The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
242
High
366
Moderate
190
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

301–400 of 863

  • SevereNHTSA·18V530000·2018-08-15

    KZRV Connect Recalled for Propane Line Fire Risk

    KZRV is recalling 2018-2019 Connect trailers because liquid propane lines routed through the wheel well may be damaged by road debris, increasing fire risk.

    Product
    KZRV — KZRV CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1046-2018·2018-08-15

    Akorn Recalls Lidocaine and Prilocaine Cream Due to Impurity

    Akorn, Inc. is recalling Lidocaine 2.5% and Prilocaine Cream because routine stability testing found an unknown impurity.

    Product
    Lidocaine 2.5% and Prilocaine Cream, 2.5%. 30g tube, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-667-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1738-2018·2018-08-15

    Whole Foods Recalls Bakery Products for Undeclared Soy Flour

    Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CAKE BERRY CHANTILLY 9IN
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1051-2018·2018-08-15

    Guardian Pharmacy Recalls Morphine Sulfate CADD Due to Sterility Concerns

    Guardian Pharmacy Services is recalling specific lots of compounded Morphine Sulfate 1 mg/mL CADD 25 mL due to a lack of sterility assurance.

    Product
    Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1749-2018·2018-08-15

    Whole Foods Recalls Strawberry and Cream Cake for Undeclared Soy

    Whole Foods Market is recalling Strawberry and Cream 4-inch cakes made in Mid-Atlantic stores because they failed to declare soy flour as an ingredient.

    Product
    CAKE STRAWBERRY AND CREAM 4IN
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V532000·2018-08-15

    Winnebago and Itasca Motorhomes Recalled for Propane Hose Leak Risk

    Winnebago is recalling 2012-2013 Era, View, Via, Itasca Navion, and Reyo motorhomes because high-pressure propane hoses may harden and leak, increasing fire risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, REYO, VIA, ERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2018·2018-08-15

    Pharmalucence Recalls Technetium TC 99M Medronate Kits Due to Sterility Breach

    Pharmalucence, Inc. is recalling 95 kits of Technetium TC 99M Medronate due to a reported breach of sterility. The affected product is distributed nationwide.

    Product
    KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE — KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1066-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL 750 mL ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2681-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1064-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Ropivacaine HCl 2 mg/mL in ON-Q Pumps due to a lack of sterility assurance. The affected product was distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1059-2018·2018-08-15

    Guardian Pharmacy Recalls Hyaluronidase Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 442 syringes of Hyaluronidase 150 units/mL in Texas due to a lack of sterility assurance.

    Product
    Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1739-2018·2018-08-15

    Whole Foods Recalls Bakery Products for Undeclared Soy Flour

    Whole Foods Market is recalling bakery products sold in Mid-Atlantic stores between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CAKE BLUEBERRY LEMON 6 IN
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V536000·2018-08-15

    Volkswagen Recalls Passat and Atlas for Brake Caliper Bolt Issue

    Volkswagen is recalling 2017-2018 Passat and 2018 Atlas vehicles because brake caliper bracket bolts may be loose, potentially reducing braking ability.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1735-2018·2018-08-15

    Whole Foods Recalls Vanilla Cupcakes for Undeclared Soy Flour

    Whole Foods Market is recalling vanilla cupcakes sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CUPCAKE VANILLA, 4.5 Ounce
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1751-2018·2018-08-15

    Whole Foods Recalls Fresh Fruit Parfait for Undeclared Soy Flour

    Whole Foods Market is recalling 1.0-pound Parfait Fresh Fruit products made in Mid-Atlantic stores because they failed to declare soy flour as an ingredient.

    Product
    PARFAIT FRESH FRUIT , 1.0 Pound
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1038-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ 160/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1065-2018·2018-08-15

    Guardian Pharmacy Recalls Ropivacaine HCl ON-Q Pumps for Sterility Concerns

    Guardian Pharmacy Services is recalling 25 units of Ropivacaine HCl 2 mg/mL 550 mL ON-Q Pumps due to a lack of sterility assurance. The products were distributed in Texas.

    Product
    Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1770-2018·2018-08-15

    Pictsweet Farms Baby Brussels Sprouts Recalled for Undeclared Allergens

    The Pictsweet Company is recalling Pictsweet Farms Steam'ables Baby Brussels Sprouts due to undeclared allergens on the labeling.

    Product
    Pictsweet Farms Steam'ables Baby Brussels Sprouts***NET WT 12 OZ (340g)***THIS SIDE UP IN MICROWAVE***Nutrition Facts***INGREDIENTS: BRUSSEL SPROUTS***
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2712-2018·2018-08-15

    Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1062-2018·2018-08-15

    Guardian Pharmacy Recalls Methylene Blue Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 95 vials of Methylene Blue 10 mg/mL in 1 mL syringes due to a lack of sterility assurance. The product was distributed in Texas.

    Product
    Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2018·2018-08-15

    Guardian Pharmacy Recalls B-Complex Due to Lack of Sterility Assurance

    Guardian Pharmacy Services is recalling B-Complex products in 100 mL bags and vials due to a lack of sterility assurance. The affected units were distributed in Texas.

    Product
    B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1069-2018·2018-08-15

    Guardian Pharmacy Recalls Lidocaine Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 250 syringes of Lidocaine 3% in Texas due to a lack of sterility assurance.

    Product
    Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2736-2018·2018-08-15

    FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints

    Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.

    Product
    iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1061-2018·2018-08-15

    Guardian Pharmacy Recalls Medroxyprogesterone Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 60 vials of compounded Medroxyprogesterone 150 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1771-2018·2018-08-15

    YWAM Faith Harvest Helpers Recalls Canned Salmon Due to Process Violation

    YWAM Faith Harvest Helpers is recalling 4,818 cans of salmon because the firm lacked a scheduled process for manufacturing low-acid canned food.

    Product
    Canned Salmon in unlabeled 8oz metal cans. Cans are packaged into a case of 92 cans. The case label is read: "Canned Salmon***Product of U.S.A. Net. Wt. 62 lbs. Packed by: Faith Harvest Helpers 12643 Case Rd SW Olympia, WA 98512***"
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1122-2018·2018-08-15

    World Organix Recalls Blissful Remedies Red Maeng Da Capsules for Microbial Contamination

    World Organix, LLC is recalling Blissful Remedies Red Maeng Da capsules due to potential high microbial loads. The recall covers 789 pouches distributed nationwide.

    Product
    Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1037-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2660-2018·2018-08-15

    Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk

    Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1830-2018·2018-08-15

    Franz Premium Pub Buns Recalled for Undeclared Soy Allergen

    Portland French Bakery L T D is recalling Franz Premium Pub Buns because they may contain undeclared soy.

    Product
    Franz Premium Pub Buns 12 pack, net wt. 32 oz., UPC 0-72220-70218-7
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2577-2018·2018-08-15

    Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure

    Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.

    Product
    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2686-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1752-2018·2018-08-15

    Whole Foods Bakery Products Recalled for Undeclared Soy Flour

    Whole Foods Market is recalling specific bakery products from Mid-Atlantic stores sold between May 25 and July 13 due to undeclared soy flour.

    Product
    CAKE PASSION FRUIT COCONUT 9IN
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1055-2018·2018-08-15

    Guardian Pharmacy Recalls EDTA Disodium Syringes for Sterility Concerns

    Guardian Pharmacy Services is recalling EDTA Disodium 30 mg/mL pre-filled syringes due to a lack of sterility assurance. The product was distributed in Texas.

    Product
    EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2685-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1056-2018·2018-08-15

    Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1052-2018·2018-08-15

    Guardian Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 4,900 vials of Ascorbic Acid 500 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2738-2018·2018-08-15

    Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing

    Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.

    Product
    The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1073-2018·2018-08-15

    Guardian Pharmacy Recalls Phenol 6% Injection Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 40 vials of Phenol 6% with Glycerin Injection in Texas due to a lack of sterility assurance.

    Product
    Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1759-2018·2018-08-15

    Grizzlies Granolas Oregon Trail Mix Recalled for Undeclared Milk

    Green Valley Group is recalling Grizzlies Granolas Oregon Trail Mix due to undeclared milk. The product was distributed in Idaho, Illinois, Oregon, and Washington.

    Product
    Grizzlies Brand and Grizzlies Granolas Oregon Trail Mix consisting of chocolate chips, fruit, seeds, and nuts. Product packaged in a cardboard box with a liner bag, net wt. 20 lbs., and was distributed to retailers for sale from their bulk bins. The product's…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1067-2018·2018-08-15

    Guardian Pharmacy Recalls Cefazolin Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling Cefazolin 2 Gm/20 mL syringes in Texas due to a lack of sterility assurance.

    Product
    Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1745-2018·2018-08-15

    Whole Foods Recalls Lemon Raspberry Cake for Undeclared Soy

    Whole Foods Market is recalling Lemon Raspberry Cake made in Mid-Atlantic stores because it failed to declare soy flour as an ingredient.

    Product
    CAKE LEMON RASPBERRY
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2552-2018·2018-08-15

    Vyaire Medical Recalls AirLife Adult Resuscitation Devices Due to Airflow Obstruction

    Vyaire Medical is recalling 15,714 AirLife Adult Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.

    Product
    AirLife Resuscitation Device, Adult labeled as the following: a. Adult, with mask, oxygen reservoir bag, Part Number 2K8004; b. Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve, Part Number 2K8035C2; c. Adult, with mask, 28" large bore tubing, Part…
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Drugs)·D-1039-2018·2018-08-15

    NuCare Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    NuCare Pharmaceuticals is recalling Valsartan/HCTZ 320/25mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4183-3
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-1753-2018·2018-08-15

    Utz Recalls Barbeque Potato Chips Due to Undeclared Soy Allergen

    Utz Quality Foods is voluntarily recalling specific expiration dates of Carolina Style Barbeque Potato Chips because they contain undeclared soy.

    Product
    utz Carolina Style Barbeque Potato Chips, Net Wt 2.875 OZ, UTZ Quality Foods, LLV, Hanover, PA 17301, UPC: 0-41780-00153-5; utz Carolina Style Barbeque Potato Chips, Net Wt 7.5 OZ; UTZ Quality Foods, LLV, Hanover, PA 17301; UPC: 0-41780-00049-1
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-1740-2018·2018-08-15

    Whole Foods Recalls Vanilla Panibois for Undeclared Soy Flour

    Whole Foods Market is recalling specific vanilla Panibois dessert shells sold in the Mid-Atlantic region because they failed to declare soy flour as an ingredient.

    Product
    CANDY DESSERT SHELL VANILLA PANIBOIS, 17 Ounce
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1748-2018·2018-08-15

    Whole Foods Bakery Products Recalled for Undeclared Soy Flour

    Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CAKE VANILLA SINGLE LAYER QUARTER SHEET, 88 Ounce
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2734-2018·2018-08-15

    Waterpik Sonic-Fusion Professional Recall Due to Charging Base Overheating

    Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.

    Product
    Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1053-2018·2018-08-15

    Guardian Pharmacy Recalls Ascorbic Acid TPN Bags Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 5,000 bags of Ascorbic Acid 500 mg/mL TPN in Texas due to lack of sterility assurance.

    Product
    Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1072-2018·2018-08-15

    Guardian Pharmacy Recalls MIC B Combo Lipotropic Vials for Sterility Concerns

    Guardian Pharmacy Services is recalling 250 vials of MIC B Combo Lipotropic in Texas due to a lack of sterility assurance.

    Product
    MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·18205·2018-08-15

    Xtava Recalls Allure Hair Dryers Due to Fire and Burn Hazards

    Xtava is recalling approximately 235,000 Allure and Allure Pro hair dryers because the units and power cords can overheat, catch fire, or cause electrical shock.

    Product
    Allure and Allure Pro hair dryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1126-2018·2018-08-15

    World Organix Recalls Kratom and CBD Capsules for Microbial Contamination

    World Organix LLC is recalling Blissful Remedies Kratom+CBD capsules due to potential high microbial loads. The affected products were distributed nationwide.

    Product
    Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas Nevada UPC# 7 11583 27057 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2717-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.

    Product
    rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1741-2018·2018-08-15

    Whole Foods Bakery Products Recalled for Undeclared Soy Flour

    Whole Foods Market is recalling various bakery products from Mid-Atlantic stores sold between May 25 and July 13 due to undeclared soy flour.

    Product
    CAKE BERRY CHANTILLY 6 IN, 41 Ounce
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2703-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1761-2018·2018-08-15

    Kraft Heinz Recalls Taco Bell Salsa Con Queso Due to Botulism Risk

    Kraft Heinz is recalling Taco Bell Salsa Con Queso Mild jars nationwide due to a risk of Clostridium botulinum growth.

    Product
    Taco Bell Salsa Con Queso Mild 15oz retail jar UPC 21000024490 packaged in 12 count and 8 count cases
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1746-2018·2018-08-15

    Whole Foods Recalls Mango Cake Mousse for Undeclared Soy Flour

    Whole Foods Market is recalling mango cake mousse products from Mid-Atlantic stores sold between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CAKE MOUSSE MANGO 6IN
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1750-2018·2018-08-15

    Whole Foods Recalls Banana Parfait for Undeclared Soy Flour

    Whole Foods Market is recalling 1,872 units of 1.0-pound Banana Parfaits made in Mid-Atlantic stores because they failed to declare soy flour as an ingredient.

    Product
    PARFAIT BANANA, 1.0 Pound
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2721-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1048-2018·2018-08-15

    Longbow Recalls Emergency First Aid Eyewash Due to Manufacturing Deviations

    Longbow First Aid Products Manufactory is recalling 30,000 bottles of Emergency First Aid Eyewash due to CGMP deviations. The product was distributed in New York and California.

    Product
    Emergency First Aid Eyewash (Purified Water 98.3%), packaged in a) 4fl oz. (118 ml) NDC 7110500002, and b) 0.67 fl (20 ml) NDC 71150000) bottles, Manufactured for: Redicare LLC, Congers, NY
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1057-2018·2018-08-15

    Guardian Pharmacy Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    Guardian Pharmacy Services is recalling 100 syringes of compounded Glycopyrrolate 0.2 mg/mL in Texas due to a lack of sterility assurance.

    Product
    Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2725-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V538000·2018-08-15

    Spartan K2 Chassis Recalled for Park Brake Defect

    Spartan Motors is recalling 2018-2019 K2 vehicles because the park brake may fail to hold the vehicle on a grade, increasing crash risk.

    Product
    SPARTAN — SPARTAN K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1829-2018·2018-08-15

    Seattle Sourdough Pub Buns Recalled for Undeclared Soy

    Portland French Bakery L T D is recalling Seattle Sourdough Pub Buns because they may contain undeclared soy.

    Product
    Seattle Sourdough Pub Buns 6 pack, net wt. 16 oz., UPC 0-72220-10164-5
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1734-2018·2018-08-15

    Whole Foods Recalls Fresh Peach Parfait for Undeclared Soy

    Whole Foods Market is recalling Fresh Peach Parfait sold in Mid-Atlantic stores because the product failed to declare soy flour as an ingredient.

    Product
    Fresh Peach Parfait , 1.0 Pound
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1737-2018·2018-08-15

    Whole Foods Bakery Products Recalled for Undeclared Soy Flour

    Whole Foods Market is recalling bakery products sold in the Mid-Atlantic region between May 25 and July 13 because they failed to declare soy flour as an ingredient.

    Product
    CUPCAKE MANGO WHITE CHOCOLATE MEDIUM EA , 4.0 Ounce
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2663-2018·2018-08-15

    Stryker rHead Radial Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 211 Stryker rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 285 rHead Stem Implant Plasma Coated, Size 2 units because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1791-2018·2018-08-15

    Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella Risk

    Pepperidge Farm is recalling specific Goldfish crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.

    Product
    Pepperidge Farm Goldfish Baked Snack Crackers Flavor Blasted Slammin Sour Cream & Onion. Net Wt. 6.6 oz. (187g) bag, UPC 14100-09480.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1818-2018·2018-08-15

    Flowers Foods Recalls Captain John Derst's Bread Due to Salmonella Risk

    Flowers Foods is recalling Captain John Derst's Good Old Fashioned Bread due to potential salmonella contamination in a whey powder sub-ingredient.

    Product
    Captain John Derst's Good Old Fashioned Bread***NET WT 20 OZ (1 LB 4 OZ) 567 g***Nutrition Facts 22 servings per container*** Calories 80***INGREDIENTS:UPC 071316001180***INGREDIENTS: ENRICHED FLOUR, MALTED BARLEY, FLOUR, NIACIN, REDUCED IRON*** DISTRIBUTED BY FLOWERS BAKERIES…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2018·2018-08-15

    Natus Neurology Recalls ErgoJust Video Carts Due to Pole Failure Risk

    Natus Neurology is recalling 797 ErgoJust mobile video carts because a manufacturing defect may cause the video pole to fail.

    Product
    Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For PTZ Video Ext, IP PTZ HD ErgoJust Video Extension, EuroJust ICU Cart Export For PTZ Video Ext. Video cart used for mobile medical record documentation.
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-2666-2018·2018-08-15

    Stryker Radial Stem Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics is recalling 280 Stryker rHead Radial Stem Implants because literature reviews show higher revision rates than similar devices.

    Product
    Lateral Assembly, Radial Stem Implant, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1817-2018·2018-08-15

    Flowers Foods Recalls Swiss Rolls Due to Potential Salmonella

    Flowers Foods is recalling Swiss Rolls snack cakes sold under multiple brands due to potential salmonella contamination in a whey powder ingredient.

    Product
    Swiss Rolls***Brand Name**Swiss Rolls Chocolate (Snack) Cakes, NET WT OZ (g) PKGS***TWIN PACKS***Nutrition Facts***Ingredients: SUGAR, WHEY (MILK), ENRICHED BLEACHED FLOUR***DISTRIBUTED BY***UPC Sold under the brand names... Mrs. Freshley's - NET WT 12 OZ (340g) 6-2 OZ…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2727-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 544 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2018·2018-08-15

    Howmedica Recalls 546 Bipolar Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 546 sterile bipolar radial head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #4 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1793-2018·2018-08-15

    Pepperidge Farm Goldfish Crackers Recalled for Potential Salmonella

    Pepperidge Farm is recalling specific Goldfish Baked Snack Crackers because an ingredient supplier reported potential Salmonella in the whey powder used in the seasoning.

    Product
    Pepperidge Farm Goldfish Baked Snack Crackers, 20 Packs Variety Pack. Containing 10 Colors Packs, and 10 Flavor Blasted Xtra Cheddar Packs. Net Wt. 18 oz. (1.1 lbs) (510g) UPC 14100-04720.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2726-2018·2018-08-15

    Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate

    Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead, Radial Implant 6 mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2018·2018-08-15

    Howmedica Radial Head Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2661-2018·2018-08-15

    Arjohuntleigh Q-Connect Scale Recall Due to Spreader Bar Detachment Risk

    Arjohuntleigh Magog is recalling Q-Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.

    Product
    Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1763-2018·2018-08-15

    Vitale Brothers Rye Bread Recalled for Undeclared Wheat

    Vitale Brothers Bakery is recalling 21 loaves of Rye bread sold in Michigan due to undeclared wheat, posing a risk to individuals with wheat allergies.

    Product
    Vitale Brothers Rye bread (1lb loaf) UPC1589410007
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2683-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 305 units of the rHead Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2018·2018-08-15

    Boston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation

    Boston Scientific is recalling Guider Softip XF Guide Catheters due to potential polymer material degradation. The recall affects 31,005 units distributed in the US and Canada.

    Product
    Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2696-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.

    Product
    Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2672-2018·2018-08-15

    Howmedica Recalls Radial Head Implant Due to Higher Revision Rate

    Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2715-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 90 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant non-coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 283 Stryker rHead Radial Head implants because literature suggests a higher revision rate than similar devices.

    Product
    Lateral Assembly, Radial Head Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1075-2018·2018-08-15

    Mylan Recalls Dymista Nasal Spray Due to Potential Glass Contamination

    Mylan Pharmaceuticals is recalling 20,780 bottles of Dymista nasal spray because glass fragments may be present in the neck area of the bottles.

    Product
    DYMISTA — DYMISTA (AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2699-2018·2018-08-15

    Howmedica Recalls Radial Head Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.

    Product
    Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Size 4

    Howmedica Osteonics Corp. is recalling 256 units of the rHead Stem Implant 6mm Collar, Size 4, because the revision rate is higher than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, Size 4.Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants

    Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.

    Product
    #3 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2669-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 230 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 170 Radio Capitellum Large, Left orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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