The Recall Desk

Archive

September 2017 recalls

342 recalls were announced in September 2017.

What the numbers show

Critical
24
Severe
115
High
101
Moderate
92
Low
10

Of the 342 recalls this month scored against our rubric, 7% are Critical, 34% are Severe.

Which agencies issued them

201–300 of 342

  • LowFDA (Devices)·Z-3132-2017·2017-09-20

    Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records

    Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.

    Product
    FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they c
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1139-2017·2017-09-20

    VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Labeling Error

    VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the product was incorrectly labeled as a Class III controlled substance instead of a Class II controlled substance.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·17V574000·2017-09-19

    Mercedes-Benz Recalls Four 2017 Models for Steering Defect

    Mercedes-Benz is recalling four 2017 vehicles due to improperly welded steering pins that may disable power assist, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E300, AMG E43, GLC300, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·102-2017·2017-09-17

    German Sausage Haus Recalls Meat Products Due to Staphylococcal Enterotoxin Risk

    German Sausage Haus is recalling approximately 1,252 pounds of frozen meat products due to a possible processing deviation that may have led to staphylococcal enterotoxin contamination.

    Product
    German Sausage Haus, LLC, Recalls Meat Products Due To Possible Processing Deviation and Staphylococcal Enterotoxin Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17E051000·2017-09-17

    Curt Trailer Hitches Recalled for Mini Clubman and Countryman Models

    Curt Manufacturing is recalling Class 1 trailer hitches for 2016-2018 Mini Clubman and Countryman vehicles because the mounting points may be inadequate, causing the hitch to sag or separate.

    Product
    MINI — MINI CLUBMAN, COUNTRYMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V573000·2017-09-15

    Forest River Recalls Vibe and Rainier Trailers for Propane Line Defect

    Forest River is recalling 2015-2018 Vibe and 2016-2018 Rainier recreational trailers because the liquid propane line may have insufficient clearance, posing a fire risk.

    Product
    FOREST RIVER — FOREST RIVER VIBE, RAINIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V571000·2017-09-15

    Nissan Recalls 2017 Infiniti Q50 Vehicles for Air Bag Inflator Defect

    Nissan is recalling 2017 Infiniti Q50 and Q50 Hybrid vehicles because the driver's air bag inflator may be improperly welded, increasing injury risk in a crash.

    Product
    INFINITI — INFINITI Q50 HYBRID, Q50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·101-2017·2017-09-15

    Sausage Products Recalled for Undeclared Milk Allergen and Misbranding

    America New York RI Wang Food Group is recalling pork sausage products containing undeclared milk. The recall covers approximately 53,973 pounds distributed in New Jersey and New York.

    Product
    America New York RI Wang Food Group Recalls Sausage Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V565000·2017-09-14

    Kimble Mixer Recalls 2014 Custom Chassis for Drive Axle Defect

    Kimble Mixer is recalling one 2014 Mixer Custom Chassis because improperly torqued hex nuts on the drive axle could cause the driveshaft to disconnect, increasing crash risk.

    Product
    KIMBLE — KIMBLE MIXER CUSTOM CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V570000·2017-09-14

    Pierce Recalls 2015-2016 Vehicles for Steering Tie Rod Torque Defect

    Pierce Manufacturing is recalling 2015-2016 Arrow XT, Enforcer, Impel, Quantum, Saber, and Velocity vehicles because a steering axle nut may not be properly torqued, risking loss of steering.

    Product
    PIERCE — PIERCE IMPEL, ARROW XT, ENFORCER, SABER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V569000·2017-09-14

    Mitsubishi Recalls Lancer Vehicles Due to Air Bag Inflator Rupture Risk

    Mitsubishi is recalling 2004-2006 Lancer and 2004 Lancer Sportback vehicles because the passenger air bag inflator may rupture in a crash, potentially causing serious injury or death.

    Product
    MITSUBISHI — MITSUBISHI LANCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17C003000·2017-09-14

    Diono Recalls Multiple Convertible and Booster Car Seats for Crash Protection Defect

    Diono is recalling specific Radian, Olympia, Pacifica, and Rainier car seats manufactured between late 2013 and early 2017. The seats may not adequately protect children from chest injuries in crashes if installed forward-facing with only a lap belt.

    Product
    CHILD SEAT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17224·2017-09-14

    Southwire Recalls Moonrays Globe Stake Lights Due to Fire Hazard

    Southwire is recalling Moonrays mystic globe and snow globe stake lights because light refraction can singe or melt nearby items, posing a fire hazard.

    Product
    Moonrays mystic globe and snow globe stake lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V567000·2017-09-14

    GM Recalls 2017-2018 Silverado and Sierra Trucks for Seat Belt Defect

    General Motors is recalling 2017-2018 Chevrolet Silverado and GMC Sierra trucks because front seat belt retractors may not perform correctly in a crash.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SIERRA 2500, SILVERADO 3500, SILVERADO 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3514-2017·2017-09-13

    Litehouse OPA Ranch Dressing Recalled for Undeclared Egg

    Litehouse Inc. is recalling OPA by Litehouse Ranch Greek Yogurt Dressing due to undeclared egg. The product was distributed in seven states.

    Product
    OPA by Litehouse Ranch, 6/11.25 oz. glass round bottles per case. The retail label listed item #48246 and has the UPC 0 77661 15022 1. The UPC on master case outer label is 01 1 0077661 13948 3. The recalled product's retail label is read in parts: "***OPA BY LITEHOUSE
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-3538-2017·2017-09-13

    Shore Lunch Fish Breading Batter Mix Recalled for Salmonella Risk

    Southeastern Mills is recalling Shore Lunch Fish Breading Batter Mix because raw buttermilk solids may be contaminated with Salmonella.

    Product
    Shore Lunch, Fish Breading Batter Mix, Original Breading, Net Wt. 3.5 lbs. (1587g) and12/255 G (Canada).
    Category
    Food
    Distribution
    34 states
  • CriticalFDA (Food)·F-3537-2017·2017-09-13

    Southeastern Mills Cheddar Garlic Biscuit Mix Recalled for Salmonella Risk

    Southeastern Mills is recalling Easy Drop Cheddar Garlic Drop Biscuit Mix because raw buttermilk solids may be contaminated with Salmonella.

    Product
    Southeastern Mills, Easy Drop Cheddar Garlic Drop Biscuit Mix, Net Wt. 7oz (198g).
    Category
    Food
    Distribution
    34 states
  • SevereFDA (Food)·F-3532-2017·2017-09-13

    United Trading Recalls Gazab Green Raisins for Undeclared Sulfites

    United Trading Inc. is voluntarily recalling Gazab Green Raisins due to undeclared sulfites. The product was distributed in seven states.

    Product
    Gazab Green Raisins, 7 oz. 14 oz. packages, 20/25 packs/carton
    Category
    Food
    Distribution
    7 states
  • SevereCPSC·17223·2017-09-13

    Target Recalls Room Essentials 4-Drawer Dressers for Tip-Over Hazards

    Target is recalling approximately 175,000 Room Essentials 4-drawer dressers due to tip-over and entrapment hazards that can result in death or injuries to children.

    Product
    Room Essentials 4-drawer dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V566000·2017-09-13

    AEV Traumahawk Ambulances Recalled for Door Striker Bolt Failure

    Halcore Group is recalling 2016-2017 AEV Traumahawk ambulances because door striker bolts may fail under load, potentially allowing doors to open in a crash.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3086-2017·2017-09-13

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects

    Maquet Datascope is recalling 14,547 CS 100 Intra-Aortic Balloon Pumps worldwide due to a defect that could prevent therapy initiation or continuation.

    Product
    CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1133-2017·2017-09-13

    ImprimisRx Recalls Timolol Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling compounded Timolol ophthalmic drops because they were made with non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    Product
    Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1130-2017·2017-09-13

    ImprimisRx Recalls Curcumin Emulsion Injection Due to Undeclared Excipient

    ImprimisRx is recalling Curcumin Emulsion 10mg/ml Injection vials because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    Product
    Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V563000·2017-09-13

    Cruiser RV Recalls 2018 Shadow Cruiser Ultra Lite Trailers for Axle Defect

    Cruiser RV is recalling 2018 Shadow Cruiser Ultra Lite trailers because rear axles were installed backwards, potentially reducing braking ability or causing brakes to lock up.

    Product
    CRUISER RV — CRUISER RV SHADOW CRUISER ULTRA LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3110-2017·2017-09-13

    Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error

    Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.

    Product
    MOSAIQ Medical Charged-Particle Radiation Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3112-2017·2017-09-13

    Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results

    Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.

    Product
    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3085-2017·2017-09-13

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress

    Maquet Datascope is recalling 14,547 CS 100i Intra-Aortic Balloon Pumps because fluid ingress and false alarms could prevent therapy.

    Product
    CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3087-2017·2017-09-13

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk

    Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps because fluid ingress could damage electronic boards, potentially preventing therapy initiation or continuation.

    Product
    CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V564000·2017-09-13

    Heartland Recalls 2018 Sundance XLT TT Trailers Due to Axle Defect

    Heartland is recalling 2018 Sundance XLT TT recreational trailers because rear axles were installed backwards, which may reduce braking ability or cause brakes to lock up.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3103-2017·2017-09-13

    MicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination

    MicroVention is recalling 34 units of Traxcess 7 Mini Guidewires because the hydrophilic coating may delaminate from the device.

    Product
    MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-3107-2017·2017-09-13

    Cardinal Health Recalls Presource Kits Contaminated with Needle Particulate

    Cardinal Health is recalling Presource surgical kits because they contained BD SafetyGlide needles with loose polypropylene particulate in the fluid path.

    Product
    Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3105-2017·2017-09-13

    Merge Unity Software Recall for Incorrect Gail Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3113-2017·2017-09-13

    Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.

    Product
    Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3114-2017·2017-09-13

    Beckman Coulter HmX Analyzers Recalled for Potential Blast Detection Failure

    Beckman Coulter is recalling HmX CP and HmX AL analyzers because they may fail to flag or detect blasts in rare blood sample situations.

    Product
    Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3104-2017·2017-09-13

    Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure

    Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.

    Product
    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-3533-2017·2017-09-13

    Madhava Chocolate Chip Cookie Mix Recalled for Undeclared Milk

    Madhava Honey Ltd is recalling its Chocolate Chip Cookie Mix because it may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Madhava Naturally Sweet Deliciously Organic MMM... Chocolate Chip Cookie Mix,, 13.8 oz. , UPC 0 78314 25105 0. Packaged in box, 6 packages per case, Ambient storage.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3108-2017·2017-09-13

    CryoLife On-X Heart Valve Recall Due to Device Mix-Up

    CryoLife is recalling five On-X Prosthetic Heart Valves because a return authorization error caused them to be redistributed and implanted in two patients.

    Product
    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic di
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-3487-2017·2017-09-13

    Rushing Waters Fisheries Recalls Smoked Whitefish Fillet for Underprocessing

    Rushing Waters Fisheries is recalling smoked whitefish fillets because they may have been underprocessed. The product was distributed in Illinois.

    Product
    Whole Foods Smoked Whitefish Fillet, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-3485-2017·2017-09-13

    Rushing Waters Recalls Smoked Atlantic Salmon Portions for Underprocessing

    Rushing Waters Fisheries is recalling Smoked Peppered Atlantic Salmon Portions because they may have been underprocessed. The product was distributed in Illinois.

    Product
    Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box var
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1131-2017·2017-09-13

    ImprimisRx Recalls Latanoprost Ophthalmic Drops Due to Undeclared Excipient

    ImprimisRx is recalling 19 bottles of compounded Latanoprost ophthalmic drops because they contain non-pharmaceutical grade PEG 40 Castor Oil due to supplier mislabeling.

    Product
    Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1129-2017·2017-09-13

    Povidone Iodine Solution Recalled for Labeling Error

    Degasa Sa De Cv is recalling 720 bottles of Povidone Iodine 10% solution due to a label mix-up where 7.5% product was labeled as 10%.

    Product
    Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1132-2017·2017-09-13

    ImprimisRx Recalls Timolol-Latanoprost Ophthalmic Drops Due to Mislabeling

    ImprimisRx is recalling 16 bottles of compounded Timolol-Latanoprost ophthalmic drops because non-pharmaceutical grade PEG 40 Castor Oil was used due to supplier mislabeling.

    Product
    Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3486-2017·2017-09-13

    Rushing Waters Fisheries Recalls Smoked Atlantic Salmon Portions

    Rushing Waters Fisheries is recalling smoked Atlantic salmon portions because they may have been underprocessed.

    Product
    Whole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-1128-2017·2017-09-13

    McKesson Recalls Propafenone Hydrochloride Tablets for Moisture Content Issues

    McKesson Packaging Services is recalling Propafenone Hydrochloride tablets due to failed moisture limits. The affected units were distributed to five states.

    Product
    Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-1127-2017·2017-09-13

    Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·17V562000·2017-09-12

    RAM Trucks Recalled for Water Pump Leak Fire Risk

    Chrysler is recalling 2013-2017 RAM trucks with specific Cummins diesel engines because a water pump defect may leak coolant and increase the risk of an engine compartment fire.

    Product
    RAM — RAM 5500, 4500, 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V561000·2017-09-12

    Highland Ridge Recalls 2018 Open Range 3X Trailers for Tire Labeling

    Highland Ridge RV is recalling 2018 Open Range 3X fifth wheel trailers because tire size labels may be incorrect, potentially leading to the installation of wrong-sized tires.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW OPEN RANGE 3X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17T015000·2017-09-11

    Trek Tire Recalls Dunlop GrandTrek PT3A Tires for Missing DOT Markings

    Trek Tire is recalling specific Dunlop GrandTrek PT3A tires manufactured in December 2016 because they lack complete DOT identification markings, which may increase crash risk.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·100-2017·2017-09-08

    Northside Noodle Company Recalls Meatball Mix Due to Undeclared Soy Allergen

    Northside Noodle Company is recalling approximately 123 pounds of frozen meatball mix because the product contains soy, a known allergen, that is not declared on the label.

    Product
    Northside Noodle Co — Northside Noodle Company Recalls Meatball Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighCPSC·17222·2017-09-08

    Nantucket Distributing Recalls Bimini Patio Set Chairs Due to Fall Hazard

    Nantucket Distributing is recalling Bimini patio set chairs because the fabric seat can tear, posing a fall hazard. Consumers should stop using the chairs and return them for a refund.

    Product
    Chairs sold with Bimini patio sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V558000·2017-09-08

    Micro Bird Recalls 2016 G5 School Buses for Seat Safety Defect

    Micro Bird is recalling 25 units of 2016 G5 school buses because seat mounting studs may lack adequate padding, increasing injury risk in rear-end collisions.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V557000·2017-09-07

    Eldorado Axess Transit Buses Recalled for Front Suspension Defect

    Eldorado is recalling 2015 Axess transit buses because front suspension link rod clamps may not be properly torqued, which can loosen the link rod and decrease steering ability.

    Product
    ELDORADO — ELDORADO AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E050000·2017-09-07

    J-Tech Recalls Icon Alliance Motorcycle Helmets Due to Chin Strap Defect

    J-Tech is recalling specific Icon Alliance motorcycle helmets because faulty stitching may allow the chin strap to separate, increasing injury risk in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17220·2017-09-07

    Studio Fun International Recalls Slap Bracelets Sold with Storybooks

    Studio Fun International is recalling slap bracelets sold with DreamWorks Trolls storybooks because the metal band can wear through the fabric, posing a laceration hazard.

    Product
    Bracelets sold with storybooks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V555000·2017-09-07

    Thor Motor Coach Recalls 2014-2016 Motorhomes for Wiper Defect

    Thor Motor Coach is recalling 2014-2016 motorhomes because windshield wipers may fail due to incorrect installation, increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR, THOR MOTOR TUSCANY XTE, DAYBREAK, ACE, MIRAMAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V556000·2017-09-07

    KZRV Recalls 2017-2018 Trailers Due to Missing Awning Light Fuse

    KZRV is recalling 2017-2018 Connect, Spree, and Sport Trek trailers because a missing fuse in the awning light circuit may cause wire overheating and fire.

    Product
    KZRV — KZRV CONNECT, SPREE, SPORT TREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3477-2017·2017-09-06

    Amrita Pineapple Chia Energy Bar Recalled for Listeria Contamination

    Amrita Health Foods is recalling Pineapple Chia Energy Bars due to potential Listeria monocytogenes contamination. Consumers should check their pantry for affected products.

    Product
    Amrita Pineapple Chia Energy Bar, 50gm UPC: 853009004025
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3476-2017·2017-09-06

    Amrita Apricot Strawberry Protein Bar Recalled for Listeria Contamination

    Amrita Health Foods is recalling Apricot Strawberry Protein Bars due to potential Listeria monocytogenes contamination. Consumers should check best-by dates and discard affected products.

    Product
    Amrita Apricot Strawberry Protein Bar, 50gm UPC :853009004056
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3481-2017·2017-09-06

    AGROSONS LLC Recalls Papayas Maradol cavi Due to Salmonella Contamination

    AGROSONS LLC is recalling Papayas Maradol cavi grown and packed by CARICA DE CAMPECHE due to potential Salmonella contamination. The product was distributed in New York, Connecticut, and New Jersey.

    Product
    Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRIBUTED BY: AGROSONS LLC
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-3462-2017·2017-09-06

    Health Warrior Chia Bars Recalled for Listeria Risk

    Belmont Confections Inc. is recalling Health Warrior Chia Bars due to potential Listeria monocytogenes contamination in an ingredient.

    Product
    HEALTH WARRIOR CHIA BAR VANILLA ALMOND NT WT 25 g (.88 g) ALLERGENS: Contains
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-3478-2017·2017-09-06

    Amrita Apple Cinnamon Energy Bar Recalled for Listeria Contamination

    Amrita Health Foods is recalling 115,000 Apple Cinnamon Energy Bars nationwide due to potential Listeria monocytogenes contamination.

    Product
    Amrita Apple Cinnamon Energy Bar, 50gm UPC: 853009004049
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3471-2017·2017-09-06

    Amrita Chocolate Maca Protein Bar Recalled for Listeria Contamination Risk

    Amrita Health Foods is recalling Amrita Chocolate Maca 15g Protein Bars due to potential Listeria monocytogenes contamination. Consumers should check best-by dates and stop eating the product.

    Product
    Amrita Chocolate Maca 15g Protein Bar, 60 gm UPC: 853009004056
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3466-2017·2017-09-06

    Carla's Pasta Basil Pesto Sauce Recalled for Listeria Contamination

    Carla's Pasta, Inc. is recalling Basil Pesto Sauce due to potential Listeria monocytogenes contamination. The product was distributed in Wisconsin.

    Product
    CARLA'S PASTA, INC. BASIL PESTO SAUCE: BULK, Mfd. Date 06/20/17, KEEP FROZEN NET WT. 13.40 LBS (6.08 kg) 00021605014209
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-3483-2017·2017-09-06

    Fresh Tex Produce Recalls Valery Brand Maradol Papayas Due to Salmonella Risk

    Fresh Tex Produce is recalling Valery Brand Maradol Papayas because they were sourced from a grower linked to a Salmonella outbreak.

    Product
    Valery Brand Maradol Papayas sold fresh in 35 pound boxes. Labeled grown and packed by Carica de Campeche
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-3467-2017·2017-09-06

    Grande Produce Recalls Papaya Cases Due to Salmonella Contamination

    Grande Produce is recalling 5,344 cases of Caribena yellow maradol papaya nationwide because the product is contaminated with Salmonella.

    Product
    Caribena yellow maradol papaya packed in 35 pound cases
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3464-2017·2017-09-06

    Belmont Confections Recalls ISS ONE Protein Bars Due to Listeria Risk

    Belmont Confections Inc is recalling ISS ONE Salted Caramel Flavored Protein Bars because an ingredient used in their manufacture was recalled due to potential Listeria monocytogenes contamination.

    Product
    ISS ONE Salted Caramel Flavored Protein Bar NET WT 2012 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin). This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·17V553000·2017-09-06

    Seagrave Aerialscope Recall: Loose Tie Rods May Cause Loss of Steering

    Seagrave is recalling 2017 Aerialscope emergency vehicles because improperly torqued steer axle nuts may allow tie rods to loosen, risking a complete loss of steering.

    Product
    SEAGRAVE — SEAGRAVE AERIALSCOPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V554000·2017-09-06

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Steering Defect

    PACCAR is recalling specific Kenworth and Peterbilt trucks because a front axle sway bar link may detach and bind the steering system, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 220, K370, 210, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3475-2017·2017-09-06

    Amrita Mango Coconut Energy Bar Recalled for Listeria Contamination

    Amrita Health Foods is recalling 115,000 Mango Coconut Energy Bars nationwide due to potential Listeria monocytogenes contamination.

    Product
    Amrita Mango Coconut Energy Bar, 50gm UPC: 853009004018
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3473-2017·2017-09-06

    Amrita Sunflower Butter & Jelly Protein Bar Recalled for Listeria Risk

    Amrita Health Foods is recalling Sunflower Butter & Jelly 15g Protein Bars due to potential Listeria monocytogenes contamination.

    Product
    Amrita Sunflower Butter & Jelly 15g Protein Bar, 60gm UPC: 853009004414
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·17217·2017-09-06

    Ameriwood Recalls Mainstays Chests of Drawers for Tip-Over Hazards

    Ameriwood Home is recalling about 1.6 million Mainstays chests of drawers because they can tip over or entrap children if not anchored to the wall.

    Product
    Mainstays chests of drawers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3472-2017·2017-09-06

    Amrita Dark Chocolate Quinoa Protein Bar Recalled for Listeria Risk

    Amrita Health Foods is recalling Dark Chocolate Quinoa 15g Protein Bars due to potential Listeria monocytogenes contamination.

    Product
    Amrita Dark Chocolate Quinoa 15g Protein Bar, 60gm UPC: 853009004438
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3072-2017·2017-09-06

    Medspira mcompass Balloon Catheters Recalled for Potential Separation

    Medspira is recalling mcompass 2-channel Balloon Catheters because the balloon may separate from the inner stem and remain in the rectal cavity.

    Product
    mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate a
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-3458-2017·2017-09-06

    Health Warrior Chia Bar Acai Berry Recalled for Listeria Risk

    Belmont Confections Inc. is recalling Health Warrior Chia Bar Acai Berry products due to a potential for Listeria monocytogenes contamination in an ingredient.

    Product
    HEALTH WARRIOR CHIA BAR ACAI BERRY NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-3479-2017·2017-09-06

    Amrita Cranberry Raisin Energy Bar Recalled for Listeria Contamination

    Amrita Health Foods is recalling Cranberry Raisin Energy Bars due to potential Listeria monocytogenes contamination. Consumers should check best-by dates and discard affected products.

    Product
    Amrita Cranberry Raisin Energy Bar, 50gm UPC: 853009004032
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3459-2017·2017-09-06

    Health Warrior Chia Bar Apple Cinnamon Recalled for Listeria Risk

    Belmont Confections Inc is recalling Health Warrior Chia Bar Apple Cinnamon due to potential Listeria monocytogenes contamination in an ingredient.

    Product
    HEALTH WARRIOR CHIA BAR APPLE CINNAMON NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews and Almonds)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-3461-2017·2017-09-06

    Belmont Confections Recalls Health Warrior Chia Bars Due to Listeria Risk

    Belmont Confections Inc is recalling Health Warrior Chia Bar Dark Chocolate products because an ingredient used in their manufacture was recalled for potential Listeria monocytogenes contamination.

    Product
    HEALTH WARRIOR CHIA BAR DARK CHOCOLATE NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews). Produced on equipment that also processes other tree nuts, peanuts, soy, wheat and milk.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-3463-2017·2017-09-06

    Belmont Confections Recalls ISS ONE Protein Bars for Listeria Risk

    Belmont Confections Inc is recalling ISS ONE Blueberry Cobbler Protein Bars due to potential Listeria monocytogenes contamination in an ingredient.

    Product
    ISS ONE Blueberry Cobbler Flavored Protein Bar NET WT 2.12 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin), This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-3474-2017·2017-09-06

    Amrita Chocolate Chip Coconut Protein Bar Recalled for Listeria Risk

    Amrita Health Foods is recalling 115,000 Chocolate Chip Coconut 15g Protein Bars nationwide due to potential Listeria monocytogenes contamination.

    Product
    Amrita Chocolate Chip Coconut 15g Protein Bar, 60gm UPC: 853009004391
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3460-2017·2017-09-06

    Belmont Confections Recalls Health Warrior Chia Bars for Listeria Risk

    Belmont Confections Inc is recalling Health Warrior Chia Bar Coconut products due to a potential for Listeria monocytogenes contamination in an ingredient.

    Product
    HEALTH WARRIOR CHIA BAR COCONUT NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews, Coconut)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2811-2017·2017-09-06

    Michele's Toasted Muesli Recalled for Potential Listeria Contamination

    Michele's Granola LLC is recalling 16 oz bags of Toasted Muesli due to potential Listeria monocytogenes contamination. The product was distributed to retail grocery stores in several states.

    Product
    Michele s Toasted Muesli, 16 oz bags, 12 units per case
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·17V549000·2017-09-06

    Keystone Recalls 2016-2018 Springdale and Summerland Trailers for Wiring Fire Risk

    Keystone RV Company is recalling 2016-2018 Springdale and Summerland recreational trailers because incorrectly connected wiring for electric stabilizer jacks can cause an electrical short and increase the risk of fire.

    Product
    KEYSTONE — KEYSTONE SUMMERLAND, SPRINGDALE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3480-2017·2017-09-06

    Schnucks Bakery German Chocolate Cakes Recalled for Unlabeled Pecans

    Schnucks Markets is recalling 13 German chocolate cakes mislabeled as Chocolate Iced Yellow Cake because they contain pecans not listed on the label.

    Product
    German chocolate cakes labeled as Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow, Net Wt. 1 lb 1 oz (482 g), UPC 0 41218 31168 6
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-3091-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3082-2017·2017-09-06

    Med Tec Rigid Arm Supports Recalled for Height Dimensional Variance

    Med Tec Inc is recalling 101 Rigid Arm Supports used in Posiboard-2 and Posirest systems due to a potential 17mm height difference.

    Product
    CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Po
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-3470-2017·2017-09-06

    Seven Sundays Muesli Recalled for Undeclared Almond Allergen

    Garden of Light Inc. is recalling Seven Sundays Vanilla Cherry Pecan Muesli because the product contains almonds but is labeled as containing only pecans.

    Product
    (a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz. pouch, UPC: 8-56088-00315-6 (b) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 2oz. cup UPC: 8-56088-00311-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3045-2017·2017-09-06

    Neusoft NeuViz 128 CT Scanner Software Defect Recall

    Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.

    Product
    Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstruc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3469-2017·2017-09-06

    Gold Medal Caramel Corn Mix Recalled for Undeclared Soy

    Gold Medal Products Co is recalling Corn Treats Concentrated Caramel Corn Mix because the label is missing an ingredient statement and does not declare soy.

    Product
    CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO.
    Category
    Food
    Distribution
    18 states
  • HighFDA (Devices)·Z-3080-2017·2017-09-06

    Vyaire Medical Recalls AirLife Reduced Heparin Arterial Blood Samplers

    Vyaire Medical is recalling specific lots of AirLife Reduced Heparin Arterial Blood Samplers because they contain incorrect sub-assemblies with larger needles, syringes, and heparin doses.

    Product
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which incl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3070-2017·2017-09-06

    Toshiba Ultimax Digital Fluoroscopic X-Ray System Recalled for Firmware Issue

    Toshiba is recalling 18 Ultimax Digital Fluoroscopic X-Ray Systems due to a firmware problem with the generator.

    Product
    Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-e
    Category
    Medical Device
    Distribution
    13 states

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