Ingenuity Core 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-2384-2016·2016-08-17

    Philips Ingenuity CT Software Recall for Performance Issues

    Philips is recalling Ingenuity Core128 CT scanners due to software issues in versions 4.1.3, 4.1.4, and 4.1.5 that could affect equipment performance.

    Product
    Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-2394-2016·2016-08-17

    Siemens AXIOM Artis X-Ray Systems Recalled for Cooling System Contamination

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

    Product
    ARTIS ZEE AND ZEEGO, 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, pediatric and obese p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2344-2016·2016-08-17

    Siemens Artis Angiography Systems Recalled for Image Reproduction Failure

    Siemens Medical Solutions is recalling 51 Artis zee and Artis Q angiography systems due to a software error that may cause image loss after startup.

    Product
    Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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

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