The Recall Desk

Archive

May 2015 recalls

653 recalls were announced in May 2015.

What the numbers show

Critical
52
Severe
145
High
352
Moderate
90
Low
14

Of the 653 recalls this month scored against our rubric, 8% are Critical, 22% are Severe.

1–100 of 653

  • SevereUSDA FSIS·084-2015·2015-05-29

    Total Packaging Recalls Turkey and Cheese Lunch Kits for Undeclared Egg

    Total Packaging of KY, Inc. is recalling approximately 18,000 pounds of Anytime Foods Turkey and Cheese Lunch Kits because they contain egg, an allergen not listed on the label.

    Product
    Total Packaging of KY, Inc. Recalls Turkey and Cheese Lunch Kits Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·15V326000·2015-05-29

    Genie TZ-34/20 Trailers Recalled for Outrigger Drift Risk

    Genie is recalling 2015 TZ-34/20 trailers because out-of-specification cylinders may cause outriggers to drift, increasing the risk of tip-over and injury.

    Product
    GENIE — GENIE TZ-34/20
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·15V320000·2015-05-28

    Honda and Acura Recall Vehicles for Air Bag Inflator Rupture Risk

    Honda is recalling specific 2001-2011 Honda and Acura vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    ACURA — ACURA, HONDA MDX, CR-V, PILOT, ELEMENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·15V318000·2015-05-28

    BMW Recalls 2002-2006 Models for Driver Air Bag Inflator Rupture Risk

    BMW is recalling specific 2002-2006 models because moisture can cause the driver's air bag inflator to rupture, potentially sending metal fragments into the cabin during a crash.

    Product
    BMW — BMW 325XI, 325I, 325CI, 330CI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V323000·2015-05-28

    Subaru and Saab Recall Vehicles for Airbag Inflator Rupture Risk

    Subaru and Saab are recalling specific 2003-2008 models because moisture can cause the passenger airbag inflator to rupture, potentially sending metal fragments into the cabin.

    Product
    SUBARU — SUBARU, SAAB LEGACY, OUTBACK, 9-2X, IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V324000·2015-05-28

    GM Recalls 2007-2008 Trucks for Passenger Air Bag Inflator Defect

    General Motors is recalling 2007-2008 Chevrolet and GMC trucks because the passenger air bag inflator may rupture during deployment, potentially causing serious injury.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SIERRA 2500, SILVERADO 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V319000·2015-05-28

    Ford Recalls Mustang and GT Vehicles for Air Bag Defect

    Ford is recalling 2005-2014 Mustangs and 2005-2006 GTs because the driver's air bag inflator may rupture in a crash, posing a risk of serious injury or death.

    Product
    FORD — FORD GT, MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15152·2015-05-28

    GT Fury Mountain Bicycles Recalled Due to Front Wheel Hub Failure Risk

    Cycling Sports Group is recalling 2015 GT Fury Elite and Expert downhill mountain bicycles because the front wheel hub can break, causing disc brake failure and crash hazards.

    Product
    GT downhill mountain bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15151·2015-05-28

    Mason Jar Night Light Recalled Due to Burn Hazard

    Nantucket Distributing is recalling Mason Jar Night Lights because the plastic base can melt, posing a burn hazard. No injuries have been reported.

    Product
    Mason Jar Night Light
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2313-2015·2015-05-27

    Taylor Farms Recalls Spinach Bags Due to Salmonella Test Result

    Taylor Farms California, Inc. is voluntarily recalling select bags of spinach after a random sample tested positive for Salmonella.

    Product
    Spinach; Packaging configurations per case: One 4 pound bag; Four 2.5 bags; Four 1 pound bags;
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2319-2015·2015-05-27

    Starbucks Black & White Mini Cookies Recalled for Undeclared Milk

    Sweet Sam's Baking Company is recalling Starbucks Black & White Mini Cookies because they contain undeclared milk and soy lecithin.

    Product
    Black & White Mini Cookies, Net Wt. 2 oz. (56 g), SKU 408785, UPC code 833282000495, Manufactured for: Starbucks Coffee Company, Seattle, WA --- The product comes in a clear film package, each containing two cookies. Each case contains 12 - 2 oz. packages (units).
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2309-2015·2015-05-27

    Hines Nut Company Recalls Walnuts Halves and Pieces for Salmonella

    Hines Nut Company is recalling 16-ounce trays of walnuts halves and pieces because the product tested positive for Salmonella. The recall affects 128 cases distributed in Texas.

    Product
    Walnuts Halves & Pieces in black foam trays with a green and gold label. Net Weight 16-oz 454.0 grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2304-2015·2015-05-27

    Texas Pecan Co Recalls Macadamia Nuts for Salmonella Contamination

    Texas Pecan Co is recalling macadamia nuts in 8 oz and 16 oz bags due to potential Salmonella contamination. The product was distributed in 15 states.

    Product
    Macadamia Nuts in 8 oz and 16 oz clear plastic bags.
    Category
    Food
    Distribution
    15 states
  • CriticalFDA (Food)·F-2318-2015·2015-05-27

    Whole Foods Market Recalls Raw Macadamia Nuts for Salmonella Risk

    Whole Foods Market is recalling raw macadamia nuts due to potential Salmonella contamination. The product was distributed in Texas, Oklahoma, and Louisiana.

    Product
    WHOLE FOODS MARKET Raw MACADAMIA NUTS NET WT 11OZ (312g) Distributed by Whole Foods Market Austin, TX 78703
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2308-2015·2015-05-27

    Patel Grocery Cumin Powder Recalled for Undeclared Peanut Protein

    Patel Grocery Corp is recalling America's Best Cumin Powder because it contains undeclared peanut protein, posing a risk to individuals with peanut allergies.

    Product
    AMERICA'S BEST (JEERA) CUMIN POWDER, 1) NET WT. 7 OZ. (200 GMS), 2) 14 OZ. (400 GMS), and 3) 28 OZ. Packed by: Patel Grocery 5303 4th Avenue Brooklyn, NY 11220 Tel: 718-748-6369
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V314000·2015-05-27

    Crane Carrier Recalls 2008-2015 Trucks Due to Engine Fire Risk

    Crane Carrier is recalling 630 model year 2008-2015 COE, LDT2, and LET2 trucks because a vent tube defect may allow engine oil to contact hot surfaces, increasing fire risk.

    Product
    CRANE — CRANE COE, LET2, LDT2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2305-2015·2015-05-27

    Texas Pecan Company Recalls Macadamias Due to Salmonella Contamination Risk

    Texas Pecan Company is recalling roasted and salted macadamias due to a potential Salmonella contamination risk. Consumers should check their pantries for the affected products.

    Product
    Texas Pecan Company Macadamias Roasted/Salted Net Wt. 16 oz. (454g) UPC: 033; Manufactured By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878; Texas Pecan Company Macadamias Roasted/Salted Net Wt. 8 oz. (227g) UPC: 034; Manufactured By: Texas Pecan Co., 2850 S
    Category
    Food
    Distribution
    15 states
  • SevereNHTSA·15V317000·2015-05-27

    Keystone and Dutchmen Recalling 2015 Fifth Wheels for Expanding Room Defect

    Keystone RV Company is recalling 2015 Keystone and Dutchmen fifth wheels because screws securing the expanding room may fail, increasing crash risk.

    Product
    DUTCHMEN — DUTCHMEN, KEYSTONE KODIAK, AEROLITE, CARBON, ALPINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1623-2015·2015-05-27

    GE Healthcare Recalls CT Scanners Due to Over-Torqued Bolts

    GE Healthcare is recalling four CT scanners because over-torqued bolts could cause a component to detach, posing a risk of serious bodily injury.

    Product
    CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-2316-2015·2015-05-27

    Gouveia Crushed Red Pepper Recalled for Undeclared Allergens

    Gouveia & Sons Imports is recalling Gouveia Crushed Red Pepper because it fails to declare FD&C Yellow #5 and sulfites.

    Product
    Gouveia Crushed Red Pepper Imported from the Azores Pimenta Moida, Packed in glass jar, Net Wt 16 oz
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V316000·2015-05-27

    Eldorado Axess, XHF, and E-Z Rider II Recalled for Engine Fire Risk

    Eldorado is recalling 2007-2015 Axess, XHF, and E-Z Rider II vehicles because a vent tube defect may allow engine oil to contact hot surfaces, increasing fire risk.

    Product
    ELDORADO — ELDORADO AXESS, XHF, E-Z RIDER II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2015·2015-05-27

    Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect

    Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.

    Product
    ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1643-2015·2015-05-27

    Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation

    Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.

    Product
    Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2185-2015·2015-05-27

    Superior Foods Recalls Organic Chopped Spinach Due to Possible Listeria Contamination

    Superior Foods is recalling Simply Balanced Organic Chopped Spinach due to possible Listeria contamination. Consumers should not eat the product and should return it to the store.

    Product
    Simply Balanced Organic Chopped Spinach NET WT 10 OZ (283g) steam-in-bag Needs to be fully cooked Keep frozen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2297-2015·2015-05-27

    Greystone Foods Recalls Frozen Field Peas Due to Listeria Risk

    Greystone Foods is recalling 11,004 bags of Today's Harvest Field Peas w/Snaps due to possible Listeria monocytogenes contamination. The product was distributed in Florida and Georgia.

    Product
    Today's Harvest(TM) Field Peas w/Snaps, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2307-2015·2015-05-27

    Texas Pecan Co. Recalls Sweet-N-Salty Nuts Due to Salmonella Risk

    Texas Pecan Co. is recalling specific lots of Sweet-N-Salty Nuts because they may be contaminated with Salmonella.

    Product
    Mini Sweet-N-Salty Nuts UPC 335-26 Net Wt. 27 ozs. (766g) Manufactured By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878. The macadamia nuts are in one section of the 2 pound tin container; Sweet-N-Salty Nuts 337-56 Net Wt. 63 ozs. (1788g) Manufactured By: Tex
    Category
    Food
    Distribution
    15 states
  • HighNHTSA·15V315000·2015-05-27

    Toyota Recalls 2015 Tundra for Incorrect Tire Pressure Placard

    Southeast Toyota Distributors is recalling 144 model year 2015 Toyota Tundra vehicles because the tire placard lists incorrect inflation pressure, which could lead to underinflation and tire failure.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2306-2015·2015-05-27

    Texas Pecan Co. Recalls Nut Assortments Due to Salmonella Contamination

    Texas Pecan Co. is recalling specific nut assortments because they may be contaminated with Salmonella. Consumers should check their products and stop eating them.

    Product
    The Junior Executive (Nut Assortment) UPC: 320-34 Net Wt. 27 ozs. (766g) Manufactured By: Texas Pecan Co., Inc. 2850 Satsuma Dr. Dallas TX 75229 972-241-7878. The macadamia nuts are in one section of the 3 pound tin container; The Executive (Nut Assortment) UPC: 321-54 Net Wt.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-2300-2015·2015-05-27

    Alpine Bistro 7-Layer Bar Recalled for Undeclared Wheat Allergen

    Alpine Bistro & Bakery Company is recalling 7-Layer Bars because they contain wheat but are labeled as Graham crackers without declaring the wheat allergen.

    Product
    7 -Layer Bar, 7-ounce(200 gram) flexible plastic wrap with adhesive-backed label.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2310-2015·2015-05-27

    Bridge City Baking Recalls Gluten-Free Pies Due to Undeclared Milk

    Bridge City Baking LLC is recalling frozen gluten-free Marionberry Crumble Pies because butter is listed without its sub-ingredient, milk.

    Product
    BRIDGE CITY Baking gluten free Marionberry Crumble Pie. This product is frozen ready to bake. Net Wt 24oz UPC 0 91037 54454 4
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2298-2015·2015-05-27

    Greystone Foods Recalls Frozen Corn for Possible Listeria Contamination

    Greystone Foods is recalling 2,370 bags of Today's Harvest Silver Queen style Corn due to possible Listeria monocytogenes contamination. The product was distributed in Florida and Georgia.

    Product
    Today's Harvest(TM) Silver Queen style Corn, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1631-2015·2015-05-27

    Philips EPIQ 5 Ultrasound System Recalled for Body Surface Area Calculation Error

    Philips is recalling EPIQ 5 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations when using Metric settings.

    Product
    EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number: 795204 / 795205. Part Number: 989605408541 With 453561736761 (1.1) 453561750041 (1.1.1) 453561753651 (1.1.2) 453561772231 (1.2) 453
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2317-2015·2015-05-27

    Smith's Bakery Fresh Carrot Cake Recalled for Missing Allergen Labeling

    Smith's Food and Drug is recalling fresh carrot cake because the scale label failed to print the full ingredient statement and required allergen information.

    Product
    Smith's Bakery brand fresh carrot cake, net weight 5 ounces 7 50903 91714 0, 22 ounce 1.38 pound 1/8 Sheet) 7 70118 22460 4, 82 ounce (5.13 pound 1/4 sheet) 0 41573 07058 8 Smith's Food & Drug Stores
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1639-2015·2015-05-27

    Richard Allan Scientific Recalls Mucolytic Agent Due to Fungal Contamination

    Richard Allan Scientific is recalling Mucolytic Agent and Mucolexx after a customer complaint reported fungal contamination in two lots of Mucolexx.

    Product
    Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2299-2015·2015-05-27

    Greystone Foods Recalls Broccoli Florets Due to Possible Listeria Contamination

    Greystone Foods is recalling 1,692 bags of Today's Harvest Broccoli Florets due to possible Listeria monocytogenes contamination. The product was distributed in Florida and Georgia.

    Product
    Today's Harvest(TM) Broccoli Florets, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2302-2015·2015-05-27

    Superior Nut & Candy Pine Nuts Recalled for Salmonella Risk

    Superior Nut & Candy Dist. Co. is voluntarily recalling 4-ounce containers of pine nuts in North Carolina due to potential Salmonella contamination.

    Product
    The product comes in a 4-ounce clear plastic tear-strip enclosed container. The pine nuts are sold in store Produce Departments with a clear package front and tan-colored label on the back. The back label list Pine Nuts as the only ingredient.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2314-2015·2015-05-27

    Waymouth Farms Recalls Raw Pine Nuts Due to Salmonella Risk

    Waymouth Farms is recalling specific brands and sizes of raw pine nuts because they may be contaminated with Salmonella.

    Product
    Raw Pine Nuts sold in the following brands and package sizes: -Good Sense 3 oz. (85g) bag UPC 30243-86681, -Good Sense 4 oz. (113g) bag, UPC 30243-86680, -Good Sense 4 oz. (113g) tub UPC 30243-50799, -Good Sense 15 oz. (425g) bag UPC 30243-86687, -Good Sense 5 lb
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2015·2015-05-27

    Roche Homocysteine Test System Recalled for Inaccurate Low Results

    Roche Diagnostics is recalling Homocysteine Reagent lots due to complaints of under-recovery and falsely low patient results, which could delay diagnosis of peripheral vascular disease.

    Product
    Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2315-2015·2015-05-27

    Jose' Madrid Black Bean Corn Poblano Salsa Recalled for Underprocessing

    Michael Zakany LLC is recalling 123 jars of Jose' Madrid Black Bean Corn Poblano Salsa because the product appears to be under-processed.

    Product
    Jose' Madrid SALSA BLACK BEAN CORN POBLANO SALSA NET WT 13 OZ (369 G) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934***0 93662 45287 4
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-2303-2015·2015-05-27

    Deer Cumin Powder Recalled for Undeclared Peanuts

    Best Foods NJ, Inc. is recalling Deer Cumin Powder in 7 oz and 14 oz packages due to undeclared peanuts.

    Product
    Deer Cumin Powder Packed for Best Foods Inc., Edison, NJ 08817 a) 7 oz. UPC 71476027497 b) 14 oz..UPC 714760027503 Not all packages are marked with a UPC barcode 12 packages to a case
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2312-2015·2015-05-27

    Bridge City Baking Recalls Gluten-Free Apple Crumble Pies for Undeclared Milk

    Bridge City Baking is recalling frozen gluten-free apple crumble pies because butter is listed without its sub-ingredient, milk.

    Product
    BRIDGE CITY Baking gluten free Apple Crumble Pie. This product is frozen ready to bake. Net Wt 24oz UPC 0 91037 54453 7 Label is orange and maroon with black, white and orange lettering.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2283-2015·2015-05-27

    Fetting's Cinnamon Roll Dough Recalled for Missing Soy Ingredient Label

    Top Taste, Inc. is recalling Fetting's Jumbo Cinnamon Roll Dough because the packaging failed to list defatted soy flour as an ingredient.

    Product
    Fetting's Jumbo 2.5 oz Cinnamon Roll Dough 140, Approx. 120 count, Keep Frozen, NET WT 18.8 LB., UPC 0 75812 79140 0, Packaged in plastic liner in cardboard box, Manufactured by Top Taste Inc, Finley, ND 58230..
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1642-2015·2015-05-27

    DeRoyal Specimen Retrieval Bags Recalled for Tearing During Use

    DeRoyal Industries is recalling 5,359 Medium Specimen Retrieval Bags because they may tear or come apart during laparoscopic procedures.

    Product
    DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2311-2015·2015-05-27

    Bridge City Baking Recalls Gluten-Free Cherry Crumble Pies for Undeclared Milk

    Bridge City Baking LLC is recalling frozen gluten-free Cherry Crumble Pies because butter is listed without its sub-ingredient, milk.

    Product
    BRIDGE CITY Baking gluten free Cherry Crumble Pie. This product is frozen ready to bake. Net Wt 24oz UPC 0 91037 54455 1
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1629-2015·2015-05-27

    Siemens IMMULITE TBG Test Kits Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling 155 IMMULITE TBG test kits because they may produce falsely low thyroid test results.

    Product
    IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1640-2015·2015-05-27

    Richard-Allan Scientific Recalls Mucolexx Mucolytic Agent Due to Fungal Contamination

    Richard-Allan Scientific is recalling Mucolexx mucolytic agent and Mucolexx products after a customer reported fungal contamination in two lots.

    Product
    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2015·2015-05-27

    Baxter ABACUS Software Recalled for Potential TPN Formula Loading Errors

    Baxter is recalling ABACUS SE and ME software because it may load incorrect total parenteral nutrition formulas when duplicate order numbers are used.

    Product
    ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1626-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 124 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1627-2015·2015-05-27

    Wright Medical Recalls PHALINX Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 126 units of PHALINX Hammertoe Handles because the term 'DORSAL' was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1636-2015·2015-05-27

    MelaFind Device Recalled for Unapproved User Interface Data Display

    MELA Sciences is recalling 65 MelaFind devices because the probability and histogram data displayed in the user interface lacks FDA approval.

    Product
    MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1554-2015·2015-05-27

    Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal

    Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.

    Product
    Philips Healthcare DigitalDiagnost System X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1619-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speakers may malfunction.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1632-2015·2015-05-27

    Philips EPIQ 7 Ultrasound System Recalled for Unit Conversion Error

    Philips is recalling EPIQ 7 Ultrasound Systems due to a unit conversion error that may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201 Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 4
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1621-2015·2015-05-27

    bioMerieux MYLA Server Software Recalled for Processing Failures

    bioMerieux is recalling MYLA V3 server software because it may stop processing data in high-volume settings, requiring remote or on-site service.

    Product
    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1618-2015·2015-05-27

    Integra Recalls Camino ICP Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.

    Product
    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1625-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handle Due to Incorrect Etching

    Wright Medical Technology is recalling 121 units of Phalinx Hammertoe Handles because the word 'DORSAL' was laser-etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2015·2015-05-27

    Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects

    Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2301-2015·2015-05-27

    La Fe Green Hot Sauce Recalled for Undeclared Food Dyes

    Le Fe Foods, Inc. is recalling La Fe Green Hot Sauce because it contains undeclared FD & C Blue #1 and FD & C Yellow #5.

    Product
    La Fe Green Hot Sauce, 5.6 Fl. Oz. - 165 mL, Imported by: G & T Foods, Inc., Moonachie, N.J. 07074, Distributed by: LA FE Foods, Product of Columbia, UPC 023545211052
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1635-2015·2015-05-27

    Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues

    Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2015·2015-05-27

    Stryker Scorpio femoral component recall due to blister seal strength

    Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.

    Product
    Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2015·2015-05-27

    Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep

    Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.

    Product
    Philips Healthcare DuraDiagnost X- Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1620-2015·2015-05-27

    Integra Recalls Camino and Licox Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP and Licox PtO2 monitors because the audible speaker malfunctions.

    Product
    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1084-2015·2015-05-27

    Oasis Medical Recalls ImproVue Ophthalmic Lubricant Drops for pH Failure

    Oasis Medical is recalling specific lots of ImproVue Ophthalmic Lubricant Drops because they failed to meet pH specifications.

    Product
    ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1624-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 126 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1630-2015·2015-05-27

    CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect

    CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.

    Product
    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2015·2015-05-27

    Mylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels

    Mylan Institutional, Inc. is recalling 1,363 cartons of Fexofenadine Hydrochloride 60 mg tablets because routine stability testing showed slightly above specification results for a related compound.

    Product
    Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalNHTSA·15V313000·2015-05-26

    Chrysler Recalls Vehicles Due to Driver Air Bag Inflator Rupture Risk

    Chrysler is recalling specific 2004-2011 Dodge, Chrysler, and Mitsubishi vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    MITSUBISHI — MITSUBISHI, DODGE, CHRYSLER RAIDER, CHARGER, DURANGO, ASPEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V310000·2015-05-26

    PACCAR Recalls Kenworth and Peterbilt Trucks for Driveshaft Weld Failure

    PACCAR is recalling specific Kenworth and Peterbilt trucks because a driveshaft weld may fail due to corrosion, potentially causing loss of power to the rear wheels.

    Product
    KENWORTH — KENWORTH, PETERBILT T680, 587, T660, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V312000·2015-05-26

    Dodge Ram Trucks Recalled for Air Bag Inflator Rupture Risk

    Chrysler is recalling 2003 Dodge Ram trucks because the passenger air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    DODGE — DODGE RAM 3500, RAM 2500, RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V309000·2015-05-26

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Fire Risk

    PACCAR is recalling specific Kenworth and Peterbilt trucks because a vent tube may detach, allowing engine oil to contact hot surfaces and cause a fire.

    Product
    PETERBILT — PETERBILT, KENWORTH 365, 384, 348, 382
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V308000·2015-05-26

    Open Range Recalls 2015 Fifth Wheel Trailers Due to Step Rivet Failure

    Open Range R.V. Company is recalling 122 model year 2015 Roamer, Mesa Ridge, and 3X fifth wheel trailers because a rivet on the entry steps may shear, causing the steps to fail.

    Product
    OPEN RANGE — OPEN RANGE 3X, ROAMER, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15148·2015-05-26

    Gerber Recalls Cohort Folding Knives Due to Laceration Hazard

    Gerber is recalling Cohort folding knives because the locking mechanism can fail, posing a laceration hazard. Six injuries have been reported.

    Product
    Cohort Folding Knife
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15149·2015-05-26

    BRP Recalls Youth Can-Am ATVs for Federal Standard Violations

    Bombardier Recreational Products is recalling about 12,500 youth Can-Am ATVs because they fail to meet federal speed and parking brake requirements, posing a crash hazard.

    Product
    All-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V307000·2015-05-26

    Collins Recalls 2015 School Buses for Seat Flammability Defect

    Collins Bus Corporation is recalling 13 model year 2015 school buses because seat foam may not meet federal flammability standards, increasing fire risk.

    Product
    COLLINS — COLLINS DH500, SH40, SL408, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E044000·2015-05-22

    MACVAD Recalls Auto XS Heated Seat Covers Due to Overheating Risk

    MACVAD is recalling Auto XS Heated Seat Covers manufactured between August and September 2014 because they may overheat and melt, posing injury or fire risks.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·083-2015·2015-05-22

    Culinary Brands Recalls Pork Chile Verde for Undeclared Wheat Allergen

    Culinary Brands Inc. is recalling approximately 4,038 pounds of Simply Balanced Pork Chile Verde due to misbranding and an undeclared wheat allergen.

    Product
    Ruiz Food Products, Inc. — Culinary Brands Inc. Recalls Pork Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·082-2015·2015-05-22

    Old World Meats Recalls Roast Beef for Undeclared Soy Allergen

    Old World Meats is recalling approximately 12 pounds of roast beef products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Old World Meat — Old World Meats Recalls Roast Beef Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·15V302000·2015-05-22

    Open Range Residential Fifth Wheel Trailers Recalled for Gas Line Defect

    Open Range is recalling 2013-2014 Residential 417RS fifth wheel trailers because a short gas line may leak when the kitchen slideout is expanded, increasing fire risk.

    Product
    OPEN RANGE — OPEN RANGE RESIDENTIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V304000·2015-05-22

    Highland Ridge RV Recalls 2015 Fifth Wheel Trailers Due to Step Rivet Failure

    Highland Ridge RV is recalling 2015 Roamer and Mesa Ridge fifth wheel trailers because a rivet on the quad entry steps may shear, causing the steps to give and increasing the risk of injury.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT MESA RIDGE, ROAMER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15733·2015-05-21

    Vivint Recalls Remotec Dimming Switch Modules Due to Shock Hazard

    Vivint is recalling Remotec ZDS-100US dimming switch modules because incorrect wiring poses a shock hazard. Consumers should destroy the product as the recall remedy is no longer available.

    Product
    Dimming switch modules
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15145·2015-05-21

    OXO Recalls Nest Booster Seats Due to Fall Hazard

    OXO is recalling Nest Booster Seats because stitching on the restraint straps can loosen, allowing the straps to separate from the seat and posing a fall hazard to children.

    Product
    Nest Booster Seat
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2186-2015·2015-05-20

    Trader Joe's Raw Walnuts Recalled for Potential Salmonella Contamination

    Trader Joe's is recalling specific lots of raw California walnuts due to potential Salmonella contamination. Consumers should check their packages for the listed UPCs and lot numbers.

    Product
    Trader Joe's Nuts Raw California Walnut Pieces NET WT. 16oz. (1 LB) 454g UPC 00373685 Trader Joe's Nuts Raw California Walnut Halves & Pieces NET WT. 16 OZ (1 LB) 454g UPC 00943338 Trader Joe's Nuts Raw California Walnut Baking Pieces NET WT. 16 OZ (1 LB) 454g UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2270-2015·2015-05-20

    Santa Barbara Smokehouse Recalls Smoked Salmon for Listeria Risk

    The Santa Barbara Smokehouse is recalling specific batches of smoked salmon after testing positive for Listeria monocytogenes, an organism that can cause serious infections.

    Product
    Cambridge House Balmoral Thinly Sliced Exceptional Ready to Enjoy Smoked Salmon Keep Refrigerated at 38 or below Ingredients Atlantic Salmon, Salt, Sugar, and Oakwood Smoke Produced By: The Santa Barbara Smokehouse 312 N. Nopal Santa Barbara, CA 93103 www.sbsmokehouse.
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2244-2015·2015-05-20

    Whole Foods Recalls Falafel Due to Undeclared Peanut Protein

    Whole Foods Market is recalling 950 pounds of Vegetarian, NEW Falafel because it contains undeclared peanut protein. The product was distributed in 13 states and the District of Columbia.

    Product
    Vegetarian, NEW Falafel UPC/PLU: 48000025248
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2265-2015·2015-05-20

    Aurora Products Recalls Roasted Mixed Nuts Due to Salmonella Risk

    Aurora Products, Inc. is voluntarily recalling specific lots of Roasted Mixed Nuts No Salt because they may be contaminated with Salmonella.

    Product
    Roasted Mixed Nuts No Salt: Gourmet Garage, 9 oz. Plastic Cup, UPC: 79084506010; Hannaford, 9.0 oz. Plastic Cup, UPC: 72543994507
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2266-2015·2015-05-20

    Aurora Recalls San Fernando Sunshine Mix Due to Salmonella Risk

    Aurora Products, Inc. is recalling 84 pounds of San Fernando Sunshine Mix due to a potential Salmonella hazard. The product was distributed in the US, Canada, and Bermuda.

    Product
    San Fernando Sunshine Mix: Gourmet Garage, 11 oz. Plastic Cup, UPC: 79084505936
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2258-2015·2015-05-20

    Aurora Products Recalls Walnuts Due to Salmonella Risk

    Aurora Products, Inc. is voluntarily recalling approximately 23,757 pounds of walnuts in various retail brands due to a potential Salmonella contamination risk.

    Product
    Walnuts: America Choice, 12 oz. Plastic Pouch, UPC: 75480779049; Aurora , 6.5 oz. Plastic Cup, UPC: 65585200097; Aurora, 14.0 oz. Plastic Tub, UPC: 65585200070; Aurora, Bulk, NO UPC; Aurora, 4.0 oz. Plastic Pouch, UPC: 65585200490; Aurora, 12.0 oz. Plastic Pouch, UPC: 65585200316
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2264-2015·2015-05-20

    Aurora Products Recalls Raisin Nut Party Mix Due to Salmonella Risk

    Aurora Products, Inc. is recalling Raisin Nut Party Mix products due to a potential Salmonella contamination. The recall covers specific brands and sizes distributed in the US, Canada, and Bermuda.

    Product
    Raisin Nut Party Mix: Aurora, 11.0 oz. Plastic Cup, UPC: 65585200094; Ernest Klein, 11.0 oz. Plastic Cup, UPC: 65585200094, Food Emporium Brand Products, 7.5 oz. Gift Bag, UPC: 1119079050; Gauls Market Brand Products, 11.0 oz. Plastic Cup, UPC: 65585200094; Harvest Co Op Market,
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2263-2015·2015-05-20

    Aurora Forest Bounty Grail Mix Recalled for Salmonella Risk

    Aurora Products is recalling Forest Bounty Grail Mix due to a potential Salmonella contamination risk. The recall covers specific 13 oz and 17.5 oz packages distributed in the US, Canada, and Bermuda.

    Product
    Forest Bounty Grail Mix: Aurora, 13 oz. Plastic Cup, UPC: 65585200571; Aurora, 13 oz. Plastic Pouch, UPC: 65585200290; Aurora, 17.5 oz. Plastic Cup, UPC: 65585200496
    Category
    Food
    Distribution
    Distributed nationwide

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