The Recall Desk

Archive

December 2017 recalls

389 recalls were announced in December 2017.

What the numbers show

Critical
38
Severe
74
High
172
Moderate
94
Low
11

Of the 389 recalls this month scored against our rubric, 10% are Critical, 19% are Severe.

301–389 of 389

  • SevereNHTSA·17V783000·2017-12-07

    Autocar Recalls 2017-2018 Xpeditor Vehicles for Fire Risk

    Autocar is recalling 2017-2018 Xpeditor vehicles because the HVAC defrost actuator may overheat, increasing the risk of a fire.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0473-2018·2017-12-06

    Yorgo's Foods Taboule Salad Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling Taboule Salad products in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    Yorgo's Foods TABOULE SALAD NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10057 5; Yorgo's Foods TABOULE SALAD NET WT 7 OZ (198.4g) UPC: 7 56248 10001 8; Yorgo's Foods TABOULE SALAD NET WT 14 OZ (397g) UPC: 7 56248 10007 0; Product is packaged in a clear plastic container, keep refrig
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0389-2018·2017-12-06

    Casa Sanchez Guacamole Recalled Due to Listeria monocytogenes Surveillance Finding

    FANTE, Inc. is recalling Casa Sanchez Foods Real Guacamole because FDA found Listeria monocytogenes in a surveillance sample. The product was distributed in California, Hawaii, and Nevada.

    Product
    Casa Sanchez Foods, Real Guacamole; Net Wt. 9 oz.. (255 g), 1/2 gallon UPC: 0 78732 00412 2; 78732 00431-3 ; 0-78732-00412-2 Ingredients: Avocados, tomatoes, cucumber, onions, pepper, lemon juice, sea salt, ascorbic acid and citric acid.
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0461-2018·2017-12-06

    Yorgos Foods Spinach and Artichoke Hummus Recalled for Listeria Risk

    Yorgos Foods is recalling Spinach & Artichoke Hommus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgos FOODS Spinach & Artichoke Hommus - UPC: 7 56248 10067 4. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0462-2018·2017-12-06

    Yorgos Foods Lemon Hommus Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling Lemon Hommus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgos FOODS Lemon Hommus UPC: 7 56248 10018 6. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0477-2018·2017-12-06

    Yorgo's Foods Sundried Tomato and Basil Hummus Recalled for Listeria

    Yorgo Food's Inc. is recalling Sundried Tomato and Basil Hummus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods SUNDRIED TOMATO and BASIL HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10031 5. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0457-2018·2017-12-06

    Yorgos Foods Recalls Original Hommus Due to Listeria Risk

    Yorgos Foods Inc. is recalling Original Hommus in various sizes because the product may be contaminated with Listeria monocytogenes.

    Product
    Yorgos FOODS Original Hommus 8 oz. (227g) UPC: 7 56248 10002 5 and 16 oz. (454g) UPC: 7 56248 10005 6; 32 OZ UPC: 7 56248 10010 0; NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10100 8. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0464-2018·2017-12-06

    Yorgo's Foods Recalls Cilantro and Chive Yogurt Dip for Listeria Risk

    Yorgo Food's Inc. is recalling Trader Joe's and Yorgo's Foods Cilantro & Chive Yogurt Dip due to potential Listeria monocytogenes contamination.

    Product
    TRADER JOE S CILANTRO & CHIVE YOGURT DIP¿NET WT 8 OZ (227g) UPC: 0078 7208 and Yorgo's Foods CILANTRO & CHIVE YOGURT DIP NET WT 8 OZ (227g) UPC: 7 56248 10049 0. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0467-2018·2017-12-06

    Yorgo's Foods Chickpea Salad Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling specific sizes of Chickpea Salad due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods CHICKPEA SALAD NET WT. 5 LBS 80 OZ (2268g) UPC: 7 56248 10068 1 and Yorgo's Foods CHICKPEA SALAD NET WT. 12 OZ (340g)UPC: 7 56248 10061 2. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0478-2018·2017-12-06

    Yorgo's Foods Party Tray Hummus Recalled for Listeria Contamination

    Yorgo's Foods is recalling Party Tray Original and Red Pepper Hummus due to potential Listeria monocytogenes contamination. The products were distributed in New York and New Jersey.

    Product
    Party Tray: Yorgo's Foods PARTY TRAY ORIGINAL HOMMUS NET WT. 32 OZ UPC: 7 56248 10097 1 and Yorgo's Foods PARTY TRAY RED PEPPER HOMMUS NET WT. 32 OZ UPC: 7 56248 10016 2. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0390-2018·2017-12-06

    Casa Sanchez Foods Recalls Spicy Guacamole Due to Listeria Risk

    FANTE, Inc. is recalling Casa Sanchez Foods Spicy Guacamole because FDA found Listeria monocytogenes in a surveillance sample.

    Product
    Casa Sanchez Foods, Spicy Guacamole; Net Wt. 9 oz.. (255 g) UPC: 0 78732 00426 9
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-0468-2018·2017-12-06

    Yorgo's Foods Chipotle Pepper Hummus Recalled for Listeria Risk

    Yorgo Food's Inc. is recalling Chipotle Pepper Hummus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods CHIPOLTE PEPPER HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10019 3. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0463-2018·2017-12-06

    Yorgo's Foods Baba Ghannouj Recalled for Listeria Contamination Risk

    Yorgo Food's Inc. is recalling Baba Ghannouj products in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    Yorgos FOODS Baba Ghannouj UPC: 7 56248 10006 3; Yorgo's Foods BABA GHANNOUJ NET WT. 16 OZ (454g) UPC: 7 56248 10006 3 - Product is packaged in a clear plastic container, keep refrigerated. Yorgo's Foods BABA GHANNOUJ NET WT. 5 LBS 80 oz (2268g)
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V781000·2017-12-06

    Audi Recalls 2012-2014 A6 and A7 Models for Fuel Line Fire Risk

    Volkswagen Group of America is recalling 2012-2014 Audi A6 and A7 vehicles because a weakening fuel line compression point can cause leaks and increase fire risk.

    Product
    AUDI — AUDI A6, A7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0476-2018·2017-12-06

    Yorgo's Foods Tzatziki Recalled for Listeria monocytogenes Contamination

    Yorgo Food's Inc. is recalling Tzatziki products in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    Yorgo's Foods TZATZIKI NET WT 8 OZ (227g) UPC: 7 56248 10053 7 and Yorgo's Foods TZATZIKI NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0460-2018·2017-12-06

    Yorgos Foods Green Olive Hummus Recalled for Listeria Contamination

    Yorgos Foods is recalling Green Olive Hummus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgos FOODS Green Olive Hommus NET WT 8 OZ (227g) UPC: 7 56248 10032 2. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0474-2018·2017-12-06

    Yorgo's Foods Recalls Three Bean Salad Due to Listeria Contamination

    Yorgo Food's Inc. is recalling specific sizes of Three Bean Salad because the product may be contaminated with Listeria monocytogenes.

    Product
    Yorgo's Foods THREE BEAN SALAD NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10071 1 and Yorgo's THREE BEAN SALAD NET WT. 12 OZ (340g) UPC: 7 56248 10063 6. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0465-2018·2017-12-06

    Yorgo's Tahini Sauce Recalled for Listeria Contamination Risk

    Yorgo Food's Inc. is recalling Tahini Sauce products due to potential Listeria monocytogenes contamination. The affected products were distributed in New York and New Jersey.

    Product
    Tahini Sauce: TRADER JOE S TAHINI SAUCE NET WT 8 OZ (227g) UPC: 0078 7239; Yorgo's Foods TAHINI SAUCE NET WT. 5 LBS 80 OZ (2268g)Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0471-2018·2017-12-06

    Yorgo's Foods Vegetable Hummus Recalled for Listeria Contamination

    Yorgo's Foods is recalling Vegetable Hummus in 8 oz and 5 lb containers due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods VEGETABLE HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10008 7 and Yorgo's Foods VEGETABLE HOMMUS NET WT. 5 LBS 80 OZ(2268g). Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0470-2018·2017-12-06

    Yorgo's Foods Garlic and Chive Hummus Recalled for Listeria Risk

    Yorgo Food's Inc. is recalling Garlic and Chive Hummus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods GARLIC AND CHIVE HOMMUS NET WT 8 OZ (227g) UPC: 7 56248 10034 6. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V780000·2017-12-06

    Starcraft Bus Prodigy and Quest School Bus Fuel Line Recall

    Forest River is recalling 2017 Starcraft Bus Prodigy and Quest school buses because floor screws may damage fuel lines, risking leaks, engine stalls, or fires.

    Product
    STARCRAFT BUS — STARCRAFT BUS QUEST, PRODIGY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V779000·2017-12-06

    Travel Lite Recalls 2018 Falcon Trailers Due to Underrated Hitch Coupler

    Travel Lite is recalling 2018 Falcon recreational trailers because an underrated hitch coupler was installed, which could cause the trailer to detach from the tow vehicle.

    Product
    TRAVEL LITE — TRAVEL LITE FALCON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0466-2018·2017-12-06

    Yorgo's Foods Black Bean Salad Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling specific sizes of Black Bean Salad due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods BLACK BEAN SALAD NET WT. 5 LBS 80 OZ (2268g) UPC: 7 56248 10069 and Yorgo's Foods BLACK BEAN SALAD NET WT. 12 OZ (340g)UPC: 7 56248 10062 9. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0459-2018·2017-12-06

    Yorgo's Foods Garlic Hommus Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling Garlic Hommus products in New York and New Jersey due to potential Listeria monocytogenes contamination.

    Product
    Yorgos FOODS Garlic Hommus 8 oz. (227g) UPC: 7 56248 10015 5 and 16 oz. (454g) UPC: 7 56248 10014 8. Yorgo's Foods GARLIC HOMMUS NET WT. 5 LBS 80 OZ (2268g) Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0101-2018·2017-12-06

    Zydus Recalls Paroxetine Tablets Due to Presence of Risperidone

    Zydus Pharmaceuticals is recalling Paroxetine tablets because Risperidone tablets were found in the bottles. Consumers should stop using the affected products.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0458-2018·2017-12-06

    Yorgos Foods Roasted Red Pepper Hummus Recalled for Listeria Contamination

    Yorgos Foods is recalling Roasted Red Pepper Hummus due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgos FOODS Roasted Red Pepper Hommus 8 oz. (227g) UPC: 7 56248 10016 2 and 16 oz. (454g) UPC: 7 56248 10017 9 and NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0421-2018·2017-12-06

    Ahold Recalls Frozen Sweet Corn Due to Listeria Test Results

    Ahold U.S.A. is recalling specific brands of frozen whole kernel sweet corn after a retail sample tested positive for Listeria monocytogenes.

    Product
    Ahold-Own Brands Whole Kernel Sweet Corn, 16 oz. Plastic Bag : Stop & Shop Brand Frozen Whole Kernel Sweet Corn, 16 oz. GIANT/MARTIN S Brand Frozen Whole Kernel Sweet Corn, 16 oz. Giant Brand Frozen Whole Kernel Sweet Corn, 16 oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0469-2018·2017-12-06

    Yorgo's Foods Falafel Recalled for Listeria monocytogenes Contamination

    Yorgo Food's Inc. is recalling Yorgo's Foods Falafel due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods FALAFEL NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0178-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device 2.5.8 Units

    Zimmer Biomet is recalling 22 ROSA Surgical Device 2.5.8 units due to an issue with the optional neuro-endoscopy module detected during internal testing.

    Product
    ROSA Surgical Device 2.5.8
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0171-2018·2017-12-06

    BD Phoenix PMIC-107 Panels Recalled Due to Quality Control Failures

    Becton Dickinson is recalling specific lots of BD Phoenix PMIC-107 panels due to manufacturing issues that may affect antibiotic susceptibility testing results.

    Product
    BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0403-2018·2017-12-06

    Ruckers Makin Batch Candies Recalls Dark Chocolate Products for Undeclared Milk

    Ruckers Makin Batch Candies is voluntarily recalling specific dark chocolate products due to undeclared milk, a common allergen.

    Product
    The Toothsome Chocolate Emporium Dark Chocolate Peanuts. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0174-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control Recalled for Inaccurate Ceruloplasmin Assignment

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control lots due to inaccurate ceruloplasmin assignment, which may cause patient results to fall below the reference range.

    Product
    Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0396-2018·2017-12-06

    Pure Encapsulations Systemic Enzyme Complex Recalled for Undeclared Sulfites

    Pure Encapsulations is recalling Systemic Enzyme Complex dietary supplements because they contain undeclared sulfites. The products were distributed in five states.

    Product
    Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0392-2018·2017-12-06

    Dark Chocolate Cashew Recalled for Undeclared Milk Allergen

    Dutch Valley Food Distributors is recalling Dark Chocolate Cashew because the supplier failed to declare milk as an allergen, resulting in missing label information.

    Product
    Dark Chocolate Cashew, Net 11 oz., Contains Cashew and Soy, Distributed By: Dutch Valley Food Distributors, Inc., Myerstown, PA 17067; UPC: 77245 00601; Lot#, Best By dates: 20160404, 04/14/17;
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0472-2018·2017-12-06

    Yorgo's Foods Grape Leaves Recalled for Listeria Contamination Risk

    Yorgo Food's Inc. is recalling grape leaves due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's Foods GRAPE LEAVES NET WT 8 OZ (227g) UPC: 7 56248 10004 9; Yorgo's Foods GRAPE LEAVES NET WT. 5 LBS 80 oz (2268g). Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0475-2018·2017-12-06

    Yorgo's Vegan Hoppin Salad Recalled for Listeria Contamination

    Yorgo Food's Inc. is recalling Yorgo's Vegan Hoppin Salad due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    Yorgo's VEGAN HOPPIN SALAD NET WT. 12 OZ (340g) UPC: 7 56248 10064 3. Product is packaged in a clear plastic container, keep refrigerated.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0407-2018·2017-12-06

    Wegmans Organic Dark Chocolate Covered Cranberries Recalled for Undeclared Milk

    First Source, LLC is recalling Wegmans Organic Dark Chocolate Covered Cranberries because the product contains undeclared milk. This poses a risk to consumers with milk allergies.

    Product
    Wegmans Organic Dark Chocolate Covered Cranberries NET WT 14 OZ (396g) UPC: 0 77890 37786 4, Product code 5546289
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0172-2018·2017-12-06

    Brainlab ExacTrac Vero Radiation Therapy System Recall for Positioning Error

    Brainlab is recalling ExacTrac Vero systems because a software error may cause the treatment couch to miss the planned position, potentially affecting radiation therapy accuracy.

    Product
    BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Rad
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0406-2018·2017-12-06

    First Source Recalls Organic Dark Chocolate Cherries Due to Undeclared Milk

    First Source, LLC is recalling specific lots of organic dark chocolate covered cherries because they contain undeclared milk, a major food allergen.

    Product
    Organic Dark Chocolate (Covered) Cherries: Wegmans Organic Dark Chocolate Cherries NET WT 14 OZ (396g), UPC: 0 77890 37785 7, Product code 5546290 and TOPS snacks Organic Dark Chocolate covered Cherries NET WT 13 OZ (368 g) UPC: 0 70784 50779 8, Product code 5541417
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0402-2018·2017-12-06

    Toothsome Chocolate Emporium Dark Chocolate Coffee Beans Recalled for Undeclared Milk

    Ruckers Makin Batch Candies is recalling Dark Chocolate Coffee Beans, Cranberries, and Peanuts due to undeclared milk allergen.

    Product
    The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0192-2018·2017-12-06

    Hill-Rom Recalls Monarch Airway Clearance Systems Due to EMI Risk

    Hill-Rom is recalling 60 Monarch Airway Clearance Systems because electromagnetic interference may disrupt implanted pacemakers or defibrillators.

    Product
    Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Control M Recalled for Inaccurate Ceruloplasmin Results

    Siemens Healthcare Diagnostics is recalling Dimension Vista Protein 1 Control M units because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2018·2017-12-06

    Volcano Imaging Systems Recalled Due to Unexpected Windows Security Dialog

    Volcano Corporation is recalling specific intravascular ultrasound imaging systems because an unexpected Microsoft Windows Security dialog may appear during use, potentially affecting device operation.

    Product
    Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0391-2018·2017-12-06

    Dark Chocolate Almond Recalled for Undeclared Milk Allergen

    Dutch Valley Food Distributors is recalling Dark Chocolate Almond products because the supplier failed to declare milk as an allergen, resulting in missing label information.

    Product
    Dark Chocolate Almond, Net 11 oz., Contains Almond and Soy, Distributed By: Dutch Valley Food Distributors, Inc., Myerstown, PA 17067; UPC: 77245 00605; Lot#, Best By dates: 20160512, 05/12/17; 20160609, 06/9/17; 20160811, 08/11/17; 20160923, 09/23/17; 20161115, 11/15/17; 2017
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0381-2018·2017-12-06

    GourmetNut Dark Chocolate Covered Almonds Recalled for Undeclared Milk

    Gourmet Nut, Inc. is recalling Dark Chocolate Covered Almonds because the product contains undeclared milk, posing a risk to consumers with milk allergies.

    Product
    GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0405-2018·2017-12-06

    First Source Recalls Organic Dark Chocolate Covered Raisins for Undeclared Milk

    First Source, LLC is recalling Wegmans Organic Dark Chocolate Covered Raisins because the product contains undeclared milk. The recall affects 751 cases distributed in six states.

    Product
    Organic Dark Chocolate (Covered) Raisins; Wegmans organic Dark Chocolate Covered Raisins NET WT 14 OZ (396g), UPC: 0 77890 37787 1, Product code 5546291
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0404-2018·2017-12-06

    Ruckers Makin Batch Candies Recalls Dark Chocolate Products for Undeclared Milk

    Ruckers Makin Batch Candies is recalling specific Dark Chocolate products due to undeclared milk, a potential allergen hazard.

    Product
    The Toothsome Chocolate Emporium Dark Chocolate Cranberries. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0182-2018·2017-12-06

    Arrow International Recalls Pressure Injectable PICC Kits Due to Sheath Error

    Arrow International Inc. is recalling specific lots of ADVANTAGE 5" Pressure Injectable PICC kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr sheaths.

    Product
    ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0183-2018·2017-12-06

    BD Insulin Syringes Recalled for Incorrect Needle Length Labeling

    Becton Dickinson is recalling specific lots of BD Insulin Syringes because some polybags were mislabeled with the wrong needle length and gauge.

    Product
    BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0184-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0397-2018·2017-12-06

    Pure Encapsulations AI Enzymes Recalled for Undeclared Sulfites

    Pure Encapsulations is recalling AI Enzymes dietary supplements because they contain undeclared sulfites. The products were distributed in five states.

    Product
    pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0096-2018·2017-12-06

    Teva Recalls Clozapine Tablets Due to Potential Broken Tablets

    Teva Pharmaceuticals USA is recalling 3,870 bottles of Clozapine Tablets USP, 100 mg, due to failed specifications and potential broken tablets.

    Product
    Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2018·2017-12-06

    Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs

    Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.

    Product
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0409-2018·2017-12-06

    Reese Pharmaceutical Recalls Orange Flavor Immune Support Effervescent Tablets

    Reese Pharmaceutical is recalling Orange Flavor Immune Support Effervescent Tablets because the label does not list sodium in the ingredient statement.

    Product
    Orange Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Best Choice UPC 0 70038 60863 9 & UPC 0 70038 60863 9; Discount Drug Mart UPC 0 93351 00909 9; Freds Mart UPC 0 84579 12451 0; Good Neighbor Ph
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-0180-2018·2017-12-06

    Arrow PICC Recall Due to Potential Incorrect Peel-Away Sheath Size

    Arrow International is recalling specific lots of ARROW PICC powered by ARROW VPS Stylet kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0181-2018·2017-12-06

    Arrow PICC Kits Recalled for Potential Incorrect Sheath Size

    Arrow International is recalling specific PICC kits that may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2018·2017-12-06

    Medtronic Recalls Everflex Self-Expanding Peripheral Stents Due to Labeling Error

    Medtronic is recalling 21 units of Everflex Self-Expanding Peripheral Stents because the stent length on the label may not match the actual stent length.

    Product
    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2018·2017-12-06

    Siemens N/T Protein Control SL Recalled for Inaccurate Ceruloplasmin Values

    CSL Behring GmbH is recalling Siemens N/T Protein Control SL products because they were incorrectly value-assigned, leading to biased ceruloplasmin test results.

    Product
    SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0098-2018·2017-12-06

    Mayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures

    Mayne Pharma Inc is recalling 11,364 bottles of Liothyronine Sodium Tablets 25 mcg because they failed dissolution specifications. The affected lot is distributed nationwide.

    Product
    Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0190-2018·2017-12-06

    Siemens N Protein Standard SL Recalled for Inaccurate Ceruloplasmin Calibration

    CSL Behring GmbH is recalling Siemens N Protein Standard SL and N/T Protein Controls SL due to incorrect value assignments that cause negative bias in Ceruloplasmin test results.

    Product
    SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0185-2018·2017-12-06

    Implant Direct Legacy Dental Implants Recalled for Packaging Defect

    Implant Direct Sybron Manufacturing is recalling 75 units of Legacy 3 Dental Implants because a packaging defect may compromise sterilization.

    Product
    ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0431-2018·2017-12-06

    Ian's Gluten Free Panko Breadcrumbs Recalled for Potential Beetle Exposure

    Elevation Brands is recalling Ian's Gluten Free Original Panko Breadcrumbs because raw materials may have been exposed to beetles, though no insects were found in finished products.

    Product
    Ian's Gluten Free Original Panko Breadcrumbs, UPC# 7-49512-77550-0
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0408-2018·2017-12-06

    Reese Pharmaceutical Recalls Berry Flavor Immune Support Tablets for Labeling Error

    Reese Pharmaceutical is recalling Berry Flavor Immune Support Dietary Supplement Effervescent Tablets because the label fails to list sodium in the ingredient statement.

    Product
    Berry Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Discount Drug Mart UPC 0 93351 01230 3; Good Neighbor Pharmacy UPC 0 87701 41330 8; Hyvee UPC 0 75450 09537 1; Kinray Preferred Plus UPC 0 23513
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-0095-2018·2017-12-06

    Faiza Beauty Cream Recalled for Marketing Without FDA Approval

    New Reliance Trading, Inc. is recalling No.1 Faiza Beauty Cream because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0100-2018·2017-12-06

    Vertra Sunscreen Recalled for Manufacturing Quality Deviations

    EAI-JR286 Inc. is recalling 5,355 tubes of Vertra Elemental Resistance Sunscreen due to manufacturing deviations that may impact product quality.

    Product
    Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2018·2017-12-06

    Siemens Dimension Vista Protein 1 Calibrator Recalled for Inaccurate Ceruloplasmin Results

    Siemens is recalling Dimension Vista Protein 1 Calibrators because they may produce inaccurate ceruloplasmin results below the reference range.

    Product
    Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2018·2017-12-06

    Arrow VPS Access Kit Recalled for Potential Size Mismatch

    Arrow International is recalling VPS Access Kits because they may contain 5 Fr peel-away sheaths instead of the required 4 Fr size.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0388-2018·2017-12-06

    Maple Hill Creamery Recalls Fresh Mozzarella Due to Visible Spoilage

    Maple Hill Creamery is recalling Fiore Di Latte Fresh Mozzarella because the product showed visible spoilage before the end of its shelf life.

    Product
    Maple Hill Creamery, Fiore Di Latte Fresh Mozzarella; 8-oz. (227g); UPC: 855088005474
    Category
    Food
    Distribution
    3 states
  • LowFDA (Food)·F-0432-2018·2017-12-06

    Ian's Gluten Free Italian Breadcrumbs Recalled for Potential Beetle Exposure

    Elevation Brands is recalling Ian's Gluten Free Italian Breadcrumbs because raw materials may have been exposed to beetles. No insects were found in the finished product.

    Product
    Ian's Gluten Free Italian Breadcrumbs, UPC# 7-49512-77660-6
    Category
    Food
    Distribution
    6 states
  • SevereCPSC·18047·2017-12-05

    Netgear Recalls Outdoor Camera Power Adapters Due to Fire Hazard

    Netgear is recalling VMA4700 power adapters for Arlo outdoor cameras because water leakage can cause short circuits, melting, and fire.

    Product
    Power adapters for outdoor Arlo cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18053·2017-12-05

    Metabo Recalls Rat Tail Angle Grinders Due to Laceration Hazard

    Metabo is recalling specific rat tail angle grinders because the on-off switch can lock in the on position, posing a laceration hazard.

    Product
    Rat tail angle grinders with brake
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V776000·2017-12-04

    Burch Recalls 1984 Evans Cargo Tank Trailers Due to Brake Caliper Bolts

    Burch Tank and Truck is recalling 1984 Evans Cargo Tank trailers because improperly torqued brake caliper bolts may allow the caliper to detach, increasing crash risk.

    Product
    EVANS — EVANS CARGO TANK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V778000·2017-12-04

    Triple E RV Recalls 2016-2018 Wonder Motorhomes for Seat Bolt Issue

    Triple E RV is recalling 2016-2018 Wonder motorhomes because improperly tightened passenger seat bolts may fail in a crash, increasing injury risk.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V777000·2017-12-04

    Temsa Recalls 2017-2018 Buses Due to Fire Suppression Chemical Contamination

    Temsa is recalling 2017-2018 TS30, TS35E, and TS45 buses because the fire suppression system may contain contaminated dry chemical, which could discharge improperly and increase injury risk.

    Product
    TEMSA — TEMSA TS45, TS35E, TS30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·127-2017·2017-12-01

    Rafedain Shish Kabob Recalls Chicken Patties Due to Undeclared Allergens

    Rafedain Shish Kabob Restaurant is recalling chicken patty shish kabobs because they contain undeclared milk, wheat, and soy.

    Product
    Rafedain Shish Kabob Restaurant, Inc. Recalls Chicken Patty Shish Kabob Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • CriticalUSDA FSIS·126-2017·2017-12-01

    Caesar's Pasta Recalls Beef Meatballs for Undeclared Egg Allergen

    Caesar's Pasta is recalling approximately 46,810 pounds of frozen beef meatballs because they contain egg, a known allergen, that is not declared on the label.

    Product
    Caesar's Pasta, LLC — Caesar's Pasta, LLC Recalls Beef Meatball Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V772000·2017-12-01

    MV Agusta Recalls 2017 Brutale 800 Dragster RR for Rear Wheel Spokes

    MV Agusta is recalling 45 2017 Brutale 800 Dragster RR motorcycles because rear wheel spokes may loosen, potentially affecting handling and increasing crash risk.

    Product
    MV AGUSTA — MV AGUSTA BRUTALE 800 DRAGSTER RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V775000·2017-12-01

    Ford Recalls 2018 Expedition Vehicles for Seat Back Bolt Defect

    Ford is recalling 2018 Expedition vehicles because second-row outboard seats may have improperly installed bolts or excessive forward adjustment, increasing injury risk in a crash.

    Product
    FORD — FORD EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V773000·2017-12-01

    Kia Recalls 2012-2014 Forte Models Due to Brake Pedal Stopper Pad Defect

    Kia is recalling 2012-2014 Forte and Forte Koup vehicles because a deteriorating brake pedal stopper pad may keep brake lights on or allow shifting without pressing the brake pedal.

    Product
    KIA — KIA FORTE KOUP, FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18051·2017-12-01

    Camso Recalls Dirt to Snow Bike Conversion Kits Due to Crash Hazards

    Camso is recalling DTS 129 conversion kits because a brake pin can loosen, posing a crash or impact hazard. No injuries have been reported.

    Product
    Camso dirt to snow bike conversion kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2017.