The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
113
High
287
Moderate
299
Low
51

Of the 766 recalls this month scored against our rubric, 2% are Critical, 15% are Severe.

301–400 of 766

  • ModerateFDA (Devices)·Z-1012-2018·2018-03-21

    DePuy Global Unite Shoulder System Recall Due to Inverted Screw Assembly

    DePuy Orthopaedics is recalling 85 units of the Global Unite Platform Shoulder System because an inverted screw may cause the humeral stem to sit proud, potentially delaying surgery.

    Product
    The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LE¿O-1100-30-000 REV D.pdf.pdf, LE¿O-1100-40-000 REV D.pdf.pdf, LE¿O-110030100_REV D.pdf.pdf, LE¿O-110030110_REV D.pdf.pdf,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0994-2018·2018-03-21

    Arrow Central Venous Catheter Kits Recalled for Missing Identification Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access i
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0979-2018·2018-03-21

    Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching

    Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers. The size difference is visually recognizable to the user.

    Product
    Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0602-2018·2018-03-21

    Hetero Labs Recalls Valacyclovir Tablets Due to Temperature Exposure

    Hetero Labs Limited is recalling Valacyclovir Tablets USP 1 gram because they were exposed to higher temperatures during transport. The recall covers 48,132 bottles distributed nationwide.

    Product
    VALACYCLOVIR — VALACYCLOVIR (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1046-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE bag packaging may leave residue on the polished surface.

    Product
    CR-FLEX OPT FEM C-R MINUS CR-FLEX OPT FEM D-L MINUS CR-FLEX OPT FEM D-R MINUS CR-FLEX OPT FEM E-L MINUS CR-FLEX OPT FEM E-R MINUS CR-FLEX OPT FEM F-L MINUS CR-FLEX OPT FEM F-R MINUS CR-FLEX OPT FEM G-L MINUS CR-FLEX OPT FEM G-R MINUS This device is indicated for patien
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0921-2018·2018-03-21

    Ripple Chocolate Nutritious Pea Milk Recalled for High Coliform Levels

    Ripple Foods is recalling 448 cases of 48 oz. Chocolate Nutritious Pea Milk due to high levels of coliforms and Serratia liquefaciens.

    Product
    ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Calcium than Milk 32 mg DHA Omega 3's UPC: 8 55643 00607 6 Distributed by Ripple Foods, Emeryville, CA
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1038-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific hip and knee implants because the packaging bags may leave residue on the polished surfaces.

    Product
    LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0589-2018·2018-03-21

    Psoriasin Daytime Relief Cream Recalled for Subpotent Coal Tar Content

    Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.

    Product
    Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0936-2018·2018-03-21

    Medtronic Recalls Argyle Suction Tubing Due to Incorrect Packaging Labeling

    Medtronic is recalling 58,954 units of Argyle Suction Tubing because some pouches may be incorrectly labeled as Salem Sump Dual Lumen Stomach Tubes.

    Product
    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1000-2018·2018-03-21

    Arrow International Recalls Central Venous Access Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infus
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1004-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Stickers

    Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0996-2018·2018-03-21

    Arrow PICC Kits Recalled for Missing Lot and Expiration Labels

    Arrow International is recalling 23,904 PICC kits because some units are missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central v
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0969-2018·2018-03-21

    Randox Recalls Immunoassay Premium Controls Due to Stability Claim Failure

    Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.

    Product
    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1002-2018·2018-03-21

    Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels

    Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemothera
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1013-2018·2018-03-21

    Stryker T/Pump Temperature Therapy Pumps Recalled for Manual Error

    Stryker is recalling T/Pump temperature therapy pumps because the operations and maintenance manuals incorrectly added a sentence to the Indications for Use statement.

    Product
    T/Pump temperature therapy pump, Models TP700 and TP700C
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0998-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0999-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Information

    Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluid
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1001-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fl
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0970-2018·2018-03-21

    Randox Immunoassay Premium Plus Controls Recalled for Stability Issues

    Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.

    Product
    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1003-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0978-2018·2018-03-21

    Philips HeartStart XL+ Defibrillator Software Update Recall

    Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.

    Product
    HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0997-2018·2018-03-21

    Arrow International Recalls Central Venous Catheter Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venou
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0598-2018·2018-03-21

    Dr. Reddy's Recalls Clocortolone Pivalate Cream Due to Stability Issues

    Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.

    Product
    Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·024-2018·2018-03-20

    Mickey Brown Recalls Beef Burritos Produced Without Federal Inspection

    Mickey Brown, Inc. is recalling beef burrito products produced without federal inspection. No adverse reactions have been reported.

    Product
    Mickey Brown, Inc. — Mickey Brown, Inc Recalls Beef Burrito Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighCPSC·18127·2018-03-20

    Briggs & Stratton Recalls Riding Mowers Due to Reverse Mow Malfunction

    Briggs & Stratton is recalling Snapper, Simplicity, and Massey Ferguson riding mowers because a malfunctioning switch may allow the mower to mow while reversing, posing a risk of injury.

    Product
    Snapper, Simplicity, and Massey Ferguson riding mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V183000·2018-03-19

    REV Recalls 2018 Motorhomes Due to HVAC Fire Risk

    REV Recreation Group is recalling 600 2018 motorhomes because HVAC wires may disconnect, creating a fire risk if reconnected incorrectly.

    Product
    MONACO — MONACO, AMERICAN COACH, FLEETWOOD SIGNATURE, MARQUIS, AMERICAN REVOLUTION, AMERICAN DREAM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V181000·2018-03-19

    Entegra Aspire Recalled for Power Steering Hose Fire Risk

    Entegra Coach is recalling 2011-2012 and 2015-2016 Aspire motorhomes because an incorrectly routed power steering hose may cause electrical arcing and a fire.

    Product
    ENTEGRA — ENTEGRA ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V179000·2018-03-19

    Forest River Recalls Motorhomes Due to Power Steering Hose Fire Risk

    Forest River is recalling specific 2012-2017 motorhomes because an incorrectly routed power steering hose may rub against the starter motor, causing electrical arcing and a fire risk.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN, GLAVAL BUS CHARLESTON, BERKSHIRE, PATHFINDER, CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V182000·2018-03-19

    McElrath Trailers Recalling 2013-2018 Models Due to Weld Failure Risk

    McElrath Trailers is recalling specific 2013-2018 models because a weld on the trailer neck may fail, potentially causing loss of control and a crash.

    Product
    MCELRATH TRAILERS — MCELRATH TRAILERS VX50-800, 818I, VX30-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18731·2018-03-19

    Carrier Recalls Commercial Rooftop HVAC Units Due to Fire Hazard

    Carrier is recalling about 530 commercial rooftop HVAC units because a humidifier fan may fail to shut off, posing a fire hazard. No injuries have been reported.

    Product
    Carrier WeatherExpert commercial packaged rooftop HVAC units with humidimizer option
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·023-2018·2018-03-16

    Stampede Meat Recalls Beef Steaks Due to Salmonella Risk

    Stampede Meat is recalling approximately 484,800 pounds of frozen raw beef top sirloin steaks because a seasoning ingredient tested positive for Salmonella.

    Product
    Stampede Culinary Partners, Inc. — SMI Holdings, Inc Recalls Beef Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18T002000·2018-03-16

    Les Schwab Recalls Retreaded Truck Tires Due to Adhesion Defect

    Les Schwab is recalling specific retreaded steel-belted radial truck tires because the vulcanizing compound may not have fully cured, increasing the risk of tread separation and crashes.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·022-2018·2018-03-15

    Standard Meat Company Recalls Raw Beef Steaks Due to Salmonella Risk

    Standard Meat Company is recalling raw beef top sirloin steaks that may be contaminated with Salmonella. The products were shipped to restaurants nationwide.

    Product
    Standard Meat Company — Standard Meat Company Recalls Beef Products Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·021-2018·2018-03-15

    Johnsonville Recalls Smoked Pork Sausage Due to Possible Plastic Contamination

    Johnsonville is recalling approximately 109,603 pounds of smoked pork sausage products that may contain hard, green plastic pieces.

    Product
    Johnsonville, LLC — Johnsonville, LLC Recalls Smoked Pork Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V178000·2018-03-15

    Hino Recalls 2018-2019 Trucks Due to Engine Valve Train Defect

    Hino is recalling 2018-2019 NE8J, NJ8J, and NV8J trucks because engine valve train lock nuts may be loose, potentially causing engine damage and shutdown.

    Product
    HINO — HINO NJ8J, NV8J, NE8J
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18730·2018-03-15

    eheat Recalls Envi Wall Heaters Due to Overheating and Burn Hazard

    eheat is recalling about 35,000 Envi wall heaters sold in the U.S. and Canada due to a defect that can cause overheating, smoke, or melting, posing a burn hazard.

    Product
    Envi high-efficiency electric panel heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V175000·2018-03-15

    Pagani Recalls 2017 Huayra Vehicles Due to Battery Software Defect

    Pagani is recalling 2017 Huayra Coupe BC and Roadster vehicles because battery management software may prevent the car from starting or idling, increasing crash risk.

    Product
    PAGANI — PAGANI HUAYRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V177000·2018-03-15

    Mercedes-Benz Recalls GLC Models for Retracting Rear Seat Belt Latch Plates

    Mercedes-Benz is recalling certain 2016-2018 GLC models because rear seat belt latch plates may retract into the interior paneling, preventing use.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E, GLC300, AMG GLC43, GLC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18125·2018-03-15

    Louis Garneau Recalls Bicycle Helmets Due to Head Injury Risk

    Louis Garneau is recalling specific Course bicycle helmets because they do not meet federal impact safety standards, posing a risk of head injury.

    Product
    Bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18V176000·2018-03-15

    Toyota Recalls 2018 Prius C Vehicles for Missing Air Bag Labels

    Toyota is recalling 2018 Prius C vehicles sold in Puerto Rico because the front passenger air bag and child seating labels may be missing, increasing crash injury risk.

    Product
    TOYOTA — TOYOTA PRIUS C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0593-2018·2018-03-14

    Bella Capsules Recalled for Undeclared Sibutramine Content

    Bella All Natural is recalling Bella Capsules because they contain undeclared sibutramine, a withdrawn controlled substance, making them unapproved drugs.

    Product
    Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-0910-2018·2018-03-14

    Lotte Kancho Choco-Biscuit Recalled for Undeclared Peanut Allergen

    Lotte International America Corp. is recalling Lotte Kancho Choco-Biscuit products because peanut allergen was found during product sampling and testing.

    Product
    Lotte Kancho Choco-Biscuit; Sold as Lotte Kancho - 42 g -1.48 oz. UPC CODE: 8801062 144815; Lotte Kancho Cup - 95 g cup - UPC CODE: 8801062 516858; Lotte Kancho Multi - 168 g - UPC CODE: 8801062 144815. Master carton UPC: 1 8801062 133090 Ingredients: Wheat Flour, Su
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0579-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Stability Data Issues

    Apollo Care is recalling 360 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0580-2018·2018-03-14

    Apollo Care Recalls Vancomycin IV Bags Due to Unsupported Expiry Date

    Apollo Care is recalling 312 bags of Vancomycin IV solution because stability data does not support the assigned 90-day beyond use date.

    Product
    Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·18V172000·2018-03-14

    KME Predator Fire Apparatus Recalled for Front Axle Spindle Defect

    Kovatch Mobile Equipment is recalling specific KME Predator fire apparatus vehicles because inconsistent machining may cause front axle spindles to crack and fail, potentially leading to wheel separation.

    Product
    KME — KME PREDATOR TANKER, PREDATOR RESCUE, PREDATOR AERIAL, PREDATOR PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V173000·2018-03-14

    Maserati Recalls 2017 Quattroporte and Ghibli for Engine Software Defect

    Maserati is recalling 2017 Quattroporte and Ghibli vehicles because an engine software issue may cause the transmission to shift into neutral or the engine to shut off unexpectedly.

    Product
    MASERATI — MASERATI QUATTROPORTE, GHIBLI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0886-2018·2018-03-14

    Gasco Industrial Recalls BELCA Soy Sauce for Undeclared Wheat Allergen

    Gasco Industrial, Corp. is recalling BELCA Soy Sauce in Puerto Rico because the product contains an undeclared wheat allergen.

    Product
    BELCA Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Distribuido por: Mister Price Inc. San Juan, P.R. 00936
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0881-2018·2018-03-14

    King of Pops Recalls Key Lime Pie Pops for Undeclared Soy Allergen

    King of Pops is recalling Key Lime Pie Handcrafted All-Natural Pops because they contain undeclared soy. Consumers should stop eating the product.

    Product
    Key Lime Pie Handcrafted All-Natural Pop; Net Wt. 3.2 OZ (90g)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0882-2018·2018-03-14

    Bob's Red Mill Recalls Buttermilk Pancake Mix for Undeclared Milk

    Bob's Red Mill is recalling 25 lb. bags of Buttermilk Pancake and Waffle Mix because the label failed to list milk as an ingredient.

    Product
    Buttermilk Pancake and Waffle Mix, Item number: 6170B25, packaged in 25 lbs. bulk kraft bag. The label is read in parts: "***BUTTERMILK PANCAKE & WAFFLE MIX***Net Wt 25 LB *** INGREDIENTS: Organic Whole Grain Buckwheat Flour, Organic Stone Ground Whole Wheat Pastry Flour, Whea
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0902-2018·2018-03-14

    Synthes Recalls 2.5 mm Reaming Rods Due to Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.

    Product
    2.5 mm Reaming Rod, Ball tip with extension, 950 mm, sterile, Part Number: 351.707S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2018·2018-03-14

    Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

    Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.

    Product
    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2018·2018-03-14

    Toshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening

    Toshiba American Medical Systems is recalling 29 INFX-8000V and INFINIX CF-I/BP PLUS systems because fastening bolts on the ceiling drive loosened, disabling operation.

    Product
    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0903-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.

    Product
    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2018·2018-03-14

    Roche cobas 8000 Modular Analyzer Recall for Operator Injury Prevention

    Roche Diagnostics is recalling 245 cobas 8000 c 502 modules to add a warning to the manual, preventing operator injury during maintenance.

    Product
    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0905-2018·2018-03-14

    Synthes 2.5 mm Guide Rods Recalled for Potential Sterility Loss

    Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.

    Product
    2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2018·2018-03-14

    Philips Brilliance Big Bore CT Software Recall for Image Generation Errors

    Philips is recalling 119 Brilliance Big Bore CT scanners due to software errors that may prevent image generation or display incorrect settings.

    Product
    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0908-2018·2018-03-14

    Double Cola Cherry SKI Lemon Orange Soda Recalled for Missing Allergen Labeling

    Double-Cola Co. is recalling Cherry SKI Lemon Orange Authentic Citrus Soda 12 oz cans because the label failed to list Yellow #5 and Red 40.

    Product
    Cherry SKI LEMON ORANGE AUTHENTIC CITRUS SODA 12 oz can CONTAINS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, LEMON JUICE CONCENTRATE, ORANGE JUICE CONCENTRATE, CITRIC ACID, NATURAL FLAVOR, SODIUM BENZOATE (PRESERVATIVE), CAFFEINE, CELLULOSE GUM, RED #4, GUM ARABIC, BLUE #1. UPC
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0835-2018·2018-03-14

    Stryker Recalls StrykeFlow 2 System Due to Bioburden Testing Results

    Stryker is recalling 60,753 units of the StrykeFlow 2 System because routine bioburden testing found levels higher than internal acceptable rates.

    Product
    StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRI
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0904-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.

    Product
    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives nationwide due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 19 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7519, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2018·2018-03-14

    Medtronic BIO CAL Temperature Controller Recalled Due to Cleaning Protocol Issues

    Medtronic is recalling BIO CAL Temperature Controllers because it cannot develop a cleaning protocol that meets current industry standards. Users are advised to discontinue use and dispose of the devices.

    Product
    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0850-2018·2018-03-14

    Philips Network Firewall Recall Due to Defective Clock Component

    Philips is recalling 332 network firewalls used with IntelliVue systems due to a defective clock component that may cause loss of connection.

    Product
    Philips Network Firewall (Cisco ASA 5506), Model # 867098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2018·2018-03-14

    Mindray A-Series Anesthesia Delivery System Software Recall

    Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.

    Product
    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2018·2018-03-14

    Philips Recalls Brilliance Big Bore Oncology CT Scanners Due to Software Errors

    Philips Medical Systems is recalling 11 Brilliance Big Bore Oncology CT scanners due to software errors that may affect image generation and display settings.

    Product
    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0890-2018·2018-03-14

    Barq's Root Beer Cans Recalled for Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Barq's Root Beer cans due to sharp edges that could cause cuts.

    Product
    Barq's Root Beer 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0848-2018·2018-03-14

    DePuy Concorde Lift Driver Shaft Recalled for Potential Breakage

    DePuy Orthopaedics is recalling 130 units of the Concorde Lift Driver Shaft AO due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2018·2018-03-14

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2018·2018-03-14

    Toshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect

    Toshiba American Medical Systems Inc is recalling 19 INFX-8000C Fluoroscopic X-Ray Systems because fastening bolts on the ceiling drive loosened, causing the device to disable during operation.

    Product
    INFX-8000C Fluoroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0841-2018·2018-03-14

    Philips IQon Spectral CT Software Recall for Image Misrepresentation

    Philips is recalling 63 IQon Spectral CT systems due to software errors that may cause image misrepresentation or failure to generate images.

    Product
    IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0918-2018·2018-03-14

    Zimmer Biomet Flexible Shaft Instruments Recalled for Infection Risk

    Zimmer Biomet is recalling 457 Flexible Shaft instruments because they may not clean adequately, posing a risk of infection.

    Product
    Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Food)·F-0888-2018·2018-03-14

    Heartland Coca-Cola Recalls Pibb Xtra Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Pibb Xtra soda cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Pibb Xtra, Artificially Flavored Spicy Cherry Soda 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0906-2018·2018-03-14

    Dr Pepper Diet Cans Recalled Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Dr Pepper Diet cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Dr Pepper Diet, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of Dr Pepper Company, Plano, TX
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0931-2018·2018-03-14

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems in Florida due to potential energy range discrepancies in the first layer of irradiation plans.

    Product
    Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0889-2018·2018-03-14

    Heartland Coca-Cola Recalls Pibb Zero Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Pibb Zero soda cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Pibb Zero, Artificially Flavored Sugar Free Spicy Cherry Soda 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0893-2018·2018-03-14

    Heartland Coca-Cola Recalls Mello Yola Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Mello Yola citrus-flavored soda cans because sharp edges on the cans could cut consumers' mouths.

    Product
    Mello Yello, Citrus Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighCPSC·18123·2018-03-14

    Cameron Company Recalls Children's Tents Due to Laceration Hazard

    Cameron Company is recalling Playtime Pals Pop-Up Hideaway Hut children's tents because the fiberglass support rods can break and splinter, posing a laceration hazard.

    Product
    Playtime Pals Pop-Up Hideaway Hut children's tents
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0904-2018·2018-03-14

    Fresca Citrus Soda Recalled Due to Sharp Can Edges

    Heartland Coca-Cola Bottling Company is recalling Fresca Original Citrus Sparkling Flavored Soda cans because sharp edges were observed that could cause cuts to consumers' mouths.

    Product
    Fresca, Original Citrus Sparkling Flavored Soda, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0906-2018·2018-03-14

    Synthes Recalls 2.5 mm Titanium Calibrated Reaming Rods Due to Sterility Concerns

    Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.

    Product
    2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2018·2018-03-14

    DePuy Concorde Lift Torque Limiting Handle Recalled for Breakage Risk

    DePuy Orthopaedics is recalling 130 Concorde Lift Torque Limiting Handles due to a potential for intra-operative breakage of driver tips.

    Product
    Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2018·2018-03-14

    Medtronic Recalls Unimplanted SynchroMed II Pumps Due to Motor Stall Risk

    Medtronic is recalling unimplanted SynchroMed II Model 8637 pumps to address a design flaw that can cause motor stalls due to corrosion.

    Product
    Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2018·2018-03-14

    VITROS DAT Performance Verifier I recalled due to labeling issue

    Ortho-Clinical Diagnostics is recalling 349 units of VITROS DAT Performance Verifier I because the storage labeling is incorrect, which may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0891-2018·2018-03-14

    Heartland Coca-Cola Recalls Diet Coke Lime Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Diet Coke Lime cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Diet Coke Lime, 12 oz (355 mL) cans, packed in 12 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0837-2018·2018-03-14

    Stryker Recalls ACL Interface Screws Due to Bioburden Levels

    Stryker is recalling specific lots of ACL Interface Screws because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0896-2018·2018-03-14

    Heartland Coca-Cola Recalls Caffeine Free Coke Zero Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Caffeine Free Coke Zero cans because sharp edges were observed that could cause cuts to consumers' mouths.

    Product
    Caffeine Free Coke Zero, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0919-2018·2018-03-14

    Zimmer Biomet Recalls Sirus Drill Instruments Due to Cleaning Concerns

    Zimmer Biomet is recalling 127 Sirus Drill instruments because they may not be adequately cleaned, potentially leading to infection.

    Product
    Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0847-2018·2018-03-14

    Mindray A7 Anesthesia Delivery System Recalled for Software Defect

    Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.

    Product
    A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0922-2018·2018-03-14

    Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

    Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

    Product
    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratorie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0895-2018·2018-03-14

    Heartland Coca-Cola Recalls Diet Coke Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Diet Coke Caffeine Free cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Diet Coke Caffeine Free, 12 oz (355 mL) cans, packed in 12 and 24 packs, Canned under the authority of the Coca-Cola Company, Atlanta, GA
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0863-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb Inc is voluntarily recalling LASEREDGE Knives for ophthalmic surgery because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED (6/BOX), REF/PRODUCT CODE E7528G, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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