The Recall Desk

Archive

May 2016 recalls

603 recalls were announced in May 2016.

What the numbers show

Critical
27
Severe
131
High
196
Moderate
208
Low
41

Of the 603 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

Which agencies issued them

101–200 of 603

  • ModerateFDA (Food)·F-1348-2016·2016-05-25

    Bunge Smart Source Creamy Soybean Frying Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 60 cases of Smart Source Creamy Soybean Frying Oil due to the presence of foreign material inside the jugs.

    Product
    Smart Source Creamy Soybean Frying Oil (Aceite de Soja Cremosa Para Freir), Net Wt./Peso Neto, 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13045 9
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1670-2016·2016-05-25

    Siemens ADVIA Chemistry Triglyceride Reagent Recalled for Linearity Defects

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Triglyceride reagent lots 348297 and 359932 because they fail linearity claims near end of shelf life.

    Product
    ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-1336-2016·2016-05-25

    Bunge Soy Clear Fry Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 3,240 cases of Bunge Soy Clear Fry Oil OU due to the presence of foreign material inside the jugs.

    Product
    Bunge Soy Clear Fry Oil OU, 35 lb., Manufactured by: Bunge Oils, Inc. Kearny, NJ 07032, UPC 00078684692026
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1340-2016·2016-05-25

    Bunge Harvest Value Canola Salad Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling Harvest Value Canola Salad Oil due to the presence of a foreign material inside the jugs.

    Product
    Harvest Value Canola Salad Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 02454 5
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1360-2016·2016-05-25

    Bunge Smart Source Canola Salad Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 60 cases of Smart Source Canola Salad Oil due to the presence of a foreign material inside the jugs.

    Product
    Smart Source Canola Salad Oil (Aceite de Canola Para Ensalada), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 17655 6
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1361-2016·2016-05-25

    Royal Snacks Jalapeno Pistachio Recalled for Undeclared Dyes

    Royal Snacks Inc is recalling Jalapeno Pistachio Royal Size products because they contain undeclared Yellow #5 and Blue #1 dyes.

    Product
    Royal Snacks Jalapeno Pistachio Royal Size
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1343-2016·2016-05-25

    Bunge Smart Source Soybean Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling 1,080 cases of Smart Source Clear Soybean Frying Oil due to the presence of a foreign material inside the jugs.

    Product
    Smart Source Clear Soybean Frying Oil (Aceite de Soya Transparente Para Freir), Net Wt./Peso Neto 35 lbs. (15.88 kg), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, UPC 0 08 22486 13046 6
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1362-2016·2016-05-25

    MegaFood Multi for Women 40+ Recalled for Missing Iron Warning

    FoodState, Inc. is recalling MegaFood Multi for Women 40+ multivitamin bottles because the labels lack the required iron warning statement and child-resistant cap.

    Product
    MegaFood Multi for Women 40+, Multivitamin & Mineral Dietary Supplement packaged in glass bottles UPC:5149410321 -Packaged 60 tablets; UPC:5149410322 -Packaged 120 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1342-2016·2016-05-25

    Bunge Vegetable Oil Recalled for Foreign Material Presence

    Bunge Oil North America Inc. is recalling Katy's Kitchen Soybean Salad Oil due to the presence of foreign material inside the jugs.

    Product
    Katy's Kitchen Soybean Salad Oil (Soya Aceite Para Ensalada), Marketed by/Comercializado por Independent Marketing Alliance, Houston, TX 77079, Product of USA/Producto de EE.UU., UPC 0 08 22486 13034 3
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1352-2016·2016-05-25

    Bunge Daily Chef Frying Oil Recalled for Foreign Material

    Bunge Oil North America Inc. is recalling specific lots of Daily Chef Food Service Pure Clear Frying Oil due to the presence of foreign material inside the jugs.

    Product
    Daily Chef Food Service Pure Clear Frying Oil (Aceite Transparente Para Freir), Net/Neto 4.5 Gal (17L) and Net Wt/Peso Neto, 35 lbs. (15.8 kg), Distributed By: Sam's West Inc., Bentonville, AR 72716, UPC 0 78742 06148 1
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-1338-2016·2016-05-25

    Bunge Canola Oil Recalled for Foreign Material Presence

    Bunge Oil North America Inc. is recalling Harvest Value Canola Liquid Frying Oil due to the presence of a foreign material inside the jugs.

    Product
    Harvest Value Canola Liquid Frying Oil, 35 lb., (15.88 kg), Distributed By: U.S. Foodservice, Inc,, Rosemont, IL 60018, UPC 5 07 58108 01988 6
    Category
    Food
    Distribution
    9 states
  • LowFDA (Food)·F-1333-2016·2016-05-25

    Manischewitz Pistachio Orange Macaroons Recalled for Pistachio Shell Fragments

    R.A.B. Food Group LLC is recalling Manischewitz Pistachio Orange Macaroons due to potential pistachio shell fragments.

    Product
    Manischewitz Pistachio Orange Macaroons 10 oz. Distributed by: The Manischewitz Company Newark, NJ 07105 Product of USA UPC 0-7270000119-6
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0856-2016·2016-05-25

    Allegiant Health Recalls Col-Rite Stool Softeners for Potency Issues

    Allegiant Health is recalling specific lots of Col-Rite stool softeners because they failed potency tests. Consumers should stop using the product and return it to the pharmacy.

    Product
    col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-count, item 351104, UPC 0 11822 51104 9; and b) 60-count, item 357392, UPC 0 11822 57392 4; DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL , PA 17011.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0854-2016·2016-05-25

    Hospira Recalls Magnesium Sulfate Injection Due to pH Failures

    Hospira Inc. is recalling 715,200 vials of Magnesium Sulfate Injection, USP 50% due to confirmed high out-of-specification pH results.

    Product
    Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalNHTSA·16V352000·2016-05-24

    Chrysler Recalls Vehicles Due to Passenger Air Bag Inflator Rupture Risk

    Chrysler is recalling approximately 4.6 million vehicles because passenger air bag inflators may rupture, sending metal fragments into the cabin. Owners are advised not to drive until repairs are complete.

    Product
    DODGE — DODGE, MITSUBISHI, JEEP DURANGO, RAM 3500, RAIDER, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V347000·2016-05-24

    Honda Recalls GL1800 Motorcycles Due to Air Bag Inflator Rupture Risk

    Honda is recalling 2006-2010 GL1800 motorcycles in specific regions because air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    HONDA — HONDA GL1800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V378000·2016-05-24

    Vermeer Recalls BC900XL Wood Chippers Due to Chassis Weld Defect

    Vermeer is recalling 2012-2016 BC900XL wood chippers because improper chassis welds could cause the unit to separate from the tow vehicle, increasing crash risk.

    Product
    VERMEER — VERMEER BC900XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V349000·2016-05-24

    Nissan Recalls Infiniti and Versa Vehicles for Air Bag Inflator Defect

    Nissan is recalling specific Infiniti and Nissan Versa vehicles because the passenger air bag inflators may rupture, potentially causing serious injury or death.

    Product
    INFINITI — INFINITI, NISSAN FX45, FX35, I35, M35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V348000·2016-05-24

    Hyundai Recalls 2016 Tucson Vehicles Due to Hood Latch Defect

    Hyundai is recalling 81,000 model year 2016 Tucson vehicles because the secondary hood latch may fail to secure the hood, increasing crash risk.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V342000·2016-05-24

    Mercedes-Benz Metris Recalled for Rear Differential Weld Defect

    Daimler Vans USA is recalling 2016 Mercedes-Benz Metris vans because improperly welded rear differential gears may fail, causing loss of power and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V346000·2016-05-24

    Honda Recalls Vehicles for Frontal Air Bag Inflator Rupture Risk

    Honda is recalling specific 2006-2011 models to replace passenger air bag inflators that may rupture during deployment, posing a risk of serious injury or death.

    Product
    HONDA — HONDA, ACURA CR-V, ACCORD, TSX, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V350000·2016-05-24

    Ford Vans Recalled for Wheelchair Lift Platform Cracking and Bearing Issues

    New England Wheels is recalling Ford E-250, E-350, and Transit vans equipped with specific Ricon wheelchair lifts. The platform side plates may crack or bearings may shift, causing the platform to fall and injure the operator.

    Product
    FORD — FORD E-250, E-350, TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16173·2016-05-24

    Rixson Exterior Gate Closers Recalled Due to Injury Hazard

    Rixson is recalling Exterior Gate Closers Model 1350 because the mechanism can break and eject metal pieces or spray oil, posing a risk of injury.

    Product
    Exterior Gate Closers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V351000·2016-05-24

    Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Missing Crash Pads

    Daimler Vans USA is recalling 2015-2016 Sprinter 2500 and 3500 vans with super-high roofs that may lack required crash pads, increasing injury risk for unbelted front passengers.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V334000·2016-05-23

    Mitsubishi Recalls Lancer Models Due to Air Bag Inflator Rupture Risk

    Mitsubishi is recalling 2006-2007 Lancer and Lancer Evolution vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    MITSUBISHI — MITSUBISHI LANCER, LANCER EVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V341000·2016-05-23

    Ferrari Recalls California and 458 Italia for Air Bag Inflator Rupture Risk

    Ferrari is recalling 2,826 California and 458 Italia vehicles because passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    FERRARI — FERRARI CALIFORNIA, 458 ITALIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V339000·2016-05-23

    Ducati Recalls 2014 1199 Superleggera Motorcycles for Clutch Defect

    Ducati is recalling 168 model year 2014 1199 Superleggera motorcycles because a clutch component could break, causing the engine to seize and the rear wheel to lock up.

    Product
    DUCATI — DUCATI 1199 SUPERLEGGERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V340000·2016-05-23

    Toyota Recalls Vehicles for Air Bag Inflator Rupture Risk

    Toyota is recalling specific 2006-2011 Scion, Toyota, Lexus, and Pontiac vehicles because the passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    SCION — SCION, TOYOTA, LEXUS XB, MATRIX, IS 250, GX460
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V344000·2016-05-23

    Honda Recalls Vehicles for Frontal Air Bag Inflator Rupture Risk

    Honda is recalling specific Acura and Honda models from 2002-2011 because the passenger frontal air bag inflators may rupture during deployment, potentially causing serious injury or death.

    Product
    ACURA — ACURA, HONDA RL, PILOT, ODYSSEY, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V338000·2016-05-23

    Stoughton Trailers Recall 2015-2017 Models Due to Brake Valve Defect

    Stoughton Trailers is recalling 2,657 model year 2015-2017 trailers because improperly machined spring brake valves may cause the parking brake to fail.

    Product
    STOUGHTON — STOUGHTON ZGPVW, AVW, DVW, AVXW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V335000·2016-05-23

    Mercedes-Benz Recalls 2016 AMG CLA45 for Dual Clutch Weld Defect

    Mercedes-Benz is recalling one 2016 AMG CLA45 vehicle because a defective weld in the dual clutch transmission may crack, causing a sudden loss of power to the wheels.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG CLA45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V333000·2016-05-23

    BMW Recalls X3 and X4 Models for Child Seat Anchor Defect

    BMW is recalling specific X3 and X4 models because lower anchor bars for child seats may be damaged, increasing injury risk in a crash.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E048000·2016-05-23

    Tucker Rocky Recalls Speed and Strength SS2200 Motorcycle Helmets

    Tucker Rocky is recalling Speed and Strength SS2200 motorcycle helmets that failed federal penetration testing. Owners should contact the company to receive a free replacement.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2016·2016-05-20

    Papa John's Salads Recalls Chicken Salads Due to Listeria Risk

    Papa John's Salads is recalling ready-to-eat chicken salads due to possible Listeria contamination from sunflower kernels. No illnesses have been reported.

    Product
    Taylor Farms Southwest Inc. — Papa John's Salads and Produce Recalls Ready-To-Eat Salad with Chicken Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·16V330000·2016-05-20

    Forest River Charleston Motorhomes Recalled for Brake Signal Defect

    Forest River is recalling 2014-2016 Charleston motorhomes because a brake signal may remain active, causing towed device brakes to overheat and potentially catch fire.

    Product
    FOREST RIVER — FOREST RIVER CHARLESTON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16745·2016-05-20

    Bestar Recalls Juvenile Dressers Due to Tip-Over Hazard

    Bestar is recalling juvenile dressers sold in the US and Canada because they are unstable and pose a tip-over hazard to children.

    Product
    Juvenile dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V329000·2016-05-20

    Thor Motor Coach Recalls 2017 Motorhomes for Electrical Defect

    Thor Motor Coach is recalling 2017 Tuscany and Venetian motorhomes because an improperly installed cable could cause sudden power loss, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY ZTE, VENETIAN, TUSCANY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V332000·2016-05-20

    Heartland Recalls 2017 Trailers With Incorrect Tire Pressure Labels

    Heartland is recalling 618 model year 2017 Wilderness, North Trail, and Mallard trailers because certification labels contain incorrect tire pressure information.

    Product
    HEARTLAND — HEARTLAND WILDERNESS, NORTH TRAIL, MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V331000·2016-05-20

    Ford Transit wheelchair lift platform defect recall

    National Van Builders is recalling 2015 Ford Transit vans with specific Ricon wheelchair lifts due to potential platform cracking or bearing displacement that could cause injury.

    Product
    FORD — FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V322000·2016-05-19

    Keystone Summerland Recalled for Incorrect Tire Load Rating

    Keystone is recalling 2016-2017 Summerland trailers manufactured in April 2016 because they may have incorrect tire load ratings, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE SUMMERLAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16169·2016-05-19

    Black Diamond Recalls Via Ferrata Climbing Sets Due to Fall Hazard

    Black Diamond is recalling about 100 via ferrata climbing sets because missing safety stitching may allow lanyard ends to detach, posing a risk of injury or death.

    Product
    Black Diamond via ferrata climbing sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V324000·2016-05-19

    Daimler Recalls 2014-2017 Thomas Built Buses Saf-T-Liner HDX for Coolant Leak Risk

    Daimler Trucks is recalling 131 Thomas Built Buses Saf-T-Liner HDX vehicles due to a rubber elbow that may restrict coolant flow and fail, potentially leaking hot coolant inside the bus.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V328000·2016-05-19

    Ameritrans 285 Shuttle Buses Recalled for Inaccurate Weight Rating Labels

    Ameritrans is recalling 2012-2016 285 shuttle buses because certification labels may list an inaccurate gross vehicle weight rating, potentially affecting vehicle handling.

    Product
    AMERITRANS — AMERITRANS 285
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V326000·2016-05-19

    Thomas Built Buses Recalling Saf-T-Liner HDX Buses for Hose Failure Risk

    Daimler Trucks is recalling 2011-2017 Thomas Built Buses Saf-T-Liner HDX vehicles because a transmission issue may cause heater hoses to fail, leaking hot coolant inside the bus.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V325000·2016-05-19

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Hose Failure

    Daimler Trucks North America is recalling 2011-2017 Thomas Built Buses Saf-T-Liner HDX school buses because a transmission retarder may cause heater hose failure, leading to hot coolant leaks.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·042-2016·2016-05-19

    Conagra Recalls Two Beef Products Due To Undeclared Fish Allergen

    Conagra Foods is recalling two frozen beef products because they may contain undeclared fish (anchovies) from Worcestershire sauce.

    Product
    ConAgra Brands, Inc. — Conagra Foods Packaged Foods, LLC Recalls Two Beef Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V323000·2016-05-19

    Thomas Built Buses Recalls Saf-T-Liner HDX School Buses for Coolant Leak Risk

    Daimler Trucks North America is recalling 2014-2017 Thomas Built Buses Saf-T-Liner HDX school buses because a rubber coolant elbow may fail, leaking hot coolant inside the bus.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16164·2016-05-19

    Black Diamond Recalls Index Climbing Ascenders Due to Fall Hazard

    Black Diamond is recalling Index Ascenders because a rivet may release, causing the device to detach from the rope and posing a risk of injury or death.

    Product
    Black Diamond Index Ascenders for climbing
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16168·2016-05-19

    Black Diamond Recalls Camalot Climbing Devices Due to Fall Hazard

    Black Diamond is recalling approximately 45,500 Camalot and Camalot Ultralight climbing devices because they can come apart during use, posing a fall hazard.

    Product
    Black Diamond Camalot climbing devices
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1044-2016·2016-05-18

    Meijer Frozen Butternut Squash Ravioli Recalled for Undeclared Cashew and Almond

    Bertagni 1882 is recalling Meijer frozen Butternut Squash Ravioli because the product may contain undeclared cashew and almond.

    Product
    Meijer frozen Butternut Squash Ravioli, product is packaged in a paper box, net weight 12 oz., UPC 760236398479
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-1327-2016·2016-05-18

    Garden of Life Raw Meal Organic Vanilla Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Vanilla Powder products due to possible Salmonella contamination. The recall covers multiple lot codes distributed nationwide and internationally.

    Product
    Raw Meal Organic Vanilla Powder; Organic Shake and Meal Replacement; 949 g, 475 g, and 10-ct tray (68 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1328-2016·2016-05-18

    Garden of Life Organic Chocolate Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Chocolate Powder products due to possible Salmonella contamination. The recall covers 422,923 units distributed nationwide and internationally.

    Product
    Raw Meal Organic Chocolate Powder; Organic Shake and Meal Replacement; 986 g, 493 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1329-2016·2016-05-18

    Garden of Life Raw Meal Organic Powder Recalled for Salmonella Risk

    Garden of Life is recalling Raw Meal Organic Original Powder products due to possible Salmonella contamination. The recall affects 422,923 units distributed nationwide and internationally.

    Product
    Raw Meal Organic Original Powder; Organic Shake and Meal Replacement; 908 g, 454 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1330-2016·2016-05-18

    Garden of Life Raw Meal Organic Vanilla Spiced Chai Powder Recalled for Salmonella

    Garden of Life is recalling Raw Meal Organic Vanilla Spiced Chai Powder due to possible Salmonella contamination. The product was distributed nationwide and in several international markets.

    Product
    Raw Meal Organic Vanilla Spiced Chai Powder; Organic Shake and Meal Replacement; 909 g, 455 g, and 10-ct tray (65 g each). Packaged in plastic bottle with colored label.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1646-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Susceptibility Test Cards Recalled for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1637-2016·2016-05-18

    Bradshaw Medical Recalls Axial Torque Limiting Drivers Due to Component Failure

    Bradshaw Medical Inc. is recalling 3,760 Axial Torque Limiting Drivers because a component failure could cause applied torque to exceed the calibrated setting.

    Product
    Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instrument designed to limit the magnitude of applied (input) torque transferred to an external (output) device or fastener in the clockwise…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2016·2016-05-18

    Biomerieux Vitek 2 Gram Positive Test Cards Recalled for Labeling Error

    Biomerieux is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1645-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1632-2016·2016-05-18

    St. Jude Medical Recalls Ellipse ICD Devices for Therapy Failure Risk

    St. Jude Medical is recalling 127 Ellipse ICD devices because they may fail to deliver high-voltage therapy needed to treat life-threatening heart rhythms.

    Product
    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V316000·2016-05-18

    Autocar Recalls 2016-2017 Xpeditor Vehicles Due to Rear Axle Defect

    Autocar is recalling 67 Xpeditor vehicles because improperly bent tab lock washers may allow rear axle spindle nuts to loosen, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1326-2016·2016-05-18

    Granna's 808 French Toast Recalled for Whey Mislabeling

    Granna's LLC is recalling 808 French Toast, Diced Potatoes, and Mandarin Oranges because the label lists whey instead of milk.

    Product
    Granna's 808 French Toast, Diced Potatoes, Mandarin Oranges in three compartment black, plastic tray, stored frozen
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1644-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1634-2016·2016-05-18

    Stryker Recalls CinchLock SS Knotless Anchor Due to Wire Breakage

    Stryker is recalling CinchLock SS Knotless Anchors after reports of internal wire breakage upon deployment.

    Product
    CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·16V319000·2016-05-18

    Autocar Recalls 2016-2017 Xpert and Xspotter Trucks for Rear Axle Defect

    Autocar is recalling 43 model year 2016-2017 Xpert and Xspotter trucks because improperly bent tab lock washers may allow rear axle spindle nuts to loosen, potentially causing the wheel assembly to separate.

    Product
    AUTOCAR — AUTOCAR XPERT, XSPOTTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1640-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1648-2016·2016-05-18

    Medtronic Recalls Kangaroo Connect Enteral Feeding Pumps Due to Alarm Failure

    Medtronic is recalling 223 Kangaroo Connect Enteral Feeding Pumps because occlusion alarms may fail to sound, potentially leading to unsafe feeding conditions.

    Product
    Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1642-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1043-2016·2016-05-18

    Bertagni Fresh Sweet Butternut Squash Ravioli Recalled for Undeclared Nuts

    Bertagni 1882 is recalling fresh Sweet Butternut Squash Ravioli because the product may contain undeclared cashew and almond.

    Product
    Bertagni fresh Sweet Butternut Squash Ravioli, packaged in a paper tray inside a plastic bag and wrapped around with paper band, net weight 8.8 oz., UPC 8001020110139.
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1616-2016·2016-05-18

    Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk

    Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.

    Product
    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1666-2016·2016-05-18

    Siemens Uric Acid Assays Recalled Due to Drug Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Uric Acid assays because NAC and Metamizole can cause falsely depressed results.

    Product
    Dimension Vista Assays: Uric Acid (URCA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1577-2016·2016-05-18

    Medtronic Recalls Capnostream 20 Patient Monitor Battery Packs

    Medtronic is voluntarily recalling battery packs for the Capnostream 20 and 20p patient monitors because they may experience thermal runaway, posing a potential fire risk.

    Product
    Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V318000·2016-05-18

    Heartland Recalls 2016-2017 Trailers Due to Safety Chain Failure Risk

    Heartland is recalling 2016-2017 Fair Field, Lakeview, and Resort trailers because safety chains may break if the main connection fails, increasing crash risk.

    Product
    HEARTLAND — HEARTLAND FAIR FIELD, LAKEVIEW, RESORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1639-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards for Labeling Error

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1647-2016·2016-05-18

    Biomerieux Recalls Vitek 2 Gram Positive Susceptibility Test Cards

    Biomerieux Inc is recalling Vitek 2 Gram Positive Susceptibility Test Cards because the product insert fails to identify a performance limitation related to EUCAST breakpoints for Teicoplanin.

    Product
    Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit. Product Usage: The VITEK 2 Gram Positive Susceptibility Card is intended for use with VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1635-2016·2016-05-18

    Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage

    Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.

    Product
    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1325-2016·2016-05-18

    CVS Gold Emblem Organic Spiced Herbal Tea Recalled for Salmonella

    CVS Health is recalling Gold Emblem Abound Organic Spiced Herbal Tea because the product contains Salmonella. Consumers should stop using the product.

    Product
    Gold Emblem Abound Organic Spiced Herbal Tea, 20 TEA BAGS, NET WT 1.41 OZ (40g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2016·2016-05-18

    Hamilton G5 Ventilator Recalled for Suctioning Maneuver Software Defect

    Hamilton Medical is recalling 1,115 Hamilton G5 ventilators because the ventilation pattern may not continue as expected after a suctioning maneuver.

    Product
    Hamilton G5 with software version between v2.41, v2.42, v2.50. Catalog number: 1590001 and 1590002. Anesthesiology: Hamilton G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infants and neonatal patients. The device is…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·16V315000·2016-05-18

    Lakota Luxe Trailers Recalled for Microwave Fire Risk

    Lakota is recalling 2014 Luxe trailers because the built-in microwave may start on its own, posing a fire hazard.

    Product
    LAKOTA — LAKOTA LUXE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2016·2016-05-18

    C.R. Bard Recalls Arctic Sun Temperature Management Systems

    C.R. Bard is recalling 2,613 Arctic Sun Temperature Management Systems because electronic components may cause the internal battery to drain prematurely, rendering the device unresponsive.

    Product
    Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring and controlling patient temperature
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1613-2016·2016-05-18

    Novarad NovaPACS Diagnostic Viewer Recalled for Incorrect SUV Calculations

    Novarad Corporation is recalling specific versions of NovaPACS Diagnostic Viewer because the PET/CT fusion tool calculates incorrect SUV values.

    Product
    NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2016·2016-05-18

    Recall of Given Imaging Bravo pH Capsule Delivery Devices

    Covidien LLC is recalling Bravo pH capsule delivery devices due to a potential risk of allergic reactions in patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿ pH capsule delivery device, 5-pack. In-Vitro Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0312 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16163·2016-05-18

    phil&teds Recalls Dash Strollers Due to Hinge Pinch Hazard

    phil&teds is recalling about 630 Dash v5 strollers in the U.S. because the folding hinge can become damaged, posing a pinch hazard to consumers.

    Product
    phil&teds dash strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2016·2016-05-18

    FDA Recalls Given Imaging Bravo pH Capsule Delivery Device

    FDA is recalling the Given Imaging Bravo pH capsule delivery device due to a potential allergic reaction risk for patients with nickel sensitivity.

    Product
    Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1623-2016·2016-05-18

    Stanmore Distal Femoral Replacement Recalled for Incorrect Component

    Stanmore Implants Worldwide Ltd. is recalling one custom-made distal femoral replacement implant due to the use of an incorrect component during manufacturing.

    Product
    Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
    Category
    Medical Device
    Distribution
    1 state

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