The Recall Desk

Archive

April 2017 recalls

850 recalls were announced in April 2017.

What the numbers show

Critical
98
Severe
177
High
432
Moderate
121
Low
22

Of the 850 recalls this month scored against our rubric, 12% are Critical, 21% are Severe.

201–300 of 850

  • 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-1852-2017·2017-04-26

    Verathon Recalls GVL 2 Stat Blades Packaged with Incorrect Size

    Verathon is recalling GVL 2 Stat blades (lot GC32825) because they were physically packaged with the incorrect size device, GVL 1 Stat blades.

    Product
    It is recommended for patients with weight/size between 4-22 lbs (1.8-10 kg). Part Number 0270-0429: GVL 2 Stat (box of 10 Stats). Part Number 0574-0027: GVL 2 Stat (single pouched Stat). Part Number 0270-0662: GlideScope AVL Video Baton 1-2 Kit (where one box of 10, part…
    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-1857-2017·2017-04-26

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

    Smith & Nephew is recalling 197 units of D-RAD locking screws because the expiration dates on the labels are incorrect and later than the actual expiration dates.

    Product
    D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422 (e) 2.4MM X 24MM, RES 74692424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
  • ModerateFDA (Devices)·Z-1854-2017·2017-04-26

    Smith & Nephew Recalls Peri-Loc VLP Self-Tapping Cortex Screws Due to Labeling Error

    Smith & Nephew is recalling specific Peri-Loc VLP self-tapping cortex screws because the expiration dates printed on the labels are incorrect and later than the actual dates.

    Product
    Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
    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
  • 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…
    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-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
  • 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
  • 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
  • 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·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·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
  • 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
  • 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 WHITEWATER, MT. MCKINLEY
    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
  • 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
  • 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-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-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
  • 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-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…
    Category
    Food
    Distribution
    2 states
  • 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-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-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
  • 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
  • SevereFDA (Food)·F-1912-2017·2017-04-19

    Bak EZ Mantecada Muffins Recalled for Undeclared Milk Allergen

    Bak EZ is recalling 7-Eleven Mantecada Muffins because they contain milk, which is not listed on the label.

    Product
    7-Eleven, Mantecada MUFFIN, Net Wt. 4 oz. , UPC 05254859241-7, in clear flexible plastic, Distributed by 7-Eleven, Inc., Irving, TX 750634.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (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
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1910-2017·2017-04-19

    SoyNut Butter Company Recalls Carb Not Beanit Butter Due to E. coli Risk

    The SoyNut Butter Company is recalling Dixie Diners' Club Carb Not Beanit Butter due to potential E. coli O157 contamination.

    Product
    Dixie Diners' Club Carb Not Beanit Butter, 15oz., Dixie USA, Inc., P.O. Box 1969, Tomball, TX 77377
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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
  • 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 (Food)·F-1860-2017·2017-04-19

    Nonna Foods Recalls Lidia's Marinara Sauce for Undeclared Milk

    Nonna Foods is recalling Lidia's Marinara Sauce because it may contain undeclared milk due to a potential product mix-up.

    Product
    LIDIA'S MARINARA, NET WT 25 oz (708g), UPC 897712001018 --- Manufactured for Nonna Foods LLC Woodbury, NY 11797
    Category
    Food
    Distribution
    41 states
  • SevereFDA (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
  • SevereFDA (Food)·F-1926-2017·2017-04-19

    Dolcetta Dark Chocolate Coconut Bar Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling 300 Dark Chocolate Coconut Bars distributed in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    Dark Chocolate Coconut Bar is dark chocolate with white chocolate and coconut, 1.2 oz (33g), product wrapped in metal foil and then wrapped in paper box.
    Category
    Food
    Distribution
    2 states
  • 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
  • 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 (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-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 (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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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
  • SevereFDA (Food)·F-1908-2017·2017-04-19

    I.M. Healthy Apple Granola Recalled for Potential E. coli O157 Contamination

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

    Product
    I.M. Healthy Apple Granola; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    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 (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-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
  • 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-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-1904-2017·2017-04-19

    SoyNut Butter Recalled for Potential E. coli O157 Contamination

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

    Product
    I.M. Healthy, Honey Creamy SoyNut Butter; Peanut Free; The SoyNut butter Company, Glenview, IL 60025
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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 (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…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (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
  • 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 (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 (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
  • HighFDA (Food)·F-1935-2017·2017-04-19

    Dolcetta Artisan Sweets Recalls Hot Cocoa Hearts for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling 180 boxes of Hot Cocoa Hearts sold in Oregon and Washington due to undeclared soy lecithin.

    Product
    Hot Cocoa Heart is dark chocolate shell filled with dry cocoa mix, 2.8 oz (80g), the product is packaged in a clear plastic box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1936-2017·2017-04-19

    Dolcetta Hot Cocoa Snowballs Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling Hot Cocoa Snowballs because they contain undeclared soy lecithin, a common allergen.

    Product
    Hot Cocoa Snowballs contain chocolate shell filled with dry hot cocoa mix, 100g (3.5 oz), the product is packaged in a clear plastic box.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1945-2017·2017-04-19

    Dolcetta Salty Caramel Truffles Recalled for Undeclared Soy and Milk

    Dolcetta Artisan Sweets is recalling 360 boxes of Salty Caramel Truffles in Oregon and Washington due to undeclared soy lecithin and milk.

    Product
    Salty Caramel Truffles are dark chocolate with salted caramel ganache, 3.9 oz (110g), individually wrapped in cellophane and then wrapped in a paper box. The label declared "***Salty Caramels***Cane sugar, cream, butter, golden syrup, sea salt, bourbon vanilla bean***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1880-2017·2017-04-19

    Braised Bamboo Shoot Tips Recalled for Wheat Allergen Mislabeling

    Companion Foods Corp. is recalling Braised Bamboo Shoot Tips because wheat is not properly declared in the ingredient list.

    Product
    BRAISED BAMBOO SHOOT TIPS 10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10060 6 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1757-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 ESU Cartons with Non-Sterile Handpiece Sheaths

    ConMed is recalling Hyfrecator 2000 ESU cartons because they were packaged with non-sterile handpiece sheaths labeled as sterile, posing a risk of infection.

    Product
    Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 115 VOLTS AC, REF/Catalog Number 7-900-115, Rx Only . There is no problem with the Hyfrecator 2000 Electrosurgical Units.…
    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-1769-2017·2017-04-19

    Datascope Recalls Custom Tubing Packs Due to Assembly Error

    Datascope Corporation is recalling 21 custom tubing packs with Bioline coating due to a reported assembly error on the oxygenator line.

    Product
    Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be…
    Category
    Medical Device
    Distribution
    1 state
  • 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 (Food)·F-1939-2017·2017-04-19

    Dolcetta Chocolate Almond Toffee Tree Recalled for Undeclared Soy Lecithin

    Dolcetta Artisan Sweets is recalling 30 bags of Milk Chocolate Almond Toffee Tree in Oregon and Washington due to undeclared soy lecithin.

    Product
    Milk Chocolate Almond Toffee Tree contains 3D chocolate holiday tree with toffee and almonds, net wt. 140g (4.9 oz), Product packaged in clear plastic box with ribbon.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1760-2017·2017-04-19

    ConMed Recalls Hyfrecator 2000 Handpiece Sheaths Due to Sterility Labeling Error

    ConMed is recalling Hyfrecator 2000 handpiece sheaths because non-sterile units were packaged in pouches labeled as sterile, posing a risk of infection.

    Product
    HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single Patient Use -- CONMED CORPORATION, 525 FRENCH ROAD UTICA, NY 13502. --- There is no problem with the Hyfrecator 2000 Electrosurgical Units or with cases of P/N 7-796-19 sold in cases as P/N…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2017·2017-04-19

    Micromedics FibriJet Endoscopic Catheter Introducer Recalled for Packaging Seal Defects

    Micromedics, Inc. is recalling 273 units of FibriJet Endoscopic Catheter Introducers because small channels in the sterile packaging seal may compromise package integrity and sterility assurance.

    Product
    Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1918-2017·2017-04-19

    J & J Distributing Recalls Detox Salad Due to Metal Contamination

    J & J Distributing Company is recalling 7 cases of Detox Salad because shredded carrots used as an ingredient were contaminated with metal pieces.

    Product
    Detox Salad, 8 oz. Plastic deli container with various brand names: Cub Foods (Fresh) UPC 610014-155698 , Cuttin' Time UPC 610014-160876, .Country Market UPC610014-154929 , Jerry's UPC 610014-154103.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1798-2017·2017-04-19

    Windstone Medical Setup Packs Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling 500 Setup Packs containing Medtronic Curity Eye Pads due to potential sterile packaging compromise.

    Product
    Setup Pack, part number AMS3112(A 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-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 (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…
    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-1881-2017·2017-04-19

    Companion Foods Recalls Braised Bean Curd for Wheat Mislabeling

    Companion Foods Corp. is recalling Braised Bean Curd (Mock Chicken) because wheat is not properly declared as a sub-ingredient in the ingredient list.

    Product
    BRAISED BEAN CURD (MOCK CHICKEN)10 oz. cans, 24 cans per case. Product of Taiwan UPC CODE: 0 76277 10419 2 Companion Foods Corp. Taipei, Taiwan
    Category
    Food
    Distribution
    3 states

Looking for a different month? Back to 2017.