The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
99
Severe
150
High
458
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 18% are Severe.

Which agencies issued them

201–300 of 850

  • ModerateFDA (Devices)·Z-1837-2017·2017-04-26

    Alcon Recalls Patient Care Kits Due to Sterile Packaging Concerns

    Alcon is voluntarily removing 561,702 Patient Care Kits from the US market because the supplier reported potential sterile packaging compromise.

    Product
    Alcon Patient Care Kits Product Usage: A Patient Care Kit is an assemblage of single-use medical devices and accessories designed by medical professionals for specific procedures. The Patient Care kits are configured with customer-specific components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2017·2017-04-26

    Merge Healthcare Recalls Eye Station and Eye Care PACS Software

    Merge Healthcare is recalling Eye Station and Eye Care PACS software because antivirus programs may permanently delete newly captured medical images.

    Product
    Merge Eye Station and Merge Eye Care PACS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1835-2017·2017-04-26

    Ace Surgical Supply Recalls Incorrectly Packaged Dental Abutments

    Ace Surgical Supply Co., Inc. is recalling 87 INFINITY Internal Hex Healing Abutments because the incorrect device was packaged.

    Product
    INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2017·2017-04-26

    Siemens Artis zee Angiographic X-ray System Software Recall

    Siemens is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.

    Product
    Artis zee, Angiographic x-ray system
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1827-2017·2017-04-26

    Ferno Chair Cot Recalled Due to Incorrect Manufacturing Nut

    Ferno-Washington Inc is recalling 34 units of the PROFlexx Model 28Z Chair Cot because an incorrect nut was used during manufacturing.

    Product
    Ferno PROFlexx¿ Model 28Z Chair Cot
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1865-2017·2017-04-26

    Avid Medical Recalls Vacutainer Tubes Due to Mixed Component Lots

    Avid Medical is recalling 25,308 Vacutainer tubes because an expired component was found in a kit with a later expiration date, leading to incorrect lot and expiration labeling.

    Product
    Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2084-2017·2017-04-26

    Sun Opta Recalls Organic Roasted Soy Bits Due to Plastic Contamination

    Sun Opta is recalling specific lots of organic roasted soy bits and splits because pieces of plastic were found in the product.

    Product
    Soy Bits and Soy Splits, Organic, Roasted Not Salted, Individual Super Sac (1450 pounds Soy Bits and 1400 - 1600 pound Soy Splits)
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1856-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Orthopedic Screws Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 100 units of D-RAD orthopedic screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2017·2017-04-26

    Neodent CM Intraoral Scanbody Recalled for Incompatibility with CM Implants

    Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.

    Product
    NEODENT CM Intraoral Scanbody, Article Number: 108.139
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1855-2017·2017-04-26

    Smith & Nephew Recalls D-RAD Locking Pegs Due to Incorrect Expiration Dates

    Smith & Nephew is recalling 19 units of D-RAD locking pegs because the expiration dates on the labels are incorrect and later than the actual dates.

    Product
    D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0672-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Pore Therapy Salicylic Acid Acne Treatment

    Valeant Pharmaceuticals is voluntarily recalling CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment due to discoloration.

    Product
    CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0675-2017·2017-04-26

    InnovaGel Recalls Subpotent Dye Free Allergy Softgel Gelatin Capsules

    InnovaGel is voluntarily recalling Dye Free Allergy Softgel Gelatin Capsules because they are subpotent. The affected product was distributed in New York.

    Product
    Dye Free Allergy Softgel Gelatin Capsule, 15,000-count bulk drums, aenova/Swiss Caps USA, Inc., 14193 S.W. 119th Avenue, Miami, FL 33186, Product Code MSU0067P, NDC 6897080284
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0673-2017·2017-04-26

    Valeant Recalls CLENZIderm M.D. Acne Treatment Kits Due to Discoloration

    Valeant Pharmaceuticals is voluntarily recalling 5,647 units of CLENZIderm M.D. Acne Treatment Systems nationwide due to product discoloration.

    Product
    CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals No
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·039-2017·2017-04-25

    Fineberg Packing Recalls Ready-to-Eat Ham Products Due to Listeria Risk

    Fineberg Packing Co. is recalling approximately 8,822 pounds of ready-to-eat ham products in Arkansas, Mississippi, and Tennessee due to possible Listeria monocytogenes contamination.

    Product
    Fineberg Packing Co., Inc. Recalls Ready-To-Eat Ham Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·17V273000·2017-04-25

    Ram ProMaster Recall for Incorrect Air Bag Labeling

    Chrysler is recalling 2014-2017 Ram ProMaster vehicles because labels incorrectly state they have frontal air bags. This mislabeling may increase injury risk in a crash.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17138·2017-04-25

    Zutano Recalls Infant Cozie Booties Due to Choking Hazard

    Zutano is recalling about 38,000 infant Cozie booties because the rubber grips on the bottom can detach and pose a choking hazard.

    Product
    Infant Cozie booties
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17139·2017-04-25

    Horizon Hobby Recalls Remote-Controlled Model Vehicles Due to Fire Hazard

    Horizon Hobby is recalling specific ECX model vehicles because the electronic speed control can short circuit and catch fire. No injuries or property damage have been reported.

    Product
    ECX Circuit, Ruckus, and Torment remote-controlled model vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·037-2017·2017-04-24

    WFSP Foods Recalls Undercooked Ready-to-Eat Chicken Breast Products

    WFSP Foods LLC is recalling approximately 42,147 pounds of ready-to-eat chicken breast products that may be undercooked, posing a risk of bacterial pathogens.

    Product
    WFSP Foods LLC — WFSP Foods LLC. Recalls Ready-To-Eat Chicken Breast Products That May Be Undercooked
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·038-2017·2017-04-24

    Uncle John's Pride Recalls Sausage Products Due to Foreign Matter Contamination

    Uncle John's Pride LLC is recalling approximately 139,909 pounds of ready-to-eat smoked sausage products due to possible contamination with extraneous materials, including a metal magnet.

    Product
    Uncle John's Pride LLC — Uncle John's Pride, LLC. Recalls Ready-To-Eat Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereUSDA FSIS·036-2017·2017-04-22

    Campbell Recalls Chicken Soup Cans Due to Undeclared Milk Allergen

    Campbell Soup Company is recalling specific cans of chicken soup because they contain undeclared milk, a known allergen.

    Product
    Campbell Soup Company — Campbell Soup Company Recalls Chicken Soup Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V267000·2017-04-21

    GM Recalls 2017 Buick LaCrosse for Rear Suspension Toe-Link Defect

    General Motors is recalling 2017 Buick LaCrosse vehicles because incorrectly installed rear suspension toe-links may loosen and disconnect, potentially causing a loss of vehicle control.

    Product
    BUICK — BUICK LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V272000·2017-04-21

    Daimler Recalls 2013-2016 Sprinter and Metris Vehicles for Software Conflict

    Daimler Vans USA is recalling 2013-2014 Freightliner Sprinter and 2016 Mercedes-Benz Metris vehicles because software updates may conflict with vehicle computers, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, METRIS, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V269000·2017-04-21

    Ford E-450 Propane Conversion Kit Recall for Engine Stall Risk

    National Fleet Services of Ohio is recalling 2016 Ford E-450 vehicles with Roush propane kits because a faulty solenoid may cause the engine to shut off while driving.

    Product
    FORD — FORD E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V270000·2017-04-21

    Riverside RV Recalls 2017-2018 Trailers for Missing Rear Reflectors

    Riverside RV is recalling 2017-2018 Mt. McKinley and Whitewater travel trailers because they lack required rear-facing reflectors and reflective tail lights, increasing crash risk.

    Product
    RIVERSIDE — RIVERSIDE MT. MCKINLEY, WHITEWATER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V265000·2017-04-20

    GM Recalls 2014-2016 Chevrolet Caprice Police Pursuit for Steering Defect

    General Motors is recalling 2014-2016 Chevrolet Caprice Police Pursuit vehicles because a steering connector may fail, causing loss of power steering assist and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET CAPRICE POLICE PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V264000·2017-04-20

    Thor Motor Coach Recalls 2017 Quantum Motorhomes Due to Fire Risk

    Thor Motor Coach is recalling 2017 Quantum KM24 motorhomes because an incorrectly attached power wire may prevent a circuit breaker from tripping, increasing fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH QUANTUM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·035-2017·2017-04-20

    Request Foods Recalls Chicken Burritos Due to Undeclared Allergens

    Request Foods is recalling approximately 30,537 pounds of frozen chicken burritos because they contain undeclared egg and soy allergens.

    Product
    Request Foods Inc. — Request Foods, Inc. Recalls Chicken With Cheese Burrito Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-042017·2017-04-20

    Conagra Recalls Chicken Nuggets Meal Trays Due to Salmonella Risk

    Conagra Brands is recalling 110,817 pounds of frozen chicken nugget meal trays because the included brownie mix may be contaminated with Salmonella.

    Product
    FSIS Issues Public Health Alert For Chicken Nuggets Meal Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1958-2017·2017-04-19

    Dolcetta White Chocolate Coconut Snowman Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling White Chocolate Coconut Snowman products due to undeclared soy lecithin and milk allergens.

    Product
    White Chocolate Coconut Snowman. White chocolate with coconut shaped like a snowman, net wt. 45g (1.6 oz). Product packaged in clear plastic bag with a twist tie closure. The label declared "***White Chocolate Coconut Snowman***34% white chocolate, coconut, coconut milk powd
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1913-2017·2017-04-19

    Pro Sports Club Recalls Yogurt Peanut Crunch Bars Due to E. coli Risk

    Pro Sports Club is recalling 20/20 LifeStyles Yogurt Peanut Crunch Bars due to potential E. coli O157:H7 contamination. The product was distributed in Washington and sold online.

    Product
    20/20 LifeStyles Yogurt Peanut Crunch Bar. Bar UPC 7 8571 00052. Each bar has net weight 2 oz. Box UPC 7 8571 00053. Each box has 12/2 oz. bars. Case UPC 78571 00054. Each case has 12 boxes and it is for shipment only and not for resale.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1868-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Ouleout soft wash-rind raw milk cheese due to possible contamination with Listeria monocytogenes.

    Product
    Vulto Creamery Ouleout soft wash-rind raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1870-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Andes Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Andes raw milk cheese due to possible Listeria monocytogenes contamination. The product was sold in five northeastern states.

    Product
    Vulto Creamery Andes raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1869-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Miranda soft wash-rind raw milk cheese due to possible contamination with Listeria monocytogenes.

    Product
    Vulto Creamery Miranda soft wash-rind raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1871-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Hamden raw milk cheese due to possible contamination with Listeria monocytogenes.

    Product
    Vulto Creamery Hamden raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1948-2017·2017-04-19

    Dolcetta White Chocolate Almond Bars Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling White Chocolate Sweet & Salty Almond Bars due to undeclared soy lecithin and milk.

    Product
    White Chocolate Sweet & Salty Almond Bar is also called Salty Almond Bar. It is white chocolate almond with sea salt, 1.2 oz (33g), product is wrapped in metal foil and then wrapped in paper box. The ingredients statements declared: 32% caramelized white chocolate, almonds,
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1773-2017·2017-04-19

    Draegar Delta XL Patient Monitors Recalled for Low Oxygen Alarm Failure

    Draegar Medical Systems is recalling Delta XL patient monitors because the low oxygen alarm may fail to sound when oxygen levels drop below the limit.

    Product
    Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Product Usage: The devices are intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1761-2017·2017-04-19

    PerkinElmer Recalls Specimen Gate Laboratory Software Due to Data Errors

    PerkinElmer is recalling 29 units of Specimen Gate Laboratory software due to a potential for errors in patient results. The software is used for processing laboratory data.

    Product
    Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data.
    Category
    Medical Device
    Distribution
    23 states
  • SevereFDA (Food)·F-1901-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling I.M. Healthy Creamy SoyNut Butter nationwide due to potential E. coli O157 contamination.

    Product
    I.M. Healthy, Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1865-2017·2017-04-19

    Tomales Bay Foods Recalls Miranda Cheese Due to Listeria Risk

    Tomales Bay Foods is recalling specific lots of Miranda cheese because the supplier reported potential Listeria monocytogenes contamination.

    Product
    Miranda, 5 lb. wrapped in paper; Vulto Creamery, Walton, NY.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1866-2017·2017-04-19

    Tomales Bay Foods Recalls Hamden Cheese for Listeria Risk

    Tomales Bay Foods is recalling 3.5 lb. Hamden cheese from Vulto Creamery due to potential Listeria monocytogenes contamination.

    Product
    Hamden, 3.5 lbs. wrapped in paper Vulto Creamery, Walton, NY.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1886-2017·2017-04-19

    Lake Fresh Smoked Tilapia Recalled for Un-Removed Internal Organs

    Capital Street LLC is recalling Lake Fresh Whole Smoked Tilapia because New York State sampling found the fish was not eviscerated.

    Product
    Lake Fresh Whole Smoked Tilapia Net Wt 8 oz Capital Street LLC Old Bridge, NJ 08857 UPC 0680296079
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0664-2017·2017-04-19

    Medisca Recalls Estrone USP Bulk Due to cGMP Deviations

    Medisca, Inc. is recalling Estrone, USP Bulk in various bottle sizes due to current Good Manufacturing Practice (cGMP) deviations identified during an FDA inspection.

    Product
    ESTRONE, USP Bulk, in a) 100 mgs (NDC 38779-0891-05), b) 1 gram (NDC 38779-0891-06), c) 5 grams (NDC 38779-0891-03), d) 25 grams (NDC 38779-0891-04), and e) 100 grams (NDC 38779-0891-09) Bottles, Packed by MEDISCA INC. PLATTSBURGH, NY 12901; Product Code 0891
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0659-2017·2017-04-19

    FDA Recalls Ethinyl Estradiol Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling bulk Ethinyl Estradiol Micronized manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Food)·F-1872-2017·2017-04-19

    Whole Foods Recalls Vulto Creamery Raw Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Vulto Creamery Walton Umber raw milk cheese due to possible contamination with Listeria monocytogenes.

    Product
    Vulto Creamery Walton Umber raw milk cheese cut and wrapped in clear plastic
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-1947-2017·2017-04-19

    Dolcetta S'more Bars Recalled for Undeclared Soy and Milk Allergens

    Dolcetta Artisan Sweets is recalling 50 S'more Bars in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    S'more Bar contains dark chocolate and toasted white chocolate with graham cracker, 1.2 oz (33g), Product wrapped in metal foil and then wrapped in paper box. The label declared "***SMores Bar *** 60% dark chocolate, 32% white chocolate, graham crackers (wheat), vanilla bean *
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1702-2017·2017-04-19

    Medtronic StrataMR Valves Recalled for Incorrect Rotor Orientation

    Medtronic is recalling StrataMR valves and shunts because incorrect rotor orientation can cause underdrainage of cerebrospinal fluid, potentially leading to serious health consequences.

    Product
    The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressu
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·17V263000·2017-04-19

    Gillig Recalls 2015-2016 Low Floor Buses for Suspension Defect

    Gillig is recalling 2,604 Low Floor transit buses because improperly seated snap rings in the suspension kneeling modules may cause a loss of air pressure, increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1916-2017·2017-04-19

    J & J Distributing Recalls Shredded Carrots Contaminated with Metal Pieces

    J & J Distributing Company is recalling shredded carrots contaminated with metal pieces. The carrots were used as an ingredient in ready-to-eat items distributed in Minnesota and Wisconsin.

    Product
    Mix General Tso Chik, 2 lbs Food service plastic bag for Food Service (Supervalu & Franchise). Chinese Chicken Salad, 2.65 lbs for Food Service (Franchise) in Food service plastic bag.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1776-2017·2017-04-19

    Volcano Recalls Refinity Short Tip Rotational IVUS Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Short Tip Rotational IVUS Catheters due to high complaint rates of kinking near the proximal shaft junction, which may disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examina
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1867-2017·2017-04-19

    Tomales Bay Foods Recalls Ouleout for Listeria Contamination Risk

    Tomales Bay Foods is recalling 1.5 lb. paper-wrapped Ouleout from Vulto Creamery due to potential Listeria monocytogenes contamination.

    Product
    Ouleout, 1.5 lbs. wrapped in paper Vulto Creamery, Walton, NY.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1915-2017·2017-04-19

    J & J Distributing Recalls Cranberry Walnut Salad Due to Metal Contamination

    J & J Distributing Company is recalling specific Cub Foods and Kowalski's Markets Cranberry Walnut Salad products because shredded carrot ingredients were contaminated with metal pieces.

    Product
    Cub Foods (Fresh), Cranberry Walnut Salad, UPC 0-41144-37302-5, 20 0z. Plastic deli container. Kowalski's Markets, Salad Greens, Cranberry Walnut Salad, UPC 6-10014-14320-6, 9 oz. Plastic container.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1777-2017·2017-04-19

    Welch Allyn ProBP 2400 Digital Blood Pressure Device Recall

    Welch Allyn is recalling 981 ProBP 2400 digital blood pressure devices due to a defective electrical component that may cause over-voltage battery charging and melting of plastic parts.

    Product
    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Micro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1925-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Black and Tan Bar for Undeclared Allergens

    Dolcetta Artisan Sweets is recalling 50 bars of Black and Tan Bar in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    Black and Tan Bar contains dark chocolate and white chocolate with cocoa nibs, 1.2 oz (33g), Product wrapped in metal foil and then wrapped in a paper box.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V260000·2017-04-19

    Tesla Recalls Model S and X for Parking Brake Gear Defect

    Tesla is recalling 2016 Model S and 2016-2017 Model X vehicles because a parking brake gear may fracture, potentially causing the vehicle to roll or become immobile.

    Product
    TESLA — TESLA MODEL S, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0658-2017·2017-04-19

    FDA Recalls Testosterone Micronized Bulk Due to cGMP Deviations

    Qinhuangdao Zizhu Pharmaceutical is recalling Testosterone Micronized Bulk due to cGMP deviations and lack of quality assurance. The product was distributed to six states.

    Product
    Testosterone Micronized, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-006-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0657-2017·2017-04-19

    FDA Recalls Estrone Micronized Bulk Drug Due to Quality Assurance Failures

    The FDA is recalling Estrone Micronized bulk drug products manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

    Product
    Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06)
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0661-2017·2017-04-19

    Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues

    Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.

    Product
    LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2017·2017-04-19

    Windstone Medical Packaging Recalls Cataract Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 4,065 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V262000·2017-04-19

    Winnebago Recalls 2014-2017 Motorhomes Due to Electrical Interference

    Winnebago is recalling 2014-2017 View, VIA, ERA, and Itasca Navion motorhomes because a radio module may interfere with the electrical system, potentially causing engine shutdown or power loss.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIA, VIEW, NAVION, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1943-2017·2017-04-19

    Dolcetta Rosemary Caramel Bar Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling 250 Rosemary Caramel Bars in Oregon and Washington due to undeclared soy lecithin.

    Product
    Rosemary Caramel Bar is dark chocolate with rosemary infused caramel, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box. The label declared: '"***Rosemary Caramel Bar *** 60% dark chocolate, cane sugar, cream, glucose (wheat), butter, rosemary, sea salt
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1819-2017·2017-04-19

    Intuitive Surgical Recalls da Vinci Xi Suction Irrigator Instruments

    Intuitive Surgical is recalling 90 da Vinci Xi Suction Irrigator instruments due to unexpected arm motion with specific software.

    Product
    da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE, EMBEDDED RLS, IS4000, A70_P6_B440; PN 610092-440. General and Plastic Surgery: The EndoWrist¿ Suction Irrigator is designed to be used in conjunction with an Intuitive Surgical da Vinci
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-1930-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Dark Chocolate Pretzel Santa for Undeclared Soy

    Dolcetta Artisan Sweets is recalling 30 boxes of Dark Chocolate Pretzel Santa because the product contains undeclared soy lecithin.

    Product
    Dark Chocolate Pretzel Santa, net wt. 150 g (5.3 oz) The label declared "***Ingredients: 60% dark chocolate, 49% milk chocolate, pretzels, butter, white chocolate, sea salt *** Contains wheat and milk***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1921-2017·2017-04-19

    J & J Distributing Recalls Rainbow Coleslaw Due to Metal Contamination

    J & J Distributing Company is recalling Rainbow Coleslaw because shredded carrots used as an ingredient were contaminated with metal pieces.

    Product
    Rainbow Coleslaw, 5 lbs for Food Service (Franchise) in Food service plastic bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1787-2017·2017-04-19

    Windstone Medical Recalls Dicken Eye Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 172 Dicken Eye Packs because the sterile packaging of the eye pads may be compromised.

    Product
    Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1788-2017·2017-04-19

    Windstone Medical Recalls Dr. Wischmeier Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,170 Dr. Wischmeier Packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1932-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Dark Orange Bars Due to Undeclared Soy

    Dolcetta Artisan Sweets is recalling 164 Dark Orange Bars distributed in Oregon and Washington because the product contains undeclared soy lecithin.

    Product
    Dark Orange Bar is dark chocolate with bits of candied orange zest, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1907-2017·2017-04-19

    SoyNut Butter Company Recalls Granola Due to E. coli O157 Risk

    The SoyNut Butter Company is recalling I.M. Healthy Raisin & Cranberry Granola due to potential E. coli O157 contamination.

    Product
    I.M. Healthy Raisin & Cranberry Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1944-2017·2017-04-19

    Dolcetta Salted Caramel Bonbons Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling Salted Caramel Bonbons because the product contains undeclared soy lecithin, a major food allergen.

    Product
    Salted Caramel Bonbons are molded chocolate shells filled with salted caramel ganache, 1.7 oz (48g), the product is placed into a clear plastic box package and then put into a paper box package. The label declared "***Salted Caramel Bonbons *** Shell: 60% dark chocolate, 32% w
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1902-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling I.M. Healthy Chunky SoyNut Butter due to potential E. coli O157 contamination. The product was distributed nationwide.

    Product
    I.M. Healthy, Chunky SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2017·2017-04-19

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

    Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

    Product
    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1911-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling B'Gan Quality Product SoyNut Butter due to potential E. coli O157 contamination.

    Product
    B'Gan Quality Product, SoyNut Butter, Creamy; Dist. By: S. Bertram Inc, Linden, NJ 07036
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1905-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling I.M. Healthy Chocolate SoyNut Butter due to potential E. coli O157 contamination.

    Product
    I.M. Healthy, Chocolate SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1906-2017·2017-04-19

    SoyNut Butter Company Recalls I.M. Healthy Granola Due to E. coli Risk

    The SoyNut Butter Company is recalling I.M. Healthy Original Granola due to potential contamination with E. coli O157.

    Product
    I.M. Healthy, Original Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1941-2017·2017-04-19

    Dolcetta Peanut Crisp Truffles Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling Peanut Crisp Truffles because the product contains undeclared soy lecithin, a potential allergen.

    Product
    Peanut Crisp Truffles are milk chocolate with peanut butter truffles, 3.9 oz (110g), individually wrapped in clear cellophane and then wrapped in a paper box. The label declared "***Peanut Crisp Truffles***49% milk chocolate, peanut butter, feuilletine (wheat), cocoa powder, s
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1909-2017·2017-04-19

    SoyNut Butter Company Recalls Blueberry Granola Due to E. coli Risk

    The SoyNut Butter Company is recalling I.M. Healthy Blueberry Granola nationwide due to potential contamination with E. coli O157.

    Product
    I.M. Healthy Blueberry Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1922-2017·2017-04-19

    Gerber Pasta Pick-Ups Cheese Ravioli Recalled for Missing Egg Allergen Label

    Gerber is recalling Pasta Pick-Ups Cheese Ravioli because the egg allergen is missing from the 'Contains' statement on the packaging.

    Product
    Gerber¿ Pasta Pick-Ups Cheese Ravioli Net Wt 6 oz (170g) Drained Wt 3 oz (85g) UPC 01500000907-6 , Truncated - written on package as: UPC 159070
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1884-2017·2017-04-19

    Companion Foods Recalls Szechuan Style Kung-Pao Sauce for Wheat Mislabeling

    Companion Foods Corp. is recalling Szechuan Style Kung-Pao Sauce because wheat is not properly declared in the ingredient list, posing a risk to individuals with wheat allergies.

    Product
    SZECHUAN STYLE KUNG-PAO SAUCE (HOT PAPAO LAJAN), 10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10395 9 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1883-2017·2017-04-19

    Vegetarian Minced Meat Recalled for Undeclared Wheat Allergen

    Companion Foods Corp. is recalling Vegetarian Minced Meat with Shiitake because an FDA inspection found wheat was not properly declared in the ingredient list.

    Product
    VEGETARIAN MINCED MEAT WITH SHIITAKE 5 1/3 oz.. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10932 6 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1903-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

    The SoyNut Butter Company is recalling I.M. Healthy Unsweetened SoyNut Butter due to potential E. coli O157 contamination. Consumers should stop using the product.

    Product
    I.M. Healthy, Unsweetened SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1785-2017·2017-04-19

    Windstone Medical Recalls Cataract Packs Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 7,508 cataract packs because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2017·2017-04-19

    GE Healthcare Recalls Vivid Ultrasound Systems Due to Patient Selection Error

    GE Healthcare is recalling Vivid Ultrasound systems because slow search times can cause operators to select the wrong patient, potentially leading to misdiagnosis.

    Product
    Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1784-2017·2017-04-19

    Windstone Medical Recalls Cataract Kits Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 990 cataract kits because the sterile packaging of the included eye pads may be compromised.

    Product
    Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2017·2017-04-19

    Roche Recalls Cobas 8100 Reformatter Modules Due to Rack Crash Risk

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a rack crash can cause sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1928-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Dark Chocolate Peppermint Snowflakes for Undeclared Soy

    Dolcetta Artisan Sweets is recalling 90 bags of Dark Chocolate Peppermint Snowflakes in Oregon and Washington due to undeclared soy lecithin.

    Product
    Dark Chocolate Peppermint Snowflakes are dark chocolate flavored with peppermint oil, 100g (3.5 oz), the product is wrapped in a plastic heat sealed bag.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1927-2017·2017-04-19

    Dolcetta Dark Chocolate Hazelnut Bar Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling 80 Dark Chocolate Hazelnut Bars distributed in Oregon and Washington due to undeclared soy lecithin.

    Product
    Dark Chocolate Hazelnut Bar is dark chocolate with milk chocolate and hazelnuts, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1778-2017·2017-04-19

    Merge Hemo software recall for incorrect FFR results display

    Merge Healthcare is recalling Merge Hemo software versions 9.10.0 through 9.40.0 because they may display incorrect Fractional Flow Reserve values during cardiac catheterization.

    Product
    Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2017·2017-04-19

    Hill-Rom TotalCare Bed Systems Recalled for Alarm Malfunction

    Hill-Rom is recalling TotalCare Bed Systems because the exit alarm may fail if armed for over 72 hours without triggering.

    Product
    TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
    Category
    Medical Device
    Distribution
    Distributed nationwide

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