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.

401–500 of 766

  • HighFDA (Food)·F-0907-2018·2018-03-14

    Dr Pepper Cans Recalled Due to Sharp Edges Causing Potential Cuts

    Heartland Coca-Cola Bottling Company is recalling Dr Pepper 12 oz cans because sharp edges were observed, posing a risk of cuts to consumers' mouths.

    Product
    Dr Pepper, 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 (Food)·F-0894-2018·2018-03-14

    Heartland Coca-Cola Recalls Grape Fanta Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling 766,271 cases of Grape Fanta 12 oz cans because sharp edges on the cans could cause cuts to consumers' mouths.

    Product
    Grape Fanta, Grape 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-0927-2018·2018-03-14

    Medtronic O-arm O2 Imaging System Recalled for Electrical Shock Risk

    Medtronic is recalling 449 O-arm O2 Imaging Systems because servicing internal components may cause an electrical short, posing a shock hazard to field service technicians.

    Product
    O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of g
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0892-2018·2018-03-14

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

    Heartland Coca-Cola Bottling Company is recalling Sprite Zero cans because sharp edges on the cans could cut consumers' mouths.

    Product
    Sprite Zero, Lemon-Lime Soda, Zero Calories, 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-0898-2018·2018-03-14

    Heartland Coca-Cola Recalls Orange Fanta Cans Due to Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Orange Fanta cans because sharp edges on the cans could cause cuts to consumers' mouths.

    Product
    Orange Fanta, Orange soda, Naturally flavored, 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-0892-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blade Complaints

    Bausch & Lomb Inc Irb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7601G, 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 (Food)·F-0920-2018·2018-03-14

    Whole Alternatives Recalls Dark Chocolate Covered Almonds for Undeclared Milk

    Whole Alternatives LLC is recalling dark chocolate covered almonds because the label failed to declare milk, posing an allergy risk.

    Product
    Dark Chocolate Covered Almonds 9 oz clam shell & 25 lb box Ingredients: Dark Chocolate (Sugar, chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed with Alkali, Soy Lecithin (Emulsifier), Salt, Vanilla, Almonds and Confectioners Glaze. Sold under the brand names and Distrib
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0880-2018·2018-03-14

    Life Change Fat Burner Recalled for Unlabeled Soy Allergen

    Get The Tea is recalling Life Change Fat Burner because the product contains soy, which is not listed on the label.

    Product
    Life Change Fat Burner, 90 Gel Caps!, Burn Fat!, Remove fat from the liver! 1000mg; 2 capsules daily
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0901-2018·2018-03-14

    Coca-Cola Vanilla Cans Recalled for Sharp Edges Causing Mouth Cuts

    Heartland Coca-Cola Bottling Company is recalling 766,271 cases of 12 oz Vanilla Coca-Cola cans due to sharp edges that may cause cuts.

    Product
    Coca-Cola, Vanilla Flavor, 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-0905-2018·2018-03-14

    Heartland Coca-Cola Recalls Strawberry Fanta Cans Due to Sharp Edges

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

    Product
    Strawberry Fanta, Strawberry 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 (Food)·F-0900-2018·2018-03-14

    Coca-Cola Zero Sugar Cans Recalled for Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling specific lots of Coca-Cola Zero Sugar cans due to sharp edges that could cause mouth cuts.

    Product
    Coca-Cola, Zero Sugar, 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 (Food)·F-0884-2018·2018-03-14

    Emerald Glazed Walnuts Recalled for Undeclared Nuts

    Snyder's-Lance is voluntarily recalling 6.5 oz Emerald brand Glazed Walnuts due to undeclared peanuts, almonds, cashews, and pecans.

    Product
    Emerald brand Glazed Walnuts; Net WT. 6.5 OZ; Re-sealable pouch
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb Inc is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because an atypical volume of complaints indicates dull blades. The recall affects products lacking specific electro-polish and penetration force testing.

    Product
    LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR (6/BOX), REF/PRODUCT CODE E7500, 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-0901-2018·2018-03-14

    Synthes Reaming Rods Recalled for Potential Sterility Seal Defects

    Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.

    Product
    2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0887-2018·2018-03-14

    Gilster-Mary Lee Recalls Puffed Rice Cereal Due to Undeclared Wheat Allergen

    Gilster-Mary Lee Corp. is recalling Food Club and Essential Choice Puffed Rice cereal because it was packaged with undeclared wheat, posing a risk to consumers with wheat allergies.

    Product
    Food Club, Essential Choice, Puffed Rice, Net Wt 6 Oz (170 g), UPC 36800 31852
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0907-2018·2018-03-14

    Synthes Recalls Sterile Light Clip for Oracle Retractor Due to Potential Lack of Sterility

    Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.

    Product
    Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0909-2018·2018-03-14

    La Pasta Recalls Heinen's Potato Gnocchi for Undeclared Milk Allergen

    La Pasta, Inc. is recalling Heinen's Potato Gnocchi 9 oz. due to an undeclared milk allergen. The product was distributed in Illinois and Ohio.

    Product
    HEINEN'S Potato Gnocchi * Preservative Free * 9 oz. (225 g) in clear film plastic trays
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0903-2018·2018-03-14

    Heartland Coca-Cola Vanilla Zero Cans Recalled for Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling 766,271 cases of Coca-Cola Vanilla Zero 12 oz cans due to sharp edges that may cause mouth cuts.

    Product
    Coca-cola, Vanilla Zero, 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-0902-2018·2018-03-14

    Heartland Coca-Cola Recalls Sprite Cans With Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling Sprite cans due to sharp edges that could cause cuts to consumers' mouths.

    Product
    Sprite, Lemon-Lime Soda, 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 (Food)·F-0885-2018·2018-03-14

    NuChef Soy Sauce Recalled for Undeclared Wheat Allergen

    Gasco Industrial is recalling NuChef Soy Sauce in Puerto Rico due to an undeclared wheat allergen.

    Product
    NuChef Soy Sauce, Contenido Neto: Un Gal¿n (128 fl. oz), Packed for Northwestern Selecta
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0897-2018·2018-03-14

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

    Heartland Coca-Cola Bottling Company is recalling 766,271 cases of Diet Coke cans because sharp edges were observed, posing a risk of mouth cuts.

    Product
    Diet Coke, 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-0909-2018·2018-03-14

    Roche cobas 6000 Modular Series System Warning Added to Prevent Operator Injury

    Roche Diagnostics is adding a warning to cobas 6000 and 8000 Modular Series Operator Manuals to prevent operator injury during maintenance.

    Product
    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-0899-2018·2018-03-14

    Heartland Coca-Cola Recalls Cans with Sharp Edges

    Heartland Coca-Cola Bottling Company is recalling specific cans of Coca-Cola, Original Taste, because sharp edges were observed that could cause cuts to consumers' mouths.

    Product
    Coca-Cola, Original Taste, 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 (Food)·F-0883-2018·2018-03-14

    Vitalab Vitamin C Supplement Recalled for Undeclared Milk Allergen

    Vitalab Co Inc is recalling specific lots of Natural Source Vitamin C dietary supplements because they contain lactose but fail to declare the major food allergen milk on the label.

    Product
    Product packaged in the following ways A) Sonne's, No. 17, Natural Source Vitamin C, Dietary Supplement, (920 mg tablet wt.) Contents - 120 Tablets, National Distributors: Sonne's Organic Foods, Inc. N. Kansas City, MO 64116; B) Springreen, No. 87, Natural Source Vitamin C, Dieta
    Category
    Food
    Distribution
    29 states
  • ModerateFDA (Food)·F-0944-2018·2018-03-14

    Springside Monterey Jack Ghost Pepper Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling specific lots of Monterey Jack Ghost Pepper Cheese because the milk used may have been held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Ghost Pepper Cheese packaged in the following sizes: Net Wt. 8 oz., 1 lb., 5 lbs., and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0943-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Issue

    Springside Monterey Jack Pueblo Cheese is being recalled because it may have been made with milk that was held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Pueblo Cheese packaged in the following sizes: Net Wt. 8 oz., and 5 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0864-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.

    Product
    LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE (6/BOX), REF/PRODUCT CODE E7529, 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
  • ModerateFDA (Devices)·Z-0891-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7601, 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
  • ModerateFDA (Devices)·Z-0915-2018·2018-03-14

    Ortho-Clinical VITROS DAT Performance Verifier V Recall for Storage Labeling Issues

    Ortho-Clinical Diagnostics is recalling VITROS DAT Performance Verifier V units due to storage labeling errors that may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0883-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, 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
  • ModerateFDA (Devices)·Z-0865-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 30 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7530, 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
  • ModerateFDA (Devices)·Z-0895-2018·2018-03-14

    Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues

    Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0917-2018·2018-03-14

    Stryker Recalls Reprocessed EP Catheters Due to Navigation System Error

    Stryker is recalling eight reprocessed electrophysiology catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the card
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE (6/BOX), REF/PRODUCT CODE E7557, 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
  • ModerateFDA (Devices)·Z-0867-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7548ADB, 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
  • ModerateFDA (Devices)·Z-0870-2018·2018-03-14

    Bausch + Lomb Recalls LASEREDGE Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling LASEREDGE Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7550ADB, 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
  • ModerateFDA (Devices)·Z-0928-2018·2018-03-14

    Medtronic O-arm 1000 X-ray System Software Update Recall

    Medtronic is recalling 253 O-arm 1000 mobile X-ray systems to implement a software update that resolves multiple operational and imaging defects.

    Product
    O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BASE OARM Bl70000028100 SYS 100V, Product Number: Bl70000028100 (UDI: 00643169354418); (2) Model: BASE OARM Bl70000028120 SYS 120V, Product Number: Bl70000028120 (UDI: 00643169353411); (3) Model: BASE OARM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0945-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Onion & Chives Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Onion & Chives Cheese Net Wt. 1 lb.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0876-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

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

    Product
    LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7552ADB, 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
  • ModerateFDA (Food)·F-0950-2018·2018-03-14

    Springside Monterey Jack Chicken Soup Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Chicken Soup Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Chicken Soup Cheese Packaged in the following sizes: Net Wt. 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0949-2018·2018-03-14

    Springside Monterey Jack Chipotle Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Chipotle Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Chipotle Cheese Packaged in the following sizes: Net Wt. 8 oz., 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0946-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Defect

    Springside Monterey Jack Morel & Leek Cheese is being recalled because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Morel & Leek Cheese Packaged in the following sizes: Net Wt. 8 oz., 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0940-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled Due to Pasteurization Error

    Springside Cheese Corp is recalling 129.4 lbs of Monterey Jack Garden Vegetable Cheese because the milk may not have been pasteurized long enough.

    Product
    Springside Monterey Jack Garden Vegetable Cheese, 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0890-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED (6/BOX), REF/PRODUCT CODE E7600, 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
  • ModerateFDA (Devices)·Z-0894-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP (6/BOX)(6/BOX), REF/PRODUCT CODE E7759A, 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
  • ModerateFDA (Food)·F-0942-2018·2018-03-14

    Springside Monterey Jack Jalapeno Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Jalapeno Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Jalapeno Cheese packaged in the following sizes: Net Wt. 8 oz., 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0947-2018·2018-03-14

    Springside Monterey Jack Habanero Cheese Recalled for Pasteurization Issue

    Springside Cheese Corp is recalling Monterey Jack Habanero Cheese because it may have been made with milk held for 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Habanero Cheese Packaged in the following sizes: Net Wt. 8 oz., 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0583-2018·2018-03-14

    Spirit Pharmaceuticals Recalls Valumeds Ibuprofen Due to CGMP Deviations

    Spirit Pharmaceuticals is recalling 144 bottles of Valumeds Ibuprofen 200 mg in New York due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    VALUMEDS IBUPROFEN — VALUMEDS IBUPROFEN (IBUPROFEN)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0914-2018·2018-03-14

    Ranitidine Tablets Recalled for Failed Stability Specifications

    Mckesson Packaging Services is recalling Ranitidine Tablets 150 mg due to failed stability specifications. The recall affects 17,192 cartons distributed nationwide.

    Product
    RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0926-2018·2018-03-14

    Abbott i-STAT DE Handheld Module Software Update Recall

    Abbott Point Of Care Inc. is recalling 894 i-STAT DE handheld data processing modules because a software upgrade resets customized settings and prevents certain data from updating.

    Product
    i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0886-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR (6/BOX), REF/PRODUCT CODE E7575, 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
  • ModerateFDA (Drugs)·D-0590-2018·2018-03-14

    Bayer Recalls Coppertone Kids Sunscreen Spray Due to Labeling Error

    Bayer HealthCare Pharmaceuticals is recalling 528 bottles of Coppertone Kids Sunscreen Spray in Arkansas due to a label mix-up.

    Product
    Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0888-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7592, 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
  • ModerateFDA (Devices)·Z-0898-2018·2018-03-14

    Boston Scientific Recalls Auriga XL 4007 Laser Systems Due to Assembly Defect

    Boston Scientific is recalling nine Auriga XL 4007 Laser Systems because incorrectly assembled trigger wire components may cause error codes or prevent the consoles from starting.

    Product
    Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0882-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7557A, 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
  • ModerateFDA (Devices)·Z-0868-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of dull blade complaints.

    Product
    LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, 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
  • ModerateFDA (Devices)·Z-0873-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1.2 million LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7551ADB, 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
  • ModerateFDA (Devices)·Z-0852-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510, 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
  • ModerateFDA (Devices)·Z-0838-2018·2018-03-14

    Stryker Recalls ACL Disposable Packs Due to Bioburden Levels

    Stryker is recalling ACL Disposable Pack Bone-Tendon-Bone units because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0866-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because an atypical volume of complaints reported dull blades.

    Product
    LASEREDGE Knives, 30 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7530T, 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
  • ModerateFDA (Devices)·Z-0874-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED (6/BOX), REF/PRODUCT CODE E7551ADBG, 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
  • ModerateFDA (Devices)·Z-0859-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 20 GAUGE MVR BLADE (6/BOX), REF/PRODUCT CODE E7520, 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
  • ModerateFDA (Devices)·Z-0853-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP (6/BOX), REF/PRODUCT CODE E7510AT, 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
  • ModerateFDA (Devices)·Z-0856-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

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

    Product
    LASEREDGE Knives, 15 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7515, 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
  • ModerateFDA (Devices)·Z-0880-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED (6/BOX), REF/PRODUCT CODE E7556AG, 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
  • ModerateFDA (Devices)·Z-0869-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, 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
  • ModerateFDA (Devices)·Z-0877-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7553A, 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
  • ModerateFDA (Devices)·Z-0726-2018·2018-03-14

    NeuroLogica GC80 Digital X-ray Imaging System Recalled for Overexposure

    NeuroLogica Corporation is recalling 45 units of the GC80 Digital X-ray Imaging System because images obtained during examinations may be overexposed.

    Product
    The GC80 Digital X-ray Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0871-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

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

    Product
    LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, 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
  • ModerateFDA (Devices)·Z-0916-2018·2018-03-14

    Stryker Reprocessed EP Catheters Recalled for EEPROM Chip Error

    Stryker is recalling 170 reprocessed EP catheters because an EEPROM chip error may occur when used with CARTO navigation systems.

    Product
    Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx. The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the card
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0951-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Defect

    Springside Monterey Jack Caribbean Red Hot Cheese is being recalled because it may have been made with milk held for only 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Caribbean Red Hot Cheese Packaged in the following sizes: Net Wt. 1 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0948-2018·2018-03-14

    Springside Monterey Jack Cheese Recalled for Pasteurization Deficiency

    Springside Cheese Corp is recalling Monterey Jack cheese because it may have been made with milk held for only 13.8 seconds during pasteurization.

    Product
    Springside Monterey Jack Cheese Packaged in the following sizes: Net Wt. 8 oz., 5 lb. and 40 lbs.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0855-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

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

    Product
    LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED (6/BOX), REF/PRODUCT CODE E7510G, 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
  • ModerateFDA (Drugs)·D-0576-2018·2018-03-14

    Hospira Recalls Labetalol Hydrochloride Injection Due to Cracked Glass Vials

    Hospira Inc. is recalling Labetalol Hydrochloride Injection vials because of cracked glass at the rim, which is covered by the stopper and crimp seal.

    Product
    LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556A, 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
  • ModerateFDA (Devices)·Z-0897-2018·2018-03-14

    Boston Scientific Recalls Two Auriga 30 Laser Systems for Assembly Defect

    Boston Scientific is recalling two Auriga 30 Laser Systems because incorrectly assembled trigger wires may cause error codes or failure to start the console.

    Product
    Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0884-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7560A, 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
  • ModerateFDA (Drugs)·D-0581-2018·2018-03-14

    Osmotica Recalls Subpotent Methylphenidate Hydrochloride Extended-Release Tablets

    Osmotica Pharmaceutical Corp is recalling specific lots of Methylphenidate Hydrochloride Extended-Release Tablets because some 100-count bottles contain one 27 mg tablet instead of 36 mg.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0861-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 (6/BOX), REF/PRODUCT CODE E7527, 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
  • ModerateFDA (Devices)·Z-0862-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 (6/BOX), REF/PRODUCT CODE E7528, 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
  • ModerateFDA (Devices)·Z-0887-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM (6/BOX), REF/PRODUCT CODE E7587A, 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
  • ModerateFDA (Devices)·Z-0885-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling specific LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED (6/BOX), REF/PRODUCT CODE E7561A, 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
  • ModerateFDA (Devices)·Z-0889-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling 1,236,749 LaserEdge Knives used in ophthalmic surgery because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7593, 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
  • ModerateFDA (Devices)·Z-0879-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL (6/BOX), REF/PRODUCT CODE E7556ADB, 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
  • ModerateFDA (Devices)·Z-0836-2018·2018-03-14

    Stryker AHTO Tube Set Recalled for High Bioburden Levels

    Stryker is recalling AHTO Tube Sets labeled sterile because routine testing found bioburden levels higher than internal acceptable rates.

    Product
    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0914-2018·2018-03-14

    Ortho-Clinical VITROS Performance Verifier IV Recall for Storage Labeling

    Ortho-Clinical Diagnostics is recalling 196 units of VITROS Chemistry Products DAT Performance Verifier IV because storage labeling errors may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0582-2018·2018-03-14

    Kalchem Recalls Vardenafil HCl Due to Missing Stability Data

    Kalchem International is recalling Vardenafil HCl 500 GM jars due to a lack of stability data supporting the expiration date.

    Product
    Vardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0925-2018·2018-03-14

    Z-Medica Recalls QuikClot TraumaPad Dressings Due to Labeling Error

    Z-Medica is recalling 4,890 units of QuikClot TraumaPad dressings because one pouch in a box was mislabeled as a different product, though the contents were correct.

    Product
    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0857-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 15 DEGREE STAB BLADE TIP (6/BOX), REF/PRODUCT CODE E7515T, 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
  • ModerateFDA (Devices)·Z-0924-2018·2018-03-14

    Wiener Lab Chagas Disease Diagnostic Test Recalled for Expiration Concerns

    Wiener Laboratories is recalling CHAGATEST ELISA RECOMBINANTE V. 3.0 diagnostic tests because internal testing suggests they may not reach their indicated expiration dates.

    Product
    Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0932-2018·2018-03-14

    Cypress Medical Products Recalls Skin Staple Remover Kits Due to Iodine Levels

    Cypress Medical Products LLC is recalling specific surgical kits because they do not meet iodine assay requirements for their 36-month expiration dating.

    Product
    241-McKesson Premium Skin Staple Remover Kit, Item #100123, McKesson I.V. Start Kit, 100124-McKesson Suture Removal Kit, and 82-15 Cypress Medical Products Skin Staple Remover Kit. McKesson Item # 241, 100123, and 100124, Cypress Item # 82-15 Manual surgical instrument for ge
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0854-2018·2018-03-14

    Bausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch & Lomb is voluntarily recalling LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, CRESCENT BLADE BEVELED DN (6/BOX), REF/PRODUCT CODE E7510D, 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
  • ModerateFDA (Devices)·Z-0899-2018·2018-03-14

    Medical Device Recall: Silicone Fluted Round Drain and Connector

    Degania Silicone, Ltd. is recalling Silicone Fluted Round Drain 24Fr and Connector units because sterile pouches are missing labels. The boxes are properly labeled, and only lot P1607442 is affected.

    Product
    Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0912-2018·2018-03-14

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products DAT Performance Verifier II

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DAT Performance Verifier II because storage labeling errors may cause lower than expected VITROS BENZ results.

    Product
    VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0920-2018·2018-03-14

    Signature Ceramic Femoral Head Recalled for Mislabeled Packaging

    Signature Orthopedics is recalling 10 ceramic femoral heads because the packaging labels do not match the component sizes, which may cause surgical delays.

    Product
    Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE lin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0860-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 22.5 DEGREE STAB BLADE (6/BOX), REF/PRODUCT CODE E7522, 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
  • ModerateFDA (Devices)·Z-0872-2018·2018-03-14

    Bausch + Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades

    Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge ophthalmic knives because of an atypical volume of complaints regarding dull blades.

    Product
    LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7551A, 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
  • ModerateFDA (Devices)·Z-0913-2018·2018-03-14

    Ortho-Clinical Recalls VITROS DAT Performance Verifier III Due to Labeling Error

    Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.

    Product
    VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide

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