The Recall Desk

Archive

November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical
142
Severe
250
High
301
Moderate
124
Low
29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.

1–100 of 846

  • SevereNHTSA·18V853000·2018-11-30

    Keystone Recalls 2019 Montana Trailers Due to Axle Weld Defects

    Keystone RV Company is recalling 2019 Montana recreational trailers because defective axle welds could cause the wheel assembly to detach, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE MONTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V851000·2018-11-30

    Jayco Recalls 2019 Travel Trailers Due to Insufficient Wheel Bearing Grease

    Jayco is recalling 2019 Jay Flight SLX, Jay Feather, and White Hawk travel trailers because inner wheel hub bearings may lack sufficient grease, risking overheating and hub failure.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX, JAY FEATHER, WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V852000·2018-11-30

    Heartland Recalls 2019 Fifth-Wheel Trailers for Missing Reflectors

    Heartland is recalling 2019 fifth-wheel trailers because forward reflectors may be missing, reducing visibility and increasing crash risk.

    Product
    HEARTLAND — HEARTLAND MILESTONE, ELK RIDGE, SUNDANCE, PIONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V850000·2018-11-29

    Mercedes-Benz Recalls Vehicles Due to Steering Rack Locknut Failure Risk

    Mercedes-Benz is recalling specific 2015-2019 models because a steering rack locknut may break, causing the steering to stick and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 350 E, E 300, C 300, CLS 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V849000·2018-11-29

    Mercedes-Benz Recalls 2019 Wagons Due to Spoiler Detachment Risk

    Mercedes-Benz is recalling 2019 E450 and E63S Wagons because the tailgate spoiler may detach while driving, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E 450, AMG E63S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V837000·2018-11-29

    Mercedes-Benz Metris Fuel Hose Leak Recall

    Daimler Vans USA is recalling 2016-2017 Mercedes-Benz Metris vehicles because a fuel hose may leak, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0652-2019·2018-11-28

    Bazzini Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling specific lots of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINIS ROASTED & SALTED IN-SHELL PISTACHIOS RAMS HEAD NATURAL 16 OZ BAG UPC #0 75062 00536 2 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • CriticalFDA (Food)·F-0657-2019·2018-11-28

    Sprout Creek Farm Recalls Margie Cheese Contaminated with Listeria monocytogenes

    Sprout Creek Farm, Inc. is recalling Margie Cheese wheels contaminated with Listeria monocytogenes. The recall affects one-pound wheels sold in New York.

    Product
    Margie Cheese. It is packaged with a green round label, wrapped in white milk paper in one-pound wheels.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0651-2019·2018-11-28

    Bazzini Roasted Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling 25 lb boxes of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL SUPER COLOSSAL PISTACHIOS 25 LB BULK BOX UPC #0 75062 30700 8
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0270-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 75 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0267-2019·2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V847000·2018-11-28

    Altec Recalls 2017 Aerial Devices Due to Pedestal Fastener Defect

    Altec is recalling 2017 AT37, AT41, and AT48 aerial devices because loose or missing fasteners may cause the pedestal to separate, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0478-2019·2018-11-28

    Voluntis Recalls Insulia Diabetes Management Companion Due to Calculator Bug

    Voluntis is recalling the Insulia Diabetes Management Companion because a bug in the Android basal calculator could cause hypoglycemia. An update is available to resolve the issue.

    Product
    Insulia Diabetes Management Companion
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0488-2019·2018-11-28

    Sedecal NOVA FA DR System Recalled for Potential Cable Failure

    Sedecal S.A. is recalling 145 NOVA FA DR diagnostic radiography systems because installation or maintenance issues could cause support cables to break, leading to equipment falling.

    Product
    Sedecal NOVA FA DR System. for diagnostic radiography.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0268-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made i
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling 12,502 bottles of Irbesartan 300 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18E109000·2018-11-28

    TSE Brakes Recalls Air Brake Actuators Due to Washer Fracture Risk

    TSE Brakes is recalling specific Air Brake Actuators because mounting washers may fracture, potentially reducing braking ability and increasing crash risk.

    Product
    SERVICE BRAKES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0272-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, USP, 300 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0698-2019·2018-11-28

    Recchiuti Bittersweet Dark Chocolate Recalled for Undeclared Milk Protein

    Confections by Michael Recchiuti is recalling specific lots of Bittersweet Dark Chocolate because FDA analysis found high levels of milk protein.

    Product
    Recchiuti Bittersweet, Smooth, rich and complex. Net Wt. 3 oz. (85 G) Also sold in case of 12 UPC 8019895 00017 6 Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Natural vanilla extract, cacao paste. Contains: soy Made on equip
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V841000·2018-11-28

    Porsche Recalls 2018 Panamera Hybrid Models for Brake Line Corrosion

    Porsche is recalling 2018 Panamera Hybrid models because front brake lines may corrode, potentially reducing braking performance and increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0658-2019·2018-11-28

    Elaboraciones Felo Pizza Turnovers Recalled for Undeclared Wheat and Soy Allergens

    Elaboraciones Felo, Inc. is recalling Pizza Turnovers because the products failed to declare wheat and soy allergens. The recall covers 7,011 cases distributed in Puerto Rico.

    Product
    Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0264-2019·2018-11-28

    Golden State Medical Supply Recalls Irbesartan Tablets Due to Impurity

    Golden State Medical Supply is recalling Irbesartan 150 mg tablets because FDA testing found the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0263-2019·2018-11-28

    FDA Recalls Irbesartan Tablets Due to NDEA Impurity

    Golden State Medical Supply Inc. is recalling 2,439 bottles of Irbesartan 75 mg tablets because FDA testing confirmed the presence of the impurity N-nitrosodiethylamine (NDEA).

    Product
    IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0474-2019·2018-11-28

    Boston Scientific Recalls SQ-RX Pulse Generators for Battery Malfunctions

    Boston Scientific is recalling 12,900 SQ-RX Pulse Generators used in S-ICD systems due to latent internal battery malfunctions that cause accelerated depletion.

    Product
    The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have sympto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0271-2019·2018-11-28

    Sciegen Pharmaceuticals Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling GSMS Irbesartan Tablets, 150 mg, because FDA testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA).

    Product
    GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0269-2019·2018-11-28

    Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

    Sciegen Pharmaceuticals is recalling Irbesartan 300mg tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

    Product
    Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in t
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0649-2019·2018-11-28

    Bazzini Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling 4,000 lbs of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS SUPER COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30701 5 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·18V846000·2018-11-28

    Blue Bird Recalls School Buses Due to Seat Detachment Risk

    Blue Bird is recalling certain 2019-2020 school buses because seats may detach from the floor in a crash, increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V848000·2018-11-28

    Honda Recalls 2019 Ridgeline and Pilot for Air Bag Deployment Risk

    Honda is recalling 2019 Ridgeline and Pilot vehicles because a trim panel clip may interfere with right-side curtain air bag deployment in a crash.

    Product
    HONDA — HONDA RIDGELINE, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V845000·2018-11-28

    Ford Recalls 2016-2018 Focus Models Due to Clutch Fracture Risk

    Ford is recalling 2016-2018 Focus vehicles with 1.0L engines and manual transmissions because a clutch fracture could cause a fluid leak and fire risk.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0699-2019·2018-11-28

    Recchiuti Dairy-Free Dark Chocolate Recalled for Undeclared Milk Protein

    Confections by Michael Recchiuti is recalling specific lots of Recchiuti Feve Dark Chocolate because FDA analysis found high levels of milk protein in the dairy-free product.

    Product
    Recchiuti Feve. Net Wt. 3 oz. (85 G) Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Natural vanilla extract, cacao paste, cacao nibs.. Contains: soy Made on equipment also shared with soy, milk, wheat, eggs, peanuts and tree n
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V843000·2018-11-28

    Keystone RV Recalls 2019 Travel Trailers Due to Axle Hub Bearing Defect

    Keystone RV Company is recalling certain 2019 recreational trailers because the inner axle hub bearings may not have been sufficiently greased, which could cause overheating, hub failure, and increased crash risk.

    Product
    KEYSTONE — KEYSTONE, DUTCHMEN OUTBACK, BULLET, AEROLITE, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0653-2019·2018-11-28

    Bazzini Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling specific lots of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS COLOSSAL NATURAL 16 OZ BAG UPC #0 75062 00535 5 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-0473-2019·2018-11-28

    LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts

    LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.

    Product
    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0471-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Amplifier Board Defect

    Beckman Coulter is recalling Cytomics FC 500 and EPICS XL flow cytometers due to a manufacturing defect on the amplifier board that may cause signal loss or drifting.

    Product
    1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0629-2019·2018-11-28

    Perfect Bite Co. Recalls Southwest Style Vegetable and Quinoa Protein Blend

    The Perfect Bite Co. is recalling a frozen vegetable and grain blend because the label lists quinoa but the product contains undeclared wheat.

    Product
    Southwest Style Vegetable & Quinoa Protein Blend; Corn, Farro, Brown Rice, Red Bell Peppers, Black Beans, Poblano peppers, Scallions in a spicy citrus chili sauce. NET WT. 10 oz. (283G) Steam Ready, cooks perfectly in the bag! Keep Frozen Ingredients: Yellow Corn, Cooked
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0628-2019·2018-11-28

    Gatorade Vanilla Protein Shake Recalled for Bacillus Cereus Bacteria

    PepsiCo is voluntarily recalling specific 12-pack cases of Gatorade Vanilla Protein Shake because they may contain Bacillus cereus bacteria.

    Product
    Gatorade Vanilla Protein Shake, 330-mL, Primary Package HDPE in a 12pk case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0640-2019·2018-11-28

    Mast Store Provisioners Golden Caramel Corn Nuggets Recalled for Incorrect Labeling

    Lehi Valley Trading Co. is recalling 126 bags of Mast Store Provisioners Golden Caramel Corn Nuggets because the ingredient and allergen information on the label is incorrect.

    Product
    Mast Store Provisioners, Golden Caramel Corn Nuggets, Net Wt. 6 OZ. clear plastic bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0627-2019·2018-11-28

    Sunnyside Orchards Apple Cider Recalled for Potential Under-Processing

    Sunnyside Orchards is recalling 737 gallons of apple cider in Minnesota due to potential under-processing.

    Product
    Sunnyside Orchards Apple Cider in Half-Gallon and Gallon plastic containers. Keep Refrigerated. Processed by: Sunnyside Orchards, 6051 NW 75th St, Pennock MN 56279
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0655-2019·2018-11-28

    Zinetti Roasted Vegetable Blend Recalled for Listeria and Salmonella Risk

    Harvest Food Group is recalling Zinetti Roasted Vegetable Blend due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Zinetti Roasted Vegetable Blend; 40lb. bulk case; Keep Frozen; Item# ZIN-RSVB-0040
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-0624-2019·2018-11-28

    Cadence Gourmet Roasted Vegetables Recalled for Potential Pathogen Contamination

    Cadence Gourmet LLC is recalling Balsamic Roasted Vegetables due to potential Salmonella and Listeria contamination from McCain Foods USA ingredients.

    Product
    Cadence Gourmet Balsamic Roasted Vegetables; Net Weight: 10 lbs. (4.5 kg)/ cs UPC: 00851124006382 Ingredients: Zucchini, Artichoke, White Balsamic Sauce (Balsamic vinegar {wine vinegar, grape concentrate, Natural Flavor, Contains Sulfites] Olive Oil, Walnut Oil, Honey, Garli
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0630-2019·2018-11-28

    Gilster-Mary Lee Recalls Microwave Popcorn for Undeclared Milk Allergen

    Gilster-Mary Lee is recalling microwave popcorn distributed by Schnuck Markets in Missouri because the product contains butter but fails to declare milk on the label.

    Product
    Microwave Movie Theater Butter Popcorn, Naturally Flavored, Net Wt. 19.8 OZ (1 lb 3.8 OZ), Distributed by Schnuck Markets, Inc. St. Louis, MO 63146
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0626-2019·2018-11-28

    Cadence Gourmet Cauliflower & Cheese recall due to potential Salmonella and Listeria contamination

    The FDA is recalling Cadence Gourmet Cauliflower & Cheese because of potential Salmonella and/or Listeria Monocytogenes contamination.

    Product
    Cadence Gourmet Cauliflower & Cheese Net Weight: 10 lbs. (4.4 kg) / cs UPC: 00851124006375 Ingredients: Cauliflower, B¿chamel Sauce (Milk, Cultured Cream, Vegetable Broth [Water, sauteed Vegetables {carrots, celery, onions, tomatoes}, Salt, Yeast Extract, Dried Onion and Gar
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0482-2019·2018-11-28

    GE Healthcare Recalls Panda iRes Infant Radiant Warmers Due to Electric Leakage

    GE Healthcare is recalling 1,724 Panda iRes Infant Radiant Warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0623-2019·2018-11-28

    Cadence Gourmet Recalls Roasted Corn Salsa for Potential Contamination

    Cadence Gourmet LLC is recalling Roasted Corn Salsa manufactured for Corner Bakery Café due to potential Salmonella and/or Listeria monocytogenes contamination.

    Product
    Roasted Corn Salsa; Net Weight: 10 lbs. (10 x 1 lb. bags) Corner Bakery Caf¿ Brand Ingredients: Corn, Red Onion, Jalapeno, Lime Juice, Canola Oil, Cilantro, Salt. Keep Frozen. Manufactured for Corner Bakery Caf¿, Cornet Bakery Caf¿, Callas, TZ 75251
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0486-2019·2018-11-28

    Ascom Telligence Nurse Call System Recalled for Communication Failure

    Ascom (US) Inc. is recalling 57 units of the Telligence Nurse Call System because a gateway defect may prevent device failures from being displayed at staff consoles.

    Product
    Ascom Telligence Nurse Call System
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0475-2019·2018-11-28

    Tosoh AIA-2000 Analyzer Recall Due to Potential Wash Solution Defect

    Tosoh Bioscience is recalling seven AIA-2000 analyzers because a liquid suction pump defect may cause incomplete washing, leading to inaccurate test results.

    Product
    AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2019·2018-11-28

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage

    GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect

    Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.

    Product
    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0656-2019·2018-11-28

    Path of Life Southwest Quinoa Recalled for Listeria and Salmonella Risk

    Harvest Food Group is recalling Path of Life All Natural Southwest Quinoa due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Path of Life All Natural Southwest Quinoa; 10oz., 6 and 12 units per case; Keep Frozen; UPC 855229005035; Item# POL-RSWN-1210 and POL-RSWQ-0610
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0480-2019·2018-11-28

    GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0266-2019·2018-11-28

    L. Perrigo Recalls Calcium Carbonate Antacid Tablets Due to Metal Particles

    L. Perrigo is recalling specific lots of calcium carbonate antacid tablets because they were found to contain metal particles.

    Product
    Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0654-2019·2018-11-28

    Harvest Food Group Recalls Mexican Style Roasted Corn for Listeria and Salmonella

    Harvest Food Group is recalling Signature Select Mexican Style Roasted Corn due to potential contamination with Listeria monocytogenes or Salmonella.

    Product
    Signature Select Mexican Style Roasted Corn; 12 oz.; 12/12oz. units per case; Keep Frozen Until Ready To Use; UPC 02113094060; Item# 21130-09406
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0479-2019·2018-11-28

    GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2019·2018-11-28

    GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk

    GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0625-2019·2018-11-28

    Cadence Gourmet Recalls Roasted Vegetable Blend for Potential Pathogen Contamination

    Cadence Gourmet LLC is recalling Roasted Vegetable Blend due to potential Salmonella and Listeria contamination from McCain Foods USA ingredients.

    Product
    Roasted Vegetable Blend; Net Weight: 30 lbs. (12 x 2.5 lb. bags) Corner Bakery Caf¿ Brand Ingredients: Zucchini, artichoke (water, citric acid and calcium chloride). Tomatoes, olive oil, canola oil, garlic, vinegar (potassium metabisulfite), salt, black pepper, spices. Ke
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0661-2019·2018-11-28

    Elaboraciones Felo Square Turnover Shells Recalled for Undeclared Allergens

    Elaboraciones Felo, Inc. is recalling Square Shell for Turnovers because the product failed to declare wheat, soy, and Red No. 40.

    Product
    Square Shell for Turnovers, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0650-2019·2018-11-28

    Bazzini Roasted Pistachios Recalled Due to Salmonella Contamination

    Bazzini LLC is recalling 5 lb bags of roasted and salted in-shell pistachios because the product tested positive for Salmonella.

    Product
    BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30711 4 THE BAGS ARE RED, WHITE AND BLUE.
    Category
    Food
    Distribution
    12 states
  • HighNHTSA·18V844000·2018-11-28

    Porsche Recalls 2017-2018 Models Due to Ski Bag Strap Defect

    Porsche is recalling certain 2017-2018 Cayenne and Macan vehicles because the optional ski bag strap may tear, increasing injury risk in a crash.

    Product
    PORSCHE — PORSCHE CAYENNE, MACAN, MACAN GTS, MACAN S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0631-2019·2018-11-28

    Fairview Mills Recalls Corn Flour Due to Undeclared Gluten

    Fairview Mills Inc is recalling bulk corn flour because testing found gluten, which is not declared on the label.

    Product
    DIDGFPGB, Food Grade Pre-Gel Corn Flour. Bulk
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0634-2019·2018-11-28

    Mast Store Provisioners Trail Mix Recalled for Incorrect Allergen Labeling

    Lehi Valley Trading Co. is recalling 96 bags of Mast Store Provisioners Sweet 'N Spicy Trail mix because the ingredient and allergen information is incorrect.

    Product
    Mast Store Provisioners, Simply Kettle Sweet 'N Spicy Trail, Net Wt. 8 OZ. clear plastic bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0494-2019·2018-11-28

    BD Vacutainer Urine Cup Kit Recall for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0487-2019·2018-11-28

    FDA Mandates Recall of PremierPro Aluminum Adjustable Walkers

    SVS LLC is recalling 256 PremierPro Aluminum Adjustable Walkers due to an FDA order for stock recovery and return of imported items.

    Product
    PremierPro Aluminum Adjustable Walker
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0489-2019·2018-11-28

    Merck Minicon Clinical Sample Concentrators Recalled for Performance Issues

    Merck Millipore is recalling Minicon Clinical Sample Concentrators because they may take up to 24 hours to concentrate samples, delaying diagnostic tests.

    Product
    Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2019·2018-11-28

    Binding Site Human IgM Kit Recalled for Reduced Accuracy

    The Binding Site Group is recalling 108 units of Human IgM Kits due to reduced accuracy in control results and potential out-of-range readings.

    Product
    Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative an
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0476-2019·2018-11-28

    Ortho-Clinical VITROS dLDL Reagent Recalled for Negatively Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products dLDL Reagent GENs 26 and 27 because the in vitro diagnostic may produce negatively biased results.

    Product
    VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0495-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0388-2019·2018-11-28

    GE Healthcare Recalls DeltaVision OMX SR Imaging Systems Due to Interlock Defect

    GE Healthcare Biosciences is recalling 39 DeltaVision OMX SR Imaging Systems because the safety interlocks are not wired to be single-fault tolerant.

    Product
    DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflectio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0273-2019·2018-11-28

    Nitrofurantoin Capsules Recalled for Potential Cross-Contamination with Unrelated Ingredients

    American Health Packaging is recalling specific lots of Nitrofurantoin Capsules due to potential cross-contamination with unrelated active ingredients.

    Product
    Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0492-2019·2018-11-28

    BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation

    Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts when used with specific analyzers.

    Product
    BD Vacutainer Specimen Collection Cups, Cat. No. 364975
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0493-2019·2018-11-28

    BD Urine Collection Cups May Elevate Red Blood Cell Counts

    Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.

    Product
    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0633-2019·2018-11-28

    Mast Store Provisioners Fried Peanuts Recalled for Incorrect Allergen Labeling

    Lehi Valley Trading Co. is recalling 96 bags of Mast Store Provisioners Shell 'N All Fried Peanuts because the ingredient list and allergen information are incorrect.

    Product
    Mast Store Provisioners, Shell 'N All Fried Peanuts, Net Wt. 8 OZ. clear plastic bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0283-2019·2018-11-28

    Dr. Reddy's Recalls Clopidogrel Tablets Due to Dissolution Failure

    Dr. Reddy's Laboratories is recalling specific lots of Clopidogrel Bisulfate tablets because they failed dissolution testing during stability checks.

    Product
    CLOPIDOGREL BISULFATE — CLOPIDOGREL BISULFATE (CLOPIDOGREL BISULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0663-2019·2018-11-28

    Little Salad Bar Cranberry Walnut Salad Recalled for Incorrect Ingredient Labeling

    Ready Pac Foods is recalling Little Salad Bar Cranberry Walnut Salad because the ingredient label on the container is incorrect and fails to declare wheat and walnuts.

    Product
    Little Salad Bar Cranberry Walnut Salad: Spring Mix, Dried Cranberries, Candied Walnuts, Feta Cheese, Flat Bread Chips, Raspberry Vinaigrette: Net Wt. 4.5 oz. Ingredient label on the bottom of the clear plastic container is for Chicken Caesar Salad. Distributed by Aldi
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0667-2019·2018-11-28

    Diamond Crystal Barbecue Sauce Recalled for Missing Ingredient Labels

    Diamond Crystal Brands is recalling House Blend Barbecue Sauce because the labels are missing required ingredient information, including soybean oil.

    Product
    HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BRANDS, INC. SAVANNAH, GA 31405
    Category
    Food
    Distribution
    11 states

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