The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
188
High
305
Moderate
102
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

Which agencies issued them

101–200 of 633

  • HighFDA (Devices)·Z-2774-2018·2018-09-26

    Degania Silicone Foley Catheters Recalled for Defective Temperature Sensors

    Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3013-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers

    Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.

    Product
    CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3192-2018·2018-09-26

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error

    Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.

    Product
    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2778-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2777-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 2,784 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3190-2018·2018-09-26

    Siemens ARTIS Pheno X-Ray System Recalled for Temperature Control Defect

    Siemens is recalling 429 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool below its designed operating range.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3198-2018·2018-09-26

    Biocare Medical Recalls URO-3 Triple Stain Kits Due to Component Mislabeling

    Biocare Medical is recalling 11 URO-3 Triple Stain kits because two components were mislabeled, causing incorrect staining patterns in laboratory tests.

    Product
    URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3199-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Inclusion

    Arrow International is recalling specific PICC kits because they may contain the wrong catheter type, potentially delaying patient treatment.

    Product
    4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-1197-2018·2018-09-26

    Beaumont Bio-Med Recalls Allergy & Hay Fever Relief Homeopathic Formula

    Beaumont Bio-Med is recalling 124 bottles of Allergy & Hay Fever Relief Homeopathic Formula due to CGMP deviations that could result in possible microbial contamination.

    Product
    Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1196-2018·2018-09-26

    Beaumont Bio-Med Recalls Muscle & Joint Pain Relief Spray for CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 109 bottles of Muscle & Joint Pain Relief Homeopathic Formula due to CGMP deviations that could result in possible microbial contamination.

    Product
    Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2767-2018·2018-09-26

    Foley Catheter with Temperature Sensor Recalled for Defective Sensors

    Degania Silicone is recalling 12,532 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1198-2018·2018-09-26

    Beaumont Bio-Med Recalls Colds & Flu Response Homeopathic Formula

    Beaumont Bio-Med is recalling Colds & Flu Response Homeopathic Formula due to potential microbial contamination from manufacturing deviations.

    Product
    Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1965-2018·2018-09-26

    Blommer Natural Cocoa Butter Bulk Tanker Recalled for Process Deviation

    Blommer Chocolate Co. is recalling 95,040 lbs of Natural Cocoa Butter Bulk Tanker due to a critical process deviation. The product was distributed in Illinois and New Jersey.

    Product
    Blommer Natural Cocoa Butter Bulk Tanker
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3001-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.

    Product
    iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1199-2018·2018-09-26

    Beaumont Bio-Med Recalls Arthritis Pain Relief Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling 140 bottles of Arthritis Pain Relief Homeopathic Formula due to manufacturing conditions that could result in microbial contamination.

    Product
    Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3185-2018·2018-09-26

    Polymedco PATHFAST Myoglobin II Cartridges Recalled for Leakage

    Polymedco is recalling 272 PATHFAST Myoglobin II reagent cartridges due to a pinhole defect that may cause measurement bias.

    Product
    PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1195-2018·2018-09-26

    Beaumont Bio-Med Recalls Diarrhea Response Homeopathic Formula Due to CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 160 bottles of Diarrhea Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3189-2018·2018-09-26

    Siemens Artis Q X-Ray Systems Recalled for Temperature Control Defect

    Siemens is recalling 429 Artis Q Interventional Fluoroscopic X-Ray Systems because a temperature control defect may cause the detector to cool down outside its designed working range.

    Product
    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1192-2018·2018-09-26

    Beaumont Bio-Med Recalls Skin Irritation Homeopathic Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling Skin Irritation & Itch Response Homeopathic Formula due to manufacturing deviations that could result in possible microbial contamination.

    Product
    Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3179-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P640 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P640 cards because some lots contain insufficient gentamicin, potentially affecting high-level resistance test results.

    Product
    VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3197-2018·2018-09-26

    Arrow Bipolar Electrode Catheter Recalled for Incorrect Expiration Date Labeling

    Arrow International Inc. is recalling 7 units of a specific bipolar electrode catheter lot because they are labeled with an incorrect expiration date.

    Product
    ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3182-2018·2018-09-26

    Mako Surgical Recalls RIO Standard System Components for Connection Errors

    Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.

    Product
    Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3008-2018·2018-09-26

    Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.

    Product
    VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1194-2018·2018-09-26

    Beaumont Bio-Med Recalls Sore Throat Homeopathic Spray Due to CGMP Deviations

    Beaumont Bio-Med is recalling Sore Throat & Laryngitis Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3176-2018·2018-09-26

    Zimmer Biomet Recalls Commingled Gentle Thread PLGA Interference Screws

    Zimmer Biomet is recalling 52 Gentle Thread PLGA Round Head Interference Screws because they were commingled with a different screw size.

    Product
    Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3187-2018·2018-09-26

    Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues

    Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.

    Product
    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3200-2018·2018-09-26

    Arrow International Recalls PICC Kits Due to Incorrect Catheter Type

    Arrow International is recalling 5.5 Fr x 5.5 Fr x 40 cm double-lumen PICC Kits because they may contain the wrong catheter type, potentially delaying treatment.

    Product
    5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Food)·F-1970-2018·2018-09-26

    Stewart's Ice Cream Recalled for Incorrect Lid Packaging

    Stewart's Shops Corp. is recalling 5,455 pints of Caramel Cone Crunch ice cream because some containers were packaged with the wrong lid.

    Product
    Stewart's Ice Cream Caramel Cone Crunch Carton, 1 pint, keep frozen, UPC: 082086444718
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-3193-2018·2018-09-26

    Ortho-Clinical VITROS Chemistry CREA Slides Recalled for Measurement Accuracy Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CREA Slides because they failed to meet accuracy standards for low-end creatinine measurements in serum and urine.

    Product
    VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1214-2018·2018-09-26

    Lupin Recalls Morphine Sulfate Extended-Release Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because testing found an impurity exceeding safety limits.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1212-2018·2018-09-26

    InvaGen Recalls Bupropion Hydrochloride Tablets Due to Impurity Levels

    InvaGen Pharmaceuticals is recalling specific lots of Bupropion Hydrochloride ER tablets because older batches failed impurity specifications.

    Product
    BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3196-2018·2018-09-26

    Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits

    Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.

    Product
    Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1205-2018·2018-09-26

    Jubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure

    Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets due to failed stability testing. The product was distributed throughout the United States.

    Product
    MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-3184-2018·2018-09-26

    Ortho-Clinical VITROS Chloride Slides Recalled for Analytical Performance Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Cl- Slides because they failed to meet performance standards for urine samples.

    Product
    VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V668000·2018-09-25

    Volvo Recalls VNL Trucks Due to Fuel Line Burst Risk

    Volvo is recalling 2016-2019 VNL trucks with Cummins ISX15 engines because a restricted fuel pump cooling circuit screen may cause the fuel line to burst.

    Product
    VOLVO — VOLVO VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18230·2018-09-25

    Traeger Recalls Scout and Ranger Grills Due to Fire Hazard

    Traeger Grills is recalling Scout and Ranger portable wood pellet grills because grease can leak from the drip tray, posing a fire hazard.

    Product
    Scout and Ranger portable wood pellet grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V667000·2018-09-25

    Suzuki Recalls 2006 Grand Vitara for Power Steering Belt Tensioner Defect

    Suzuki is recalling 2006 Grand Vitara vehicles because a plastic component in the power steering system can deteriorate, potentially causing a loss of steering assist and increasing crash risk.

    Product
    SUZUKI — SUZUKI GRAND VITARA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V669000·2018-09-25

    Maintainer Service Mechanic Bodies Recalled for Driveshaft Interference Risk

    Maintainer is recalling 2017-2018 Service Mechanic Bodies mounted on Ford F-Series Super Duty trucks because a hydraulic pump may interfere with the front axle driveshaft, potentially causing separation and increasing crash risk.

    Product
    MAINTAINER — MAINTAINER SERVICE/MECHANICBODY FORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V666000·2018-09-25

    Kia Recalls 2017-2018 Niro Hybrids for Fire Risk

    Kia is recalling 2017-2018 Niro hybrid vehicles because a faulty relay may overheat the rear seat, increasing the risk of a fire.

    Product
    KIA — KIA NIRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18229·2018-09-25

    Desert Harvest Recalls Skin Repair Cream for Child-Resistant Closure Failure

    Desert Harvest is recalling Reléveum Skin Repair Cream because the bottles do not meet child-resistant closure requirements, posing a poisoning risk to young children.

    Product
    Desert Harvest Reléveum Skin Repair Cream
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18E093000·2018-09-25

    Ioxus uStart Energy Storage Modules Recalled for Fire Risk

    Ioxus is recalling uStart energy storage modules because a seal defect may allow moisture entry, potentially causing electrical shorts and fire.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18231·2018-09-25

    Provata Recalls Activity Trackers Due to Burn Hazard

    Provata Health is recalling about 30,000 promotional activity trackers because they can overheat and cause burns. Consumers should stop using the devices and contact the company for a free replacement.

    Product
    Provata activity trackers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V658000·2018-09-24

    Grand Design Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Grand Design is recalling 2019 Reflection, Imagine, and Transcend travel trailers because missing inner axle bearings may cause overheating and fire.

    Product
    GRAND DESIGN — GRAND DESIGN TRANSCEND, REFLECTION, IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V660000·2018-09-24

    Fontaine Recalls 2019 Infinity Trailers for Rear Impact Guard Defect

    Fontaine Trailer Company is recalling 2019 Infinity trailers because incorrect rear impact guards may not prevent vehicles from sliding underneath during a crash.

    Product
    FONTAINE — FONTAINE INFINITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V659000·2018-09-24

    Winnebago Recalls 2019 Horizon RVs Due to Door Latch Defect

    Winnebago is recalling 2019 Horizon vehicles because improperly adjusted door latch rods may allow the entry door to open while moving, increasing the risk of injury or a crash.

    Product
    WINNEBAGO — WINNEBAGO HORIZON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V655000·2018-09-21

    GM Recalls 2016-2018 Chevrolet Express and GMC Savana for Fire Risk

    General Motors is recalling 2016-2018 Chevrolet Express and GMC Savana vans due to a potential electrical short in the rear climate control module that could cause a headliner fire.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V634000·2018-09-21

    Heartland Recalls 2019 Travel Trailers Due to Axle Bearing Defect

    Heartland is recalling 2019 travel trailers because missing inner bearing races may cause hub overheating or separation, increasing crash risk.

    Product
    HEARTLAND — HEARTLAND NORTH TRAIL, WILDERNESS, TRAIL RUNNER, MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V657000·2018-09-21

    PACCAR Recalls Kenworth and Peterbilt Trucks Due to Fuel Line Burst Risk

    PACCAR is recalling 2017-2019 Kenworth and Peterbilt trucks equipped with Cummins ISX15 or X15 diesel engines because a restricted fuel pump cooling circuit screen may cause the fuel line to burst.

    Product
    KENWORTH — KENWORTH, PETERBILT T880, T680, W900, T800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18226·2018-09-21

    Woodcraft Recalls Motorcycle Handlebar Adapters Due to Crash Hazard

    Woodcraft is recalling clip-on adapter plates for Yamaha and Ducati motorcycles because they can crack and fail, posing a crash hazard. No injuries have been reported.

    Product
    Woodcraft clip-on adapters for motorcycle handlebars
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V653000·2018-09-21

    Dennis Eagle Elite Garbage Trucks Recalled for Ignition Barrel Defect

    Dennis Eagle is recalling 2017-2018 Elite garbage trucks because improperly secured ignition barrels may detach, causing the vehicle to stall and increasing crash risk.

    Product
    DENNIS EAGLE — DENNIS EAGLE ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·083-2018·2018-09-21

    Junior's Smokehouse Recalls Beef Jerky Due to Metal Contamination

    Junior's Smokehouse is recalling teriyaki beef jerky produced in August 2018 due to possible hard metal contamination. No illnesses have been reported.

    Product
    Junior's Smokehouse Processing Plant — Junior's Smokehouse Processing Plant Recalls Beef Jerky Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18E092000·2018-09-20

    BMW Recalls TurboCord Portable Chargers Due to Fire and Shock Risk

    BMW is recalling TurboCord Portable Chargers because failing capacitors may cause electrical shock or fire, increasing the risk of injury or death.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V652000·2018-09-20

    BMW Recalls 2018-2019 Models for TurboCord Charger Fire Risk

    BMW is recalling specific 2018-2019 electric and hybrid models because capacitors in the TurboCord Portable Chargers may fail, posing a shock or fire hazard.

    Product
    BMW — BMW 740LE, 530E, X5, I3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E091000·2018-09-20

    Toyota Recalls Scion xB and tC Vehicles with TRD Brake Kits

    Toyota is recalling 2008-2015 Scion xB and 2011-2016 Scion tC vehicles equipped with specific TRD brake kits because the hoses may fail, increasing crash risk.

    Product
    SCION — SCION XB, TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18227·2018-09-20

    Kaz Recalls Stinger Insect Zappers Due to Internal Shock Hazard

    Kaz is recalling about 72,000 Stinger insect zappers because the internal kill grid can detach, posing a shock hazard. No injuries have been reported.

    Product
    Stinger Insect Zappers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18225·2018-09-20

    Weeplay Kids Recalls Children's Coveralls Due to Choking Hazard

    Weeplay Kids is recalling ED by Ellen DeGeneres children's coveralls because the bunny applique can detach, posing a choking hazard to young children.

    Product
    ED by Ellen DeGeneres coveralls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18767·2018-09-20

    Titan Recalls Weight Lifting Safety Straps Due to Injury Hazard

    Titan is recalling weight lifting safety straps because stitching can come loose, causing heavy weights to fall. No injuries have been reported.

    Product
    Titan safety straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·082-2018·2018-09-20

    Zweigle's Olive Loaf Pork Products Recalled for Excess Sodium Nitrite

    Zweigle's Inc. is recalling approximately 6,082 pounds of ready-to-eat olive loaf pork products due to sodium nitrite levels exceeding regulatory limits.

    Product
    Zweigle's Inc. — Zweigle's Inc. Recalls Olive Loaf Pork Products due to Sodium Nitrite Levels in Excess of Regulatory Limit
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1203-2018·2018-09-19

    FDA Recalls Respitrol Homeopathic Medicine Due to Microbial Contamination

    The FDA is recalling Respitrol Homeopathic OTC Medicine because it is contaminated with microorganisms, including Staphylococcus saprophyticus and Burkholderia cepacia.

    Product
    Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1201-2018·2018-09-19

    FDA Recalls Neuroveen Homeopathic OTC Medicine for Microbial Contamination

    The FDA is recalling Neuroveen Homeopathic OTC Medicine due to microbial contamination with Staphylococcus saprophyticus and Burkholderia cepacia.

    Product
    Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0004-2019·2018-09-19

    Fuzhou Fish Balls Recalled for Undeclared Allergens

    H & C Food Inc. is recalling Fuzhou Fish Balls because they contain undeclared egg, crustacean, and pork.

    Product
    Fuzhou Fish Balls, packaged in a blue and white package bag, in two sizes: Net WT: 14 OZ (400g), UPC: 6 953640 05000 and Net WT:4.5 lbs. (2043g), UPC: 6 953640 050017. Keep Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1206-2018·2018-09-19

    Accord Recalls Hydrochlorothiazide Tablets Due to Product Mix-Up

    Accord Healthcare is recalling Hydrochlorothiazide 12.5 mg tablets because a customer complaint found Spironolactone 25 mg tablets in the bottles.

    Product
    HYDROCHLOROTHIAZIDE — HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1975-2018·2018-09-19

    Air Stream Corp. Recalls Salad Mix Due to Listeria Contamination

    Air Stream Corp. is recalling specific lots of salad mix because the product may be contaminated with Listeria monocytogenes.

    Product
    Salad Mix (Endive, Chicory, Romaine, Escarole, and Radicchio)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-1980-2018·2018-09-19

    Aztlan Mole Poblano Recalled for Undeclared Milk, Wheat, and Soy Allergens

    Hidroponicos Brownia is recalling Aztlan Mole Poblano because milk, wheat, and soy were not declared as ingredients or in the allergen statement.

    Product
    Aztlan Mole Poblano; 10 kg plastic buckets (22 lbs); Ingredients: sugar, Ancho pepper, peanut, soybean oil, pasilla pepper, guajillo pepper, sesame seed, cookie, cocoa, corn flour, idozided salt, condiments and spices. Sodium benzoate as a preservative. Distributed by/dis
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·081-2018·2018-09-19

    Cargill Recalls Ground Beef Due to E. coli O26 Contamination

    Cargill Meat Solutions is recalling approximately 132,606 pounds of ground beef products that may be contaminated with E. coli O26. The recall follows an investigation linking the bacteria to 17 illnesses and one death.

    Product
    Cargill Meat Solutions — Cargill Meat Solutions Recalls Ground Beef Products due to Possible E. coli O26 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1202-2018·2018-09-19

    HelloLife Recalls Thyroveev Homeopathic Medicine Due to Microbial Contamination

    HelloLife is recalling 370 bottles of Thyroveev homeopathic medicine due to microbial contamination. The product was distributed nationwide and internationally.

    Product
    Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1974-2018·2018-09-19

    Air Stream Corp. Recalls Salad Mix Due to Listeria Contamination Risk

    Air Stream Corp. is recalling specific lots of salad mix because the product may be contaminated with Listeria monocytogenes.

    Product
    Salad Mix (Green Kale, Green Cabbage, Broccoli Stems, Chicory, and Brussel Sprouts)
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Drugs)·D-1200-2018·2018-09-19

    FDA Recalls Compulsin Homeopathic OTC Medicine Due to Microbial Contamination

    The FDA is recalling Compulsin Homeopathic OTC Medicine because it is contaminated with microorganisms, including Staphylococcus saprophyticus and Burkholderia cepacia.

    Product
    Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0003-2019·2018-09-19

    H & C Food Inc. Recalls Fish Balls for Undeclared Allergens

    H & C Food Inc. is recalling 14-ounce bags of fish balls because they contain undeclared egg and crustacean allergens.

    Product
    Fish Balls, packaged in a red and white plastic bag with gold font, NET WT: 14OZ (400g), UPC: 6 953006 4 50093. Keep Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-3086-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 420 mm, Item Number: 814409420
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3142-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 320 mm, Item Number: 814515320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3170-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 400 mm, Item Number: 814613400
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3166-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3095-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 420 mm, Item Number: 814411420
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3106-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3144-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3068-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 280 mm, Item Number: 814313280
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3136-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 340 mm, Item Number: 814513340
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3127-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 380 mm, Item Number: 814511380
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Drugs)·D-1189-2018·2018-09-19

    SCA Pharmaceuticals Recalls Furosemide Injection Bags Due to Precipitate

    SCA Pharmaceuticals is recalling 1,384 bags of Furosemide injection due to visible precipitate. The product was distributed to three hospitals in DC, VA, and CT.

    Product
    Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-3134-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 280 mm, Item Number: 814513280
    Category
    Medical Device
    Distribution
    42 states
  • SevereNHTSA·18V643000·2018-09-19

    Livin' Lite CampLite Travel Trailers Recalled for Drawbar Crack Risk

    Livin' Lite is recalling 2017-2019 CampLite travel trailers because the drawbar may crack, causing the trailer to separate from the tow vehicle.

    Product
    LIVIN' LITE — LIVIN' LITE CAMPLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3058-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-3168-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 360 mm, Item Number: 814613360
    Category
    Medical Device
    Distribution
    42 states
  • SevereNHTSA·18V646000·2018-09-19

    Freightliner Recalls 2018-2019 Models Due to Steering Shaft Defect

    Daimler Trucks North America is recalling 2018-2019 Freightliner 108SD, 114SD, and Business Class M2 vehicles because an incorrectly installed steering shaft may disconnect the steering wheel from the front wheels.

    Product
    FREIGHTLINER — FREIGHTLINER 108SD, 114SD, BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V641000·2018-09-19

    Daimler Trucks Recalls 2019 Freightliner and Western Star Trucks for Tire Defect

    Daimler Trucks is recalling 2019 Freightliner and Western Star trucks because exposed tire sidewall steel cords may cause rapid air loss, increasing crash risk.

    Product
    WESTERN STAR — WESTERN STAR, FREIGHTLINER 4900, 4700, BUSINESS CLASS M2, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3099-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 280 mm, Item Number: 814413280
    Category
    Medical Device
    Distribution
    42 states
  • SevereNHTSA·18V647000·2018-09-19

    Spartan Metrostar Emergency Vehicles Recalled for Wheel Stud Defect

    Spartan Motors is recalling 2018-2019 Metrostar emergency vehicles because improperly heat-treated wheel studs may fail, potentially causing the wheel to detach.

    Product
    SPARTAN — SPARTAN METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3098-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling 5,947 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260
    Category
    Medical Device
    Distribution
    42 states

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