The Recall Desk

Archive

November 2016 recalls

802 recalls were announced in November 2016.

What the numbers show

Critical
61
Severe
132
High
403
Moderate
173
Low
33

Of the 802 recalls this month scored against our rubric, 8% are Critical, 16% are Severe.

Which agencies issued them

701–800 of 802

  • SevereFDA (Food)·F-0234-2017·2016-11-02

    Regalo Bakery Recalls Kababayan for Undeclared Allergens and Artificial Colorings

    Regalo Bakery is recalling Kababayan pastries because the product contains undeclared wheat, milk, soy, and artificial food colorings.

    Product
    Regalo Bakery: "Kababayan" [UPC#78253230920]: Packaged on a foam tray, containing six pieces, and wrapped in a clear plastic film. This product contains wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0235-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox Dairy because FDA environmental sampling found Listeria monocytogenes in the plant.

    Product
    OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0108-2017·2016-11-02

    Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0252-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Egg with Mushroom for Listeria Risk

    SM Fish Corp. is recalling Ossie's Egg with Mushroom due to potential Listeria monocytogenes contamination found during FDA environmental sampling.

    Product
    OSSIE'S EGG WITH MUSHROOM, NET WT. 7 OZ., UPC 73988570556; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0099-2017·2016-11-02

    Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk

    Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0233-2017·2016-11-02

    Regalo Bakery Recalls Taro Bread for Undeclared Allergens

    Regalo Bakery is recalling Taro Bread because it contains undeclared eggs, wheat, milk, soy, coconut, and artificial food coloring.

    Product
    Regalo Bakery: "Taro Bread" [UPC#78253231001] : Packaged in a clear plastic bag, containing twelve pieces, and have a net weight of 20 ounces This product contains This product contains: eggs, wheat, milk, soy, coconut, and artificial food coloring (Red 40 & 3, Yellow 5 & 6…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0098-2017·2016-11-02

    Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk

    Roche is recalling Modular Pre Analytics EVO/Plus systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0100-2017·2016-11-02

    Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports

    Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by the sharp edge of the sample rack tray.

    Product
    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0245-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Roman Shmaltz Herring Due to Listeria Risk

    SM Fish Corp. is recalling 92 units of Ossie's Roman Shmaltz Herring because FDA environmental sampling found Listeria monocytogenes in the plant.

    Product
    OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·17024·2016-11-02

    Midea Dehumidifiers Recalled Due to Fire and Burn Hazards

    GD Midea is recalling approximately 3.4 million dehumidifiers sold in the U.S. because they can overheat, smoke, and catch fire, posing serious fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0239-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Wasabi Herring Due to Listeria Risk

    SM Fish Corp. is recalling 65 units of Ossie's Wasabi Herring in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0248-2017·2016-11-02

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling 82 units of Ossie's Pickled Lox because FDA environmental sampling found Listeria monocytogenes in the facility.

    Product
    OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0232-2017·2016-11-02

    Regalo Bakery Recalls Balintawak for Undeclared Allergens

    Regalo Bakery is recalling Balintawak pastries because they contain undeclared eggs, wheat, milk, soy, and artificial food coloring.

    Product
    Regalo Bakery: "Balintawak" [UPC#78253203095] : Packaged on a foam tray, containing four pieces, wrapped in clear plastic film, and have a net weight of 16 ounces. This product contains: eggs, wheat, milk, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0095-2017·2016-11-02

    Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas e411 Immunoassay Analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0094-2017·2016-11-02

    Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge

    Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.

    Product
    Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0110-2017·2016-11-02

    Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk

    Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0106-2017·2016-11-02

    Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury

    Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail caused four reported injuries.

    Product
    cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0237-2017·2016-11-02

    SM Fish Corp. Recalls Herring for Potential Listeria Contamination

    SM Fish Corp. is recalling 106 units of Ossie's Taam Shabbos Herring due to potential Listeria monocytogenes contamination found during FDA environmental sampling.

    Product
    OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0104-2017·2016-11-02

    Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports

    Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.

    Product
    RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2017·2016-11-02

    Aesculap Safil Suture Recall Due to Needle Detachment Risk

    Aesculap is recalling 180 units of Safil QUI + UNDY 5/0 sutures because the needle may detach from the thread during surgery.

    Product
    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0314-2017·2016-11-02

    BBI Solutions Recalls SimpliRED D-Dimer Assay Kits Due to Performance Issues

    BBI Solutions is recalling SimpliRED D-Dimer assay kits because stability testing showed reduced sensitivity, which may cause false negative results and affect clinical decisions.

    Product
    SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·16V799000·2016-11-02

    Jeep Cherokee Recall for Driver Knee Air Bag Weld Defect

    Chrysler is recalling 2017 Jeep Cherokee vehicles because improper welds may prevent the driver's knee air bag from inflating properly.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2017·2016-11-02

    Nova Medical Recalls Journey Rolling Walkers Due to Loose Screws

    Nova Medical is recalling 1,380 Journey Rolling Walkers because screws holding the side supports can loosen and fall out.

    Product
    4205 Journey Rolling Walker Product Usage: used to assist people in walking
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0179-2017·2016-11-02

    Porfirio's Ricotta Gnocchi Recalled for Undeclared Wheat and Milk

    Porfirio's Homeade Ricotta Gnocchi is being recalled because it may contain undeclared wheat and milk allergens.

    Product
    Porfirio's Homeade Ricotta Gnocchi Net Wt. 16 oz (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0305-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq One Channel Infusers because a white screen during KVO titration may allow premature programming, potentially causing therapy delays and significant injury.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0114-2017·2016-11-02

    Sequent Medical Recalls VIA 27 Microcatheter Due to Re-sheathing Defect

    Sequent Medical is recalling 618 units of the VIA 27 Microcatheter because the device may not adequately re-sheath interventional devices as designed.

    Product
    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-0278-2017·2016-11-02

    Nestle Drumstick Ice Cream Recalled for Possible Listeria Contamination

    Nestle USA is voluntarily recalling specific Drumstick ice cream packs due to possible Listeria monocytogenes contamination from equipment contact surfaces.

    Product
    Nestle Drumstick Vanilla pack- 24x4.6fl oz US UPC# 72554-00160 Best Before Date: Between June 16 - June 19, 2017
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0184-2017·2016-11-02

    Porfirio's Jumbo Cheese Ravioli Recalled for Undeclared Wheat and Milk

    Porfirio's 12 Jumbo Cheese Ravioli is being recalled because it may contain undeclared wheat and milk allergens.

    Product
    Porfirio's 12 Jumbo Cheese Ravioli Net Wt. 14 oz. Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0103-2017·2016-11-02

    Roche VS II Aliquoter System recalled due to sharp edge injury risk

    Roche is recalling VS II Aliquoter System calculator modules because a sharp edge on the sample rack tray caused four reported injuries.

    Product
    VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0279-2017·2016-11-02

    Del Monte Recalls Mislabeled Lite Sliced Peaches Cans

    Del Monte is recalling cans of Lite Sliced Peaches that were mislabeled and actually contained Fruit Cocktail in Heavy Syrup. The product contains carmine, an ingredient that requires specific labeling.

    Product
    DM Light Slices Yellow Cling Peaches -15 oz (425g) 300 x 407
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0315-2017·2016-11-02

    Intuitive Surgical Recalls da Vinci Xi Systems Due to Software Anomaly

    Intuitive Surgical is recalling 677 da Vinci Xi Surgical Systems due to a software anomaly that may cause unexpected movement.

    Product
    da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0306-2017·2016-11-02

    Hospira Symbiq Infuser Recall for Potential White Screen Error

    Hospira is recalling Symbiq Two Channel Infusers because a white screen error during KVO titration could delay therapy and cause significant injury.

    Product
    Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2017·2016-11-02

    Lumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions

    Lumenis Limited is recalling 69 units of the FemTouch delivery system because the provided cleaning instructions may be ineffective for fully assembled devices, posing a risk of cross-contamination.

    Product
    FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·17026·2016-11-02

    Pier 1 Imports Recalls Glass Knobs Due to Laceration Hazard

    Pier 1 Imports is recalling approximately 140,000 glass knobs sold in the U.S. because they can break during use, posing a risk of laceration.

    Product
    Glass knobs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0357-2017·2016-11-02

    Wilton Blue Airbrush Color Recalled Due to Mold and Bacteria Contamination

    Wilton Brands is recalling 16,188 bottles of Blue Airbrush Color found to contain mold, yeast, or bacteria. The product was distributed nationwide in the U.S. and Canada.

    Product
    Wilton Blue Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0277-2017·2016-11-02

    Nestle Drumstick Ice Cream Recalled for Possible Listeria Contamination

    Nestle USA is voluntarily recalling specific Drumstick Club and Vanilla packs due to possible Listeria monocytogenes contamination from equipment contact surfaces.

    Product
    Nestle Drumstick Club variety - 16x4.6floz US UPC# 72554-11096 Best Before Date: Between June 2 - June 15, 2017
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0297-2017·2016-11-02

    AccessClosure Recalls PAXWIRE Occlusion Balloon System Due to Removal Risk

    AccessClosure, Inc. is voluntarily recalling the PAXWIRE Occlusion Balloon System because the device may be removed without a vascular sheath in place.

    Product
    The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0182-2017·2016-11-02

    Porfirio's 6 Cheese Manicotti Recalled for Undeclared Wheat and Milk

    Porfirio's 6 Cheese Manicotti is being recalled because it may contain undeclared wheat and milk, posing a risk to individuals with allergies.

    Product
    Porfirio's 6 Cheese Manicotti Net Wt. 22 oz. Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0113-2017·2016-11-02

    Persantine Tablets Recalled Due to Presence of Foreign 50 mg Tablets

    Boehringer Ingelheim is recalling 2,562 bottles of 75 mg Persantine tablets because 50 mg tablets were found inside the bottles.

    Product
    Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0186-2017·2016-11-02

    Porfirio's Cheese and Spinach Manicotti Recalled for Undeclared Allergens

    Porfirio's Italian Foods is recalling Cheese & Spinach Manicotti due to undeclared wheat and milk allergens. The product was distributed in New Jersey and Pennsylvania.

    Product
    Porfirio's Cheese & Spinach Manicotti Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0181-2017·2016-11-02

    Porfirio's Spinach Ravioli Recalled for Undeclared Wheat and Milk

    Porfirio's 12 Jumbo Spinach Ravioli is being recalled because it may contain undeclared wheat and milk allergens.

    Product
    Porfirio's 12 Jumbo Spinach Ravioli Net Wt. 14 oz. (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0185-2017·2016-11-02

    Porfirio's Egg Fettucine Recalled for Undeclared Wheat and Milk

    Porfirio's Italian Food, Inc. is recalling 1,400 lbs of Egg Fettucine due to undeclared wheat and milk allergens. The product was distributed in New Jersey and Pennsylvania.

    Product
    Porfirio's Egg Fettucine Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0183-2017·2016-11-02

    Porfirio's Stuffed Shells Recalled for Undeclared Wheat and Milk

    Porfirio's 12 Jumbo Stuffed Shells are being recalled because they may contain undeclared wheat and milk allergens.

    Product
    Porfirio's 12 Jumbo Stuffed Shells Net Wt. 24 oz. Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0178-2017·2016-11-02

    Porfirio's Potato Gnocchi Recalled for Undeclared Wheat and Milk

    Porfirio's Potato Gnocchi is being recalled because it may contain undeclared wheat and milk, posing a risk to consumers with allergies.

    Product
    Porfirio's Potato Gnocchi Net Wt. 16 oz. (1 LB.) 453 g Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ 08611 UPC 016105000319
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0180-2017·2016-11-02

    Porfirio's Ricotta Cavatelli Recalled for Undeclared Wheat and Milk

    Porfirio's Homeade Ricotta Cavatelli is being recalled because it may contain undeclared wheat and milk allergens.

    Product
    Porfirio's Homeade Ricotta Cavatelli Net Wt. 1Lb Manufactured by Porfirio's Italian Food, Inc. 320 Anderson Street, Trenton NJ
    Category
    Food
    Distribution
    2 states
  • HighCPSC·17025·2016-11-02

    Trek Recalls Farley Bicycles Due to Fork Separation Fall Hazard

    Trek Bicycle Corp. is recalling 2014 and 2015 Farley bicycles and framesets because the fork can separate from the steer tube, posing a fall hazard to the rider.

    Product
    Trek Farley bicycles and framesets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2017·2016-11-02

    Boehringer Ingelheim Recalls Dipyridamole Tablets Due to Foreign Tablet Presence

    Boehringer Ingelheim is recalling 6,400 bottles of 75 mg Dipyridamole tablets because 50 mg Persantine tablets were found inside the bottles.

    Product
    DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0302-2017·2016-11-02

    TEM Systems Recalls ex-TEM Assay Reagents Due to Low Vial Levels

    TEM Systems Inc is recalling ex-TEM Assay reagents for the ROTEM delta system because customers reported low or empty vials.

    Product
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM delta.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0261-2017·2016-11-02

    Pharmatech Recalls Polyvitamin Liquid with Iron Due to Potential Contamination

    Pharmatech LLC is recalling 201,784 bottles of Polyvitamin Liquid with Iron as a precautionary measure due to potential contamination with Burkholderia cepacia.

    Product
    Polyvitamin Liquid with Iron, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0259-2017·2016-11-02

    Pharmatech Recalls Ferrous Sulfate Liquid Due to Potential Contamination

    Pharmatech LLC is recalling 75,972 bottles of Ferrous Sulfate Liquid as a precautionary measure due to potential contamination with Burkholderia cepacia.

    Product
    Ferrous Sulfate Liquid, 16 oz./473 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0320-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 CMV IgM Assay kits due to reported increased imprecision and high coefficient of variation results.

    Product
    IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (US), SMN 10370302 (US), UDI 00630414985725 (US); and REF/Catalog Number L2KCM2 - 200 tests (OUS), SMN 10371320 (OUS), UDI 00630414961163 (OUS); IVD --- Siemens Healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0318-2017·2016-11-02

    Pentax Video Gastroscope Recall for Updated Operation and Reprocessing Instructions

    Pentax of America Inc is recalling video gastroscopes to provide customers with the most recent Operation and Reprocessing Instructions (IFUs).

    Product
    Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0254-2017·2016-11-02

    Pharmatech LLC Recalls Virtrate-2 Dietary Supplement Due to Contamination Risk

    Pharmatech LLC is recalling 34,612 bottles of Virtrate-2 dietary supplement due to a potential risk of contamination with Burkholderia cepacia.

    Product
    Virtrate-2, Sodium Citrate-Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0268-2017·2016-11-02

    Pharmatech Recalls D-Vita Drops Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling 90,504 bottles of D-Vita Drops dietary supplements due to a precautionary measure regarding potential contamination with Burkholderia cepacia.

    Product
    D-Vita Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0358-2017·2016-11-02

    Wilton Silver Airbrush Color Recalled for Potential Mold and Bacteria

    Wilton Brands is recalling 17,670 bottles of Silver Airbrush Color found to contain mold, yeast, or bacteria. The product was distributed nationwide in the U.S. and Canada.

    Product
    Wilton Silver Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0317-2017·2016-11-02

    Zimmer Biomet Recalls Patellofemoral Joint Prosthesis Milling Handpieces

    Zimmer Biomet is recalling 703 Patellofemoral Joint Prosthesis Milling Handpieces because they may be inoperable due to lack of preventative maintenance, potentially delaying surgery.

    Product
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0299-2017·2016-11-02

    Keystone Dental PrimaConnex Straight Implant Recall Due to Cover Screw Mismatch

    Keystone Dental Inc. is recalling 55 units of PrimaConnex Straight Implants because small diameter cover screws were packaged with regular diameter implants.

    Product
    Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0255-2017·2016-11-02

    Pharmatech Recalls Virtrate-K Dietary Supplement Due to Potential Contamination

    Pharmatech LLC is recalling 8,232 bottles of Virtrate-K dietary supplement due to a precautionary measure regarding potential Burkholderia cepacia contamination.

    Product
    Virtrate-K, Potassium Citrate and Citric Acid, 16oz./473 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0298-2017·2016-11-02

    TZ Medical Recalls Mis-Labeled Neptune Plus Hemostatic Pads

    TZ Medical is recalling Neptune Plus hemostatic pads because the labels incorrectly state they include an antimicrobial barrier.

    Product
    Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0275-2017·2016-11-02

    Pharmatech Recalls Renew HC Hydrolyzed Clinoptilolite Dietary Supplement

    Pharmatech LLC is recalling Renew HC dietary supplement bottles due to a precautionary measure regarding potential contamination with Burkholderia cepacia.

    Product
    Renew HC, Hydrolyzed Clinoptilolite, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0262-2017·2016-11-02

    Pharmatech Recalls Polyvitamin Liquid Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling Polyvitamin Liquid as a precautionary measure due to potential contamination with Burkholderia cepacia. The product was distributed in Florida, Michigan, Mississippi, and Ohio.

    Product
    Polyvitamin Liquid, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0258-2017·2016-11-02

    Pharmatech Recalls Cerovite Liquid Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling 129,268 bottles of Cerovite Liquid dietary supplement due to a precautionary measure regarding potential contamination with Burkholderia cepacia.

    Product
    Cerovite Liquid, 8 oz./236 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0271-2017·2016-11-02

    Pharmatech Recalls Pedia Tri-Vite Drops Due to Potential Contamination

    Pharmatech LLC is recalling 8,712 bottles of Pedia Tri-Vite Drops due to a potential risk of contamination with Burkholderia cepacia.

    Product
    Pedia Tri-Vite Drops, 50 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0319-2017·2016-11-02

    Siemens CMV IgM Assay Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling IMMULITE CMV IgM Assay kits due to reported increases in imprecision and high coefficient of variation (CV) values.

    Product
    IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Siemens Material Number (SMN) 10370301 (US), Unique Device Identification Number (UDI) 00630414985718 (US); and REF/Catalog Number LKCM1 - 100 tests (OUS); SMN 10381296 (OUS), UDI…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0281-2017·2016-11-02

    Bob's Red Mill Guar Gum Recalled for Misidentified Ingredient

    Bob's Red Mill is voluntarily recalling one lot of Guar Gum due to the inclusion of a misidentified ingredient, hydroxyethylcellulose.

    Product
    Label reads in part "*** Bob's Red Mill *** PREMIUM GUAR GUM SUPERB GLUTEN FREE THICKENER & BINDER *** NET WT 8 OZ ***" Product is packaged in multilayered flexible film with multiple colors. Firm brand name is printed in red. Case contains 8/8 oz. packages. UPC 0…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0356-2017·2016-11-02

    Wilton Black Airbrush Color Recalled for Mold, Yeast, or Bacteria

    Wilton Brands is recalling 16,446 bottles of Black Airbrush Color found to contain mold, yeast, or bacteria. The product was distributed nationwide in the U.S. and Canada.

    Product
    Wilton Black Airbrush Color, Net Wt 0.64 FL OZ (19 mL)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0276-2017·2016-11-02

    Pharmatech Recalls CytoDetox Supplement Due to Potential Bacterial Contamination

    Pharmatech LLC is recalling 1,990 bottles of CytoDetox dietary supplement due to a precautionary measure regarding potential contamination with Burkholderia cepacia.

    Product
    CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile. Dietary supplement.
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-0115-2017·2016-11-02

    Invokamet Recalled for Incorrect or Missing Package Insert Labeling

    Janssen Ortho L.L.C. is recalling Invokamet tablets because Xarelto prescribing information outserts may be affixed to the bottles instead of the correct Invokamet inserts.

    Product
    INVOKAMET — INVOKAMET (CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0312-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec AP Calibrator Due to Labeling Error

    Becton Dickinson is recalling 94 units of PhoenixSpec AP Calibrator because the expiration date year is incorrectly labeled on the kit.

    Product
    PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec & Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0313-2017·2016-11-02

    Ortho-Clinical Diagnostics Recalls VITROS HBsAg Controls Due to Performance Drift

    Ortho-Clinical Diagnostics is recalling VITROS HBsAg Controls because signal/cutoff results may increase during the 5-day reconstituted timeframe, potentially affecting performance monitoring.

    Product
    VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0311-2017·2016-11-02

    Becton Dickinson Recalls PhoenixSpec Calibrator Kits Due to Labeling Error

    Becton Dickinson is recalling specific lots of BBL PhoenixSpec Calibrator kits because the kits are labeled with an incorrect expiration year, although the individual tubes have correct dates.

    Product
    PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec &#38 Phoenix AP Instruments. The instruments are then used to measure the turbidity of microbial suspensions equivalent to McFarland standards 0.10 to 4.50.
    Category
    Medical Device
    Distribution
    17 states
  • SevereNHTSA·16V794000·2016-11-01

    Winnebago Recalls 2017 View and Navion Motorhomes for Seat Bolt Issue

    Winnebago is recalling 2017 View and Navion motorhomes because loose seat mounting bolts may allow seats to detach, increasing injury risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, NAVION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E082000·2016-11-01

    Omix Ada Recalls Replacement Steering Sector Shafts for Early Jeeps

    Omix Ada is recalling 344 replacement steering sector shafts for early Willys and Jeep vehicles due to incomplete heat treatment that may cause premature failure.

    Product
    STEERING:GEAR BOX:SHAFT SECTOR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V795000·2016-11-01

    Spartan Motors Recalls Transit Bus Chassis Cabs Due to Exhaust Fire Risk

    Spartan Motors is recalling 245 model year 2011-2017 Transit Bus Chassis Cabs because a disconnecting exhaust tube may expose the floor to high heat, increasing fire risk.

    Product
    SPARTAN MOTORS — SPARTAN MOTORS TRANSIT BUS CHASSIS CAB
    Category
    Vehicle
    Distribution
    Distributed nationwide

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