The Recall Desk

Archive

June 2018 recalls

577 recalls were announced in June 2018.

What the numbers show

Critical
17
Severe
142
High
282
Moderate
123
Low
13

Of the 577 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

201–300 of 577

  • HighFDA (Devices)·Z-2198-2018·2018-06-20

    Angiodynamics Recalls BioFlo Midline Kits Due to Bacterial Endotoxins

    Angiodynamics Inc. is recalling BioFlo Midline kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2190-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2185-2018·2018-06-20

    Roche Recalls Accu-Chek Aviva Plus Test Strips Due to Potential Errors

    Roche Diabetes Care is recalling specific lots of Accu-Chek Aviva Plus test strips because they may produce biased results or fail to detect blood, potentially leading to incorrect user actions.

    Product
    Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sug
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2018·2018-06-20

    Angiodynamics Recalls RS TANDEM 5F DL BIOFLO PASV Catheters

    Angiodynamics Inc. is recalling 20 boxes of RS TANDEM 5F DL BIOFLO PASV catheters because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M232242
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2148-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2157-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 2 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR, FILTER, PEEP VALVE, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1126FPC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2206-2018·2018-06-20

    Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling TANDEM 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2209-2018·2018-06-20

    Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins

    Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.

    Product
    RS 5F DL BIOFLO PASV, Catalog Number 60M161567
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Drugs)·D-0843-2018·2018-06-20

    RIJ Pharmaceutical Recalls Preferred Plus Pharmacy Antacid Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid because a water sample used in manufacturing showed an out-of-specification total aerobic microbial count.

    Product
    Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2184-2018·2018-06-20

    CellaVision DM Software Recall for LIS Data Transmission Malfunction

    Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.

    Product
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2165-2018·2018-06-20

    BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.

    Product
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differe
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0870-2018·2018-06-20

    MBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products

    MBi Nutraceuticals is voluntarily recalling Stomach Calm and other homeopathic products due to inadequate manufacturing controls.

    Product
    Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl. oz., liquid 8 ounce amber PET bottle with Black CRC Cap, MBi Nutraceuticals Lindon, UT 84042. Bar Code: 3 58301 38414 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1576-2018·2018-06-20

    Yukon Jackson Recalls Herd of Turtles Milk Chocolate for Allergen Labeling Error

    Yukon Jackson is recalling Herd of Turtles milk chocolate because pecans are listed in the ingredients but missing from the 'Contains' statement.

    Product
    Herd of Turtles confection milk chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89004 3. UPC of 8 oz: 6 55974 89008 1. The label is read in parts: "***INGREDIENTS: MILK CHOCOLATE 35% (SUGAR, COCOA BUTTER, WHOLE MILK POWDER, EMULSIFIER, SOYA LECITHIN, VANILLA), C
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2137-2018·2018-06-20

    Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure

    Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.

    Product
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Drugs)·D-0844-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Contamination

    RIJ Pharmaceutical LLC is recalling RPC Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2164-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorga
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2142-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recalled for Missing Warning Statements

    Philips is recalling 7,178 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2172-2018·2018-06-20

    BioMérieux Recalls Oxidase Reagent Due to Temperature Excursion in Guadeloupe

    BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.

    Product
    Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorgan
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2171-2018·2018-06-20

    BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

    BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in sol
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2183-2018·2018-06-20

    Zimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error

    Zimmer Biomet is recalling 169 Vanguard Knee System PS Tibial Bearings because the label master file was incorrectly set up, though the physical product is correctly marked.

    Product
    Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2018·2018-06-20

    BioMerieux VITEK 2 ANC Card Recalled Due to Temperature Excursion

    BioMerieux is recalling VITEK 2 ANC identification cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0874-2018·2018-06-20

    BioDiagnostic International Recalls Monsel's Solution for CGMP Deviations

    BioDiagnostic International is recalling 1,000 boxes of Monsel's Solution (Ferric Subsulfate) 20% because the product was not manufactured under current good manufacturing practices.

    Product
    Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2018·2018-06-20

    MBi Recalls Homeopathic Products Due to Manufacturing Control Deficiencies

    MBi Distributing Inc. is voluntarily recalling several homeopathic products, including Argentum Elixir, due to a lack of adequate manufacturing controls.

    Product
    Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz. amber PET bottle with white sprayer. MBi nutraceuticals Lindon UT, 84042. Bar COde: 3 58301 18114 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0867-2018·2018-06-20

    MBi Homeopathic Teething Drops Recalled for Lack of Manufacturing Controls

    MBi Nutraceuticals is voluntarily recalling homeopathic teething drops and other products due to a lack of adequate controls during manufacturing.

    Product
    Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2018·2018-06-20

    RIJ Pharmaceutical Recalls Antacid Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Preferred Plus Pharmacy Antacid Extra Strength due to out-of-specification microbial counts in a water sample.

    Product
    Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0850-2018·2018-06-20

    Geritrex Senna Syrup Recalled for Microbial Contamination

    RIJ Pharmaceutical LLC is recalling Geritrex Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0868-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Nausea Drops Due to Manufacturing Controls

    MBi Nutraceuticals is voluntarily recalling Nausea Drops and other homeopathic products due to a lack of adequate manufacturing controls.

    Product
    Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General Nausea, 1 Fl. Ounce amber glass bottle with glass dropper. MBi Nutraceuticals Lindon, UT 84042. Bar Code: 1 58301 04711 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2167-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.

    Product
    The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2162-2018·2018-06-20

    Keystone Dental Recalls Mislabeled Prima Plus Dental Implants

    Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.

    Product
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and termina
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2168-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0848-2018·2018-06-20

    GeriCare Senna Syrup Recalled for Microbial Contamination

    RIJ Pharmaceutical LLC is recalling GeriCare Senna Syrup due to out-of-specification microbial counts in a water sample.

    Product
    GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2169-2018·2018-06-20

    BioMérieux Recalls VIDAS TOXO IgG Avidity Test Due to Temperature Excursion

    BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.

    Product
    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). T
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0871-2018·2018-06-20

    MBi Homeopathic Expectorant Cough Syrup Recalled for Lack of Processing Controls

    MBi Nutraceuticals is voluntarily recalling Expectorant Cough Syrup and other homeopathic products due to inadequate manufacturing controls.

    Product
    Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET bottle with black cap. MBi Nutraceuticals 211 N 1800 W, Lindon, UT 84042. Bar Code: 3 58301 08214 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0852-2018·2018-06-20

    RIJ Recalls Gericare Diocto Liquid Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Gericare Diocto Liquid because a water sample showed an out-of-specification total aerobic microbial count.

    Product
    Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1578-2018·2018-06-20

    Yukon Jackson Coffee Toffee Recalled for Missing Pecan Allergen Labeling

    Yukon Jackson is recalling Coffee Toffee because pecans are listed in the ingredients but not in the 'Contains' statement.

    Product
    Coffee Toffee - 4 oz. packages. UPC 6 55974 89001 2. The label is read in parts: "***Ingredients: butter (milk), sugar, bittersweet chocolate 60% (cocoa liquor, emulsifier, soya lecithin, vanilla), coffee, pecans *** Contains: milk & soya ***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1577-2018·2018-06-20

    Yukon Jackson Recalls Herd of Turtles Dark Chocolate for Allergen Labeling Error

    Yukon Jackson is recalling Herd of Turtles dark chocolate because pecans are listed in ingredients but not in the 'Contains' statement.

    Product
    Herd of Turtles confection dark chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89005 0. UPC of 8 oz: 6 55974 89007 4. The label is read in parts: "***INGREDIENTS: BITTERSWEET CHOCOLATE 60% (COCOA LIQUOR, SUGAR, EMULSIFIER, SOYA LECITHIN, VANILLA) ***CARAMEL (SU
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0846-2018·2018-06-20

    RIJ Pharmaceutical Recalls Gericare Acetaminophen Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Gericare Liquid Pain Relief Acetaminophen due to out-of-specification microbial counts in a water sample.

    Product
    Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0869-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Drops Due to Manufacturing Control Deficiencies

    MBi Nutraceuticals is voluntarily recalling several homeopathic products, including Intestinal Colic Drops, due to a lack of adequate controls during manufacturing.

    Product
    Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle with glass dropper, liquid, Meteorism, and Porphyrinuria. MBi Nutraceuticals Lindon, UT 84042
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0853-2018·2018-06-20

    RIJ Recalls Gericare Iron Supplement Elixir Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling Gericare Iron Supplement Elixir due to out-of-specification microbial counts in a water sample.

    Product
    Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0873-2018·2018-06-20

    MBi Nutraceuticals Recalls Homeopathic Teething and Nausea Drops

    MBi Nutraceuticals is voluntarily recalling several homeopathic products, including teething and nausea drops, due to a lack of adequate manufacturing controls.

    Product
    Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white sprayer. MBi Nutraceuticals Lindon, Utah 84042 USA. Bar Code: 3 58301 18118 9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0849-2018·2018-06-20

    RIJ Pharmaceutical Recalls Ritussin DM Due to Microbial Count Deviation

    RIJ Pharmaceutical is recalling 9,240 bottles of Ritussin DM because a water sample showed an out-of-specification total aerobic microbial count.

    Product
    Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0851-2018·2018-06-20

    RIJ Pharmaceutical Recalls Senna Syrup Due to Microbial Count Deviation

    RIJ Pharmaceutical LLC is recalling Senna Syrup (Sennosides A and B) due to an out-of-specification total aerobic microbial count in a water sample.

    Product
    SENNA SYRUP — SENNA SYRUP (SENNOSIDES A AND B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0845-2018·2018-06-20

    RIJ Pharmaceutical Recalls Children's Acetaminophen Elixir Due to Microbial Count

    RIJ Pharmaceutical LLC is recalling 1,272 bottles of RPC Children's Non-Aspirin Elixir due to out-of-specification microbial counts in a water sample.

    Product
    RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2163-2018·2018-06-20

    Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect

    Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.

    Product
    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0847-2018·2018-06-20

    RIJ Pharmaceutical Recalls Acetaminophen Elixir Due to Microbial Count

    RIJ Pharmaceutical is recalling 228 bottles of RPC APAP Elixir due to out-of-specification microbial counts in a water sample.

    Product
    RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2018·2018-06-20

    BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion

    BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have b
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2140-2018·2018-06-20

    Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure

    Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.

    Product
    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Drugs)·D-0877-2018·2018-06-20

    Mylan Recalls Maxzide-25 Tablets Due to Slightly High Potency

    Mylan Pharmaceuticals is recalling 1,620 bottles of Maxzide-25 tablets because routine stability testing showed potency slightly above specification.

    Product
    Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18E042000·2018-06-19

    Bosch High Pressure Fuel Pump Recall for Fire Risk

    Bosch is recalling high pressure fuel pump assemblies for Ford and GM vehicles because welds may fracture, causing a fuel leak that could lead to a fire.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V413000·2018-06-19

    Forest River Recalls 2019 Prime Time Trailers Due to Stove Flame Hazard

    Forest River is recalling 2019 Prime Time recreational trailers because the stove is not isolated from the furnace return air, which can cause an inverted flame and increase the risk of injury.

    Product
    FOREST RIVER — FOREST RIVER PRIME TIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V414000·2018-06-19

    Forest River Prime Time Recalled for Incorrect Tire Pressure Label

    Forest River is recalling 2016-2018 Prime Time recreational trailers because the Federal Placard incorrectly states tire pressure as 65 PSI instead of 80 PSI.

    Product
    FOREST RIVER — FOREST RIVER PRIME TIME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·18V402000·2018-06-15

    Mazda Recalls Vehicles Due to Passenger Air Bag Inflator Explosion Risk

    Mazda is recalling specific 2003-2011 models because passenger air bag inflators may explode during deployment, potentially causing serious injury or death.

    Product
    MAZDA — MAZDA MPV, MAZDA6, RX-8, MAZDASPEED6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·18V404000·2018-06-15

    Mazda Recalls MPV and RX-8 Vehicles for Air Bag Inflator Defect

    Mazda is recalling 2005-2006 MPV and 2005-2009 RX-8 vehicles because the passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA MPV, RX-8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·18V403000·2018-06-15

    Mazda Recalls 2009-2010 RX-8 Vehicles for Air Bag Inflator Defect

    Mazda is recalling 2009-2010 RX-8 vehicles because the passenger air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA RX-8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V411000·2018-06-15

    Freightliner Recalls 2018-2019 Cascadia Trucks Due to Brake Caliper Bolt Issue

    Daimler Trucks North America is recalling 2018-2019 Freightliner Cascadia vehicles because brake caliper mounting bolts may not be properly tightened, potentially leading to reduced braking performance.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E041000·2018-06-15

    Simard Suspensions Recalls Front Axles Due to Wheel Detachment Risk

    Simard Suspensions is recalling certain front suspensions because heat from brakes may melt plastic insulators, causing wheels to detach and increasing crash risk.

    Product
    WHEELS:HUB recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V409000·2018-06-15

    Thomas Built Buses Recalls Saf-T-Liner EFX School Buses for Brake Defect

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner EFX school buses because an incorrectly plumbed check valve may cause sudden parking brake activation and increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V407000·2018-06-15

    Mercedes-Benz Recalls 2018 S-Class Vehicles for Electrical Fire Risk

    Mercedes-Benz is recalling 2018 S-Class and Maybach vehicles because improperly secured electrical power bars in the trunk may increase the risk of a fire or loss of vehicle functions.

    Product
    MERCEDES-MAYBACH — MERCEDES-MAYBACH, MERCEDES-BENZ S 560 4MATIC, S 650, S 450, S560
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V410000·2018-06-15

    2017-2018 Thomas Built Buses Saf-T-Liner EFX Air Brake Recall

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner EFX transit buses due to a check valve defect that may cause sudden parking brake activation and increase crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V408000·2018-06-15

    BMW Recalls G310R and G310GS Motorcycles for Side Stand Defect

    BMW is recalling 2017-2018 G310R and 2018 G310GS motorcycles because the side stand may damage the frame, causing the bike to fall over while stationary.

    Product
    BMW — BMW G310R, G310 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V405000·2018-06-15

    Mercedes-Benz Recalls 2018 GLA 250 for Missing Child Seat Anchor

    Mercedes-Benz is recalling 2018 GLA 250 vehicles because the center rear child seat tether anchor may be missing, preventing proper installation.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V397000·2018-06-14

    General Motors Recalls 2013 Chevrolet Volt for Propulsion Loss Risk

    General Motors is recalling 2013 Chevrolet Volt vehicles because a software update may disable cell balancing, causing a low-voltage condition that could lead to a loss of propulsion and increased crash risk.

    Product
    CHEVROLET — CHEVROLET VOLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E040000·2018-06-14

    Dexter Ventline Recalls LP Bottle Straps for Insufficient Crimping

    Dexter Ventline is recalling specific LP bottle straps because insufficient crimping may allow the buckle to detach. This could cause the propane tank to fall from the trailer, creating a road hazard.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V396000·2018-06-14

    Dodge Journey Recall: Rear Camera View May Be Delayed

    Chrysler is recalling 2018 Dodge Journey vehicles because the rear camera view may not appear within two seconds of selecting reverse, increasing crash risk.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·050-2018·2018-06-14

    Winter Sausage Manufacturing Recalls Poultry and Meat Products for Misbranding

    Winter Sausage Manufacturing Co. is recalling poultry, pork, and beef products because religious exemption slaughter was not declared on the labels.

    Product
    Winter Sausage Manufacturing Company Inc. — Winter Sausage Manufacturing Co. Recalls Poultry and Meat Products due to Misbranding
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1595-2018·2018-06-13

    Melanie Mini Cookies with Caramel Flavor Recalled for Undeclared Peanuts

    Desly International Corp. is recalling Melanie Mini Cookies with Caramel Flavor because the products contain undeclared peanuts.

    Product
    Melanie Mini Cookies with Caramel Flavor in a 17.6 oz (500g) clear plastic package with UPC 4770049082126.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-1594-2018·2018-06-13

    Desly International Recalls Melanie Liubitelskie Cookies Due to Undeclared Peanuts

    Desly International Corp. is recalling Melanie Liubitelskie Cookies because they contain undeclared peanuts. The recall affects 250 cases distributed across 21 states.

    Product
    Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plastic package with UPC 4770049011188.
    Category
    Food
    Distribution
    21 states
  • CriticalFDA (Food)·F-1537-2018·2018-06-13

    Zoe's Cookies Vegan Tuxedo Fudge Recalled for Undeclared Walnuts

    Dough-To-Go Inc is recalling Zoe's Cookies Vegan Tuxedo Fudge because the product contains undeclared walnuts, a major food allergen.

    Product
    Zoe's Cookies Vegan Tuxedo Fudge, 4 oz. (153 kg) individually wrapped cookie. INGREDIENTS: UNBLEACHED FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, ENZYME, FOLIC ACID), EVAPORATED CANE JUICE, VEGAN WHITE CHOCOLATE CHIPS (NON-BONE CHAR PROCESSED SUGAR, V
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1536-2018·2018-06-13

    FDA Recalls Ethanol Extraction 190 Proof Grain Alcohol Due to Methanol Contamination

    Lake Michigan Distilling is recalling 190 Proof Non-Denatured Grain Alcohol due to methanol contamination that could cause serious injury or death if consumed.

    Product
    Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, Multiple sizes: 8 oz, 16 oz, 32 oz, 64 oz, 1 gal, 2.5 gals, 5 gals, 55 gallon drum, 8oz clear PVC cylinder bottles, all others heavy-duty polyethylene bottles (except single 55-gallon plastic drum).
    Category
    Food
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2130-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0906-2018·2018-06-13

    Hospira Recalls Naloxone Hydrochloride Injection Due to Particulate Matter

    Hospira is recalling Naloxone Hydrochloride Injection cartridges due to the presence of particulate matter on the syringe plunger.

    Product
    NALOXONE HYDROCHLORIDE — NALOXONE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V406000·2018-06-13

    Volkswagen Recalls 2003 Models for Air Bag Inflator Defect

    Volkswagen is recalling 2003 EuroVan, Jetta, Passat, and Golf vehicles because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN EUROVAN, JETTA, PASSAT, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2125-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific Rival Reduce Fracture Plating and Rival View Plating System box plates because locking screws failed to properly engage during surgery.

    Product
    Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1538-2018·2018-06-13

    KUIYI International Recalls XZB Grilled Crispy Shrimp for Nitrofurans

    KUIYI International Inc. is recalling XZB Grilled Crispy Shrimp because the product tested positive for nitrofurans. The recall affects 399 cartons distributed in California.

    Product
    XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V388000·2018-06-13

    Porsche Recalls 2017-2018 Panamera Models Due to Rear Suspension Defect

    Porsche is recalling 715 Panamera vehicles because rear anti-roll bar links may detach, potentially affecting handling and increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA TURBO S E-HYBRID, PANAMERA 4S EXECUTIVE, PANAMERA TURBO SPORT TURI, PANAMERA 4S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2131-2018·2018-06-13

    Orthofix Recalls MTP Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling specific MTP plates because locking screws failed to properly engage during surgery.

    Product
    MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2126-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2134-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating Systems and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2122-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), b) D 2.7MM X 10MM (002-E-27010); c) D 2.7MM X 12MM (002-E-27012); d) D 2.7MM X 14MM (002-E-27014); e) D 2.7MM X 16MM (002-E-27016); f) D 2.7MM X 18MM (002-E-2
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2121-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws for Improper Plate Engagement

    Orthofix, Inc. is voluntarily recalling specific non-locking screws used in fracture plating systems because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008); b) D 2.7MM X 10MM (002-D-27010); c) D 2.7MM X 12MM (002-D-27012); d) D 2.7MM X 14MM (002-D-27014); e) D 2.7MM X 16MM (002-D-27016); f
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2132-2018·2018-06-13

    Orthofix Recalls Rival Fracture Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating and Rival View Plating Systems because locking screws failed to properly engage the plates during surgery.

    Product
    Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereUSDA FSIS·049-2018·2018-06-13

    HF Food Distributors Recalls Uninspected Sliced Cooked Ham Products

    HF Food Distributors is recalling approximately 142 pounds of sliced cooked ham produced without federal inspection. The products were shipped to Head Start centers in Puerto Rico.

    Product
    HF Food Distributors Recalls Pork Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1565-2018·2018-06-13

    Watan Dried Apricots Recalled for Undeclared Sulfites

    Global Commodities Inc. is recalling Watan Dried Apricots because they contain high levels of undeclared sulfites.

    Product
    WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH PITT, NET WT. 1 LB, and 0.50 LB, PRODUCE OF PAKISTAN, IMPORT BY: GLOBAL COMMODITIES INC. NEW YORK USA,
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2118-2018·2018-06-13

    Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2135-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture and View Plating Systems because locking screws failed to engage plates during surgery.

    Product
    Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
    Category
    Medical Device
    Distribution
    19 states
  • SevereUSDA FSIS·046-2018-EXP·2018-06-13

    Venda Ravioli Recalls Frozen Meat and Poultry Pasta Products

    Venda Ravioli, Inc. is recalling approximately 738 pounds of frozen meat and poultry pasta products produced without federal inspection. The products were shipped to retail locations in Rhode Island and Massachusetts.

    Product
    Venda Ravioli, Inc. Recalls Meat and Poultry Pasta Products Produced without Benefit of Inspection
    Category
    Food
    Distribution
    3 states

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