The Recall Desk

Archive

February 2017 recalls

436 recalls were announced in February 2017.

What the numbers show

Critical
36
Severe
125
High
176
Moderate
78
Low
21

Of the 436 recalls this month scored against our rubric, 8% are Critical, 29% are Severe.

301–400 of 436

  • ModerateFDA (Food)·F-1427-2017·2017-02-08

    Roland Manzanilla Olives Stuffed With Anchovies Recalled for Microorganisms

    Roland Foods is recalling Manzanilla Olives Stuffed With Anchovies because FDA sampling found non-pathogenic Gram Positive Rods.

    Product
    Roland MANZANILLA OLIVES STUFFED WITH ANCHOVIES, DR. WT. 3 OZ. (85g), UPC Code: 41224714021 and Case UPC Code: 10041224714028, Item # 71402, PRODUCT OF SPAIN
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2017·2017-02-08

    Immuno-Mycologics Recalls Cryptococcal Antigen Lateral Flow Assay Due to False Positives

    Immuno-Mycologics is recalling 630 units of the Cryptococcal Antigen Lateral Flow Assay because specific lots have lower specificity, leading to reported false positive results.

    Product
    Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2017·2017-02-08

    Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies

    Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.

    Product
    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0452-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0451-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling Flucanazole 150 mg tablets because they failed dissolution specifications and 18-month stability testing.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1117-2017·2017-02-08

    Ortho-Clinical VITROS Na+ Slides Recalled for Potential Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.

    Product
    VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2017·2017-02-08

    Siemens Mammomat Inspiration Mammography Systems Recalled for Software Error

    Siemens Medical Solutions USA is recalling 55 Mammomat Inspiration digital x-ray mammography systems due to a software error.

    Product
    Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1116-2017·2017-02-08

    Siemens Syngo.plaza PACS Software Recall for Issue Resolution

    Siemens Medical Solutions is recalling 62 Syngo.plaza PACS systems to install a software update that resolves several issues.

    Product
    Syngo.plaza, picture archiving and communications system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1115-2017·2017-02-08

    Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors

    Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.

    Product
    Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0454-2017·2017-02-08

    Ecolab Recalls Subpotent Chlorhexidine Gluconate Foam Solution

    Ecolab is recalling 427 bottles of Endure 400 Scrub-Stat foam solution because the product was found to be subpotent.

    Product
    Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in plastic (HDPE) bottles, Over-the-counter, Model Number: 61430436 (800 mL, 12 bottles/case) - United States; Model Number: 6000179 (800 mL, 12 bottles/case) - Canada, Ecolab, St. Paul, MN 5510
    Category
    Drug
    Distribution
    1 state
  • SevereUSDA FSIS·011-2017·2017-02-07

    Ukrop's Recalls Chili Flavored Soups Due To Undeclared Allergens

    Ukrop's Homestyle Foods is recalling approximately 45 pounds of beef and chicken chili flavored soups because they contain undeclared milk, wheat, and soy.

    Product
    Ukrop's Homestyle Foods — Ukrop’s Homestyle Foods Recalls Beef and Chicken Chili Flavored Soup Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighCPSC·17732·2017-02-07

    Sony Expands Recall of VAIO Laptop Battery Packs for Fire Hazards

    Sony is expanding a recall of Panasonic lithium-ion battery packs used in VAIO laptops due to overheating risks that can cause burns and fires.

    Product
    Panasonic battery packs used in Sony Electronics laptop computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V074000·2017-02-07

    Cruiser RV Recalls 2016-2017 Boss Trailers Due to Furnace Exhaust Defect

    Cruiser RV is recalling 2016-2017 Boss recreational trailers because a vertically-mounted furnace may have exhaust ports at the top, creating an unsafe operating condition.

    Product
    CRUISER RV — CRUISER RV BOSS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V072000·2017-02-03

    REV Recalls 2016-2017 Motorhomes Due to Fuel Leak Risk

    REV Recreation Group is recalling 391 Holiday Rambler and Fleetwood motorhomes because a spring shackle bolt may puncture fuel components, creating a fire hazard.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, FLEETWOOD VACATIONER XE, STORM, VACATIONER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V070000·2017-02-03

    Volkswagen Recalls 2017 Jetta Vehicles Due to Engine Seizure Risk

    Volkswagen is recalling 2017 Jetta vehicles with 1.4L engines because the engine block may be improperly cast, potentially causing the engine to seize and leading to a loss of vehicle control.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V071000·2017-02-03

    Midwest All-Poly 3000 Series Recalled for Brake Light Switch Defect

    Midwest Fire Equipment is recalling one 2017 All-Poly 3000 Series vehicle because the stop light switch may fail to illuminate brake lights, increasing crash risk.

    Product
    MIDWEST — MIDWEST ALL-POLY 3000 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·17V068000·2017-02-02

    Nissan Recalls 2002 Pathfinder and Infiniti QX4 for Air Bag Defect

    Nissan is recalling 2002 Pathfinder and Infiniti QX4 vehicles because the front passenger air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    INFINITI — INFINITI, NISSAN QX4, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V067000·2017-02-02

    BMW Recalls 2011-2012 Models for Rear Driveshaft CV Joint Defect

    BMW is recalling specific 2011-2012 models because the rear driveshaft CV joint may break, causing loss of propulsion and increasing crash risk.

    Product
    BMW — BMW 335I, Z4, 335D, 535I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17081·2017-02-02

    Disney Recalls Mickey Mouse Nightlights Due to Fire Hazard

    Walt Disney Parks and Resorts is recalling Happy Holidays! Mickey Mouse Nightlights because liquid can leak onto electrical outlets, posing a fire hazard.

    Product
    Happy Holidays! Mickey Mouse Nightlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V066000·2017-02-02

    Jayco Recalls 2017 Seismic Fifth-Wheel Trailers Due to Brake Wiring Defect

    Jayco is recalling 2017 Seismic and Seismic Wave fifth-wheel trailers because improper wiring may prevent the breakaway switch from functioning, increasing crash risk.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC WAVE, SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1361-2017·2017-02-01

    Earth Balance Vegan Mac and Cheese Recalled for Undeclared Milk

    Boulder Brands is recalling Earth Balance Vegan Mac and Cheese products due to undeclared milk, a major allergen.

    Product
    Earth Balance Vegan White Cheddar flavored Mac and Cheese, 6oz package, Cardboard box/carton, 12 packages per distributed case, Ambient storage.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1300-2017·2017-02-01

    Dutch-American Foods Recalls Truco Nacho Seasoning for Salmonella Risk

    Dutch-American Foods is recalling Truco Nacho seasoning products due to potential Salmonella contamination. The recall affects 6 bags distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Truco Nacho, NET Wt. 50 lbs (22.73kg)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1299-2017·2017-02-01

    Dutch-American Foods Recalls Natural Ranch Seasoning Due to Salmonella Risk

    Dutch-American Foods Inc is recalling Natural Ranch Seasoning due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Natural Ranch Seasoning, NET Wt. 50 lbs (22.73kg)
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1375-2017·2017-02-01

    Jem Cashew Masala Tahini Recalled Due to Confirmed Salmonella

    Jem Raw Chocolate LLC is recalling Cashew Masala Tahini in 16 oz, 6 oz, and 1.27 oz jars due to a confirmed positive test for Salmonella.

    Product
    Cashew Masala Tahini, Jem brand, 16 oz glass jar has UPC 8 61437 00037 3. Cashew Masala Tahini, Jem brand, 6 oz glass jar has UPC 8 61437 00034 2. Cashew Masala Tahini, Jem brand, 1.27 oz glass jar has UPC 8 61437 00033 5.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1301-2017·2017-02-01

    Dutch-American Foods Recalls Butter Popcorn Seasoning for Salmonella Risk

    Dutch-American Foods is recalling CCF Butter Popcorn Seasoning due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    CCF Butter Popcorn Seasoning, NET Wt. 1000 lbs, Gluten Free
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1064-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo multi-function x-ray systems after an injury incident involving inadvertent movement activation and delayed emergency stop response.

    Product
    Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0923-2017·2017-02-01

    Philips Allura Xper FD10 X-ray System Recalled for Loose Screws

    Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1346-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, Watermelon flavor (UPC 764779-4407566). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1351-2017·2017-02-01

    Metabolic Nutrition Pre-Workout Powder Recalled for Unapproved Ingredients

    IQ Formulations is recalling Metabolic Nutrition P.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, blue raspberry (UPC 764779-360122). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0922-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall for Loose Screws

    Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1337-2017·2017-02-01

    Victory General Foods Recalls Elder Paintsil's GA Kenkey for Insanitary Conditions

    Victory General Foods is recalling Elder Paintsil's GA Kenkey because it was manufactured under insanitary conditions and without following required food code processes.

    Product
    ELDER PAINTSIL'S GA KENKEY, NET WT. 1.20, UPC: 6 61799 58166 0, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1306-2017·2017-02-01

    Dutch-American Foods Recalls White Chocolate Mousse for Salmonella Risk

    Dutch-American Foods is recalling 2-Step White Chocolate Mousse due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    2-Step White Chocolate Mousse, NET WEIGHT: 1 BAG: 35 oz/ 1 kg
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1350-2017·2017-02-01

    IQ Formulations Recalls Pre-Workout Powder Containing Unapproved Ingredients

    IQ Formulations is recalling P.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, watermelon flavor (UPC 764779-360450). Brand: Metabolic Nutrition
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1099-2017·2017-02-01

    Roche Recalls Accu-Chek Connect App Due to Insulin Dosing Errors

    Roche Diabetes Care is recalling the Accu-Chek Connect app because software defects may cause incorrect insulin bolus recommendations, potentially leading to hypoglycemia.

    Product
    Accu-Chek Connect Diabetes Management App
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1065-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo DRF X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo DRF multi-function x-ray systems because a chain of faults led to an injury involving inadvertent movement activation.

    Product
    Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-0924-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

    Product
    Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0925-2017·2017-02-01

    Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.

    Product
    Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-1345-2017·2017-02-01

    SYNEDREX Weight Loss Solution Recalled for Unapproved Ingredients

    IQ Formulations is recalling SYNEDREX weight loss capsules because they contain Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    SYNEDREX, Powerful stimulant weight loss solution, 45 capsules (UPC 764779-224592). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1066-2017·2017-02-01

    Villa Radiology Systems Recalls Apollo EZ X-Ray Systems Due to Injury Risk

    Villa Radiology Systems LLC is recalling 66 Apollo EZ multi-function x-ray systems because a chain of faults caused an injury to a user.

    Product
    Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Food)·F-1357-2017·2017-02-01

    Berner Creamy Alfredo Pasta Sauce Recalled for Bacterial Contamination

    Berner Food & Beverage is recalling Creamy Alfredo Pasta Sauce contaminated with spoilage bacteria. Consumers should stop using the product.

    Product
    Creamy Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 41220845941, 70038626695 or 041498172855
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·17V065000·2017-02-01

    Highland Ridge Recalls 2016-2017 Open Range Fifth-Wheels for Axle Defect

    Highland Ridge RV is recalling 2016-2017 Open Range fifth-wheel vehicles because axle hangers may puncture the riser tube, causing axle misalignment and tire failure.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW OPEN RANGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1063-2017·2017-02-01

    Villa Radiology Juno DRF X-ray Systems Recalled for Injury Risk

    Villa Radiology Systems LLC is recalling Juno DRF x-ray systems after an injury occurred due to a chain of faults involving physical barriers and labeling.

    Product
    Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Food)·F-1362-2017·2017-02-01

    Earth Balance Vegan Mac and Cheese Recalled for Undeclared Milk

    Boulder Brands is recalling Earth Balance Vegan Mac and Cheese products because they contain undeclared milk, a major allergen.

    Product
    Earth Balance Vegan Cheddar flavored Mac and Cheese, 6oz package, Cardboard box/carton, 12 packages per distributed case, Ambient storage.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1302-2017·2017-02-01

    Dutch-American Foods Recalls Texas Sheet Cake Icing Base for Salmonella

    Dutch-American Foods is recalling Texas Sheet Cake Icing Base due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Texas Sheet Cake Icing Base, Kosher Dairy, Net Wt. 10 lbs, PB9663-10
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1303-2017·2017-02-01

    Dutch-American Foods Recalls Creamy Ranch Seasoning for Salmonella Risk

    Dutch-American Foods is recalling Creamy Ranch seasoning products due to potential Salmonella contamination. The recall affects 70 bags distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Creamy Ranch, Net Wt. 50 lbs (22.73 kg), Item Number 16131505
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1304-2017·2017-02-01

    Dutch-American Foods Recalls Smoky Bacon Blue Cheese for Salmonella Risk

    Dutch-American Foods is recalling Smoky Bacon Blue Cheese due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Smoky Bacon Blue Cheese, Net Wt. 50 lbs (22.73 kg), Item Number 16168803
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1336-2017·2017-02-01

    Victory General Foods Recalls Elder Paintsil's Fante Kenkey for Insanitary Conditions

    Victory General Foods is recalling Elder Paintsil's Fante Kenkey because it was manufactured under insanitary conditions and the firm did not follow the Food Code-mandated scheduled process.

    Product
    ELDER PAINTSIL'S FANTE KENKEY, NET WT. 1.20, UPC: 6 61799 58167 7, MANUFACTURED BY VICTORY GENERAL FOODS IN WORCESTER, MA 01603
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1305-2017·2017-02-01

    Dutch-American Foods Recalls White Chocolate Mousse for Salmonella Risk

    Dutch-American Foods is recalling 1-Step White Chocolate Mousse due to potential Salmonella contamination. Consumers in MD, MI, IL, and FL should stop using the product.

    Product
    1-Step White Chocolate Mousse, NET WEIGHT: 1 BAG: 35 oz/ 1 kg
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1379-2017·2017-02-01

    Pittsburgh Spice Recalls Buffalo Wing Sausage Due to Salmonella Risk

    Pittsburgh Spice and Seasoning Company is voluntarily recalling Buffalo Wing Sausage because a milk powder ingredient was recalled for possible salmonella contamination.

    Product
    Pittsburgh Spice Co; Buffalo Wing Sausage, 20.25 OZ for 25 #; 1235 Clairhaven St, Pittsburgh, PA 15205
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1074-2017·2017-02-01

    Medline Recalls Unna-Z Compression Wraps Due to Mold Contamination

    Medline Industries is recalling Unna-Z compression wraps due to contamination with common mold species. The recall affects units distributed in the US and several international countries.

    Product
    Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks.

    Product
    Maintenance Kit PH2, Cod. 6997274 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2017·2017-02-01

    Philips Recalls Velara Generators Due to Potential System Lockup

    Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.

    Product
    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1340-2017·2017-02-01

    Farm to Market Foods Recalls Green Bean Casserole for Undeclared Peanuts

    Farm to Market Foods is recalling Green Bean Casserole products in Texas due to undeclared peanuts. The recall affects specific lots and expiration dates.

    Product
    Farm to Market Foods Green Bean Casserole Code #1958 Net Wt. 6/1.95 lb. Trays with 6/.05 oz. Frenchs Fried Onions; Farm to Market Foods Green Bean Casserole Code #1971 Net Wt. 4/3.85 lb. Bags with 4/.15 oz. Frenchs Fried Onions UPC: 617037959029
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1083-2017·2017-02-01

    Atrium Medical Oasis Single Drain Recalled for Non-Sterile Packaging

    Atrium Medical is recalling Oasis Single Drains because the outer packaging is not sterile, posing a risk of infection.

    Product
    Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2017·2017-02-01

    Hitachi Oasis MRI C-Spine Coil Recalled Due to Overheating Balun

    Hitachi Medical Systems America Inc is recalling 180 Hitachi Oasis MRI System C-Spine Coils because the coil balun was found to be hot to the touch after an exam.

    Product
    Hitachi Oasis MRI System - C-Spine Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1341-2017·2017-02-01

    Farm to Market Foods Recalls Smoked Ham Dinner for Undeclared Peanuts

    Farm to Market Foods is recalling Smoked Ham Dinner #1977 Holiday products in Texas due to undeclared peanuts.

    Product
    Farm to Market Foods Smoked Ham Dinner #1977 Holiday Ingredients: Smoked Spiral Diced Ham, Mashed Potatoes, Orange Cranberry Relish, Broccoli Rice Casserole, Green Bean Casserole. Keep Refrigerated at 38 Deg F or Less UPC: 617037959081
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1106-2017·2017-02-01

    Philips Cisco 3850 Switch Recall Due to Monitoring Loss Risk

    Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.

    Product
    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1339-2017·2017-02-01

    Ambrosia Worcestershire Sauce Recalled for Undeclared Peanuts

    Schreiber Food International is recalling Ambrosia brand Worcestershire sauce because it may contain undeclared peanuts.

    Product
    Ambrosia Quality Foods Brand 4/1 gallon Worcestershire Sauce Net 128 Fl. Oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1354-2017·2017-02-01

    Tortillas Tita Recalls Corn Tortillas for Undeclared Wheat Allergen

    Tortillas Tita is voluntarily recalling specific lots of corn tortillas and tortilla enchilada produced between September 2016 and December 7, 2016, due to undeclared wheat.

    Product
    Corn Tortillas, 18 Count-16 Oz./453 g 16 units per case, 10 Count- 8 Oz./283 g 20 units per case, Mini- 12 Oz. 18 units per case, packed in plastic bags
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1090-2017·2017-02-01

    Roche Recalls Five cobas p 612 Pre-analytical Systems in Texas and Washington

    Roche Diagnostics is voluntarily recalling five cobas p 612 pre-analytical systems in Texas and Washington. The recall was initiated on December 27, 2016, and classified as Class II.

    Product
    cobas p 612 pre-analytical system; Pre-analytical sample handling that includes de-capping, Aliquotting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1077-2017·2017-02-01

    Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

    Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

    Product
    Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1310-2017·2017-02-01

    Dutch-American Foods Recalls Blueberry Donut Bases for Salmonella Risk

    Dutch-American Foods is recalling Blueberry Donut baking bases due to potential Salmonella contamination. The product was distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    Blueberry Donut , ST8300-50, NET WT. 50 LBS
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1343-2017·2017-02-01

    Stauffer's Animal Crackers Recalled for Potential Milk Contamination

    D. F. Stauffer Biscuit Co. is voluntarily recalling 32 oz. Original Animal Crackers because they may be packaged with cookies containing milk powder.

    Product
    FRONT: Stauffer's Animal Crackers Original; Net Wt. 32 OZ.; BACK: (best by date): 07SEP17; (bag lot numbers) LC120716 or LD120716; Stauffer Biscuit Co., York, PA 17403.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1098-2017·2017-02-01

    Softbank Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank decision support software due to a software error that may produce incorrect results.

    Product
    Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1307-2017·2017-02-01

    Dutch-American Foods Recalls French Vanilla Cappuccino for Salmonella Risk

    Dutch-American Foods is recalling French Vanilla Cappuccino products due to potential Salmonella contamination. The recall affects 123 bags distributed in Maryland, Michigan, Illinois, and Florida.

    Product
    French Vanilla Cappuccino, CP302140-12, NET WT. 12 LBS
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1062-2017·2017-02-01

    Philips Velara Generator Recall for System Lockup Risk

    Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.

    Product
    Velara Generator with an old Firmware version used with the Philips Integris BH5000
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1081-2017·2017-02-01

    Atrium Medical Recalls Pediatric Ocean Drains Due to Non-Sterile Packaging

    Atrium Medical is recalling Pediatric Chamber Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain Product Usage: To evacuate air and/or fluid from the chest cav
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1374-2017·2017-02-01

    Jem Cashew Curry Tahini Recalled Due to Confirmed Salmonella Presence

    Jem Raw Chocolate LLC is recalling Cashew Curry Tahini because a confirmed positive test for Salmonella was found. The product was distributed in California, Florida, and Ohio.

    Product
    Cashew Curry Tahini, Jem brand, 16 oz glass jar has UPC 8 61437 00036 6. Cashew Curry Tahini, Jem brand, 6 oz glass jar has UPC 8 61437 00035 9.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1342-2017·2017-02-01

    Farm to Market Foods Recalls Smoked Turkey Holiday Meals for Undeclared Peanuts

    Farm to Market Foods is recalling Smoked Turkey #1975 Holiday meals in Texas because they contain undeclared peanuts.

    Product
    Farm to Market Foods Smoked Turkey #1975 Holiday Ingredients: Smoked Turkey, Cornbread Dressing, Orange Cranberry Relish, Turkey Giblet Gravy, Green Bean Casserole, Mashed Potatoes. Keep Refrigerated at 38 Deg F or Less UPC: 617037959067
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1334-2017·2017-02-01

    Dear North Alaska Salmon Bites Recalled for Undeclared Soy

    Authentic Alaska is recalling Dear North Alaska Salmon Bites due to undeclared soy from tamari sauce. The product was distributed in California and Maryland.

    Product
    Alaska Salmon Bites (jerky), Spicy Fireweed Honey flavor, Dear North brand, Item # 2001, net wt. per pouch: 2 oz. UPC 8 15036 02001 0
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1097-2017·2017-02-01

    Softbank II Transfusion Software Recalled for Potential Incorrect Results

    Soft Computer Consultants is recalling Softbank II software due to a software error that may produce incorrect results in transfusion services.

    Product
    SCC Soft Computer Softbank II software Product Usage: Supports single and multi-site transfusion services in healthcare facilities. Used by healthcare personal to document, query, and view the integrated information regarding patients and products. Quality control testing, te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2017·2017-02-01

    Roche Tina-Quant CRP Latex Test System Recalled for Low Results

    Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

    Product
    Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical che
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1076-2017·2017-02-01

    INOmax DSIR Plus Delivery System Recalled for Inaccurate Valve Calibration

    INO Therapeutics is recalling 45 INOmax DSIR Plus delivery systems because an out-of-tolerance manometer may cause inaccurate valve calibration.

    Product
    Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1091-2017·2017-02-01

    Merge Hemo software recall due to potential connection issues

    Merge Healthcare is recalling Merge Hemo software versions 6.10 through 9.40.3 because the Hemo Monitor may fail to communicate with the Client PC during power-up.

    Product
    Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2017·2017-02-01

    Baxter Recalls Phoenix Dialysis Machine Preventive Maintenance Kits

    Baxter Healthcare is recalling Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone connectors that may cause fluid leaks during dialysis.

    Product
    Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or lo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2017·2017-02-01

    Atrium Medical Oasis Dual Chamber Drain Recall Due to Sterility Issue

    Atrium Medical is recalling Oasis dual chamber drains because the outer packaging is not sterile. The recall affects units with expiration dates prior to October 2019.

    Product
    Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1367-2017·2017-02-01

    Harris Teeter Recalls Everroast Chicken Caesar Wrap for Undeclared Fish

    Harris Teeter is recalling Everroast Chicken Caesar Wraps because they contain an undeclared fish allergen. The product was sold in eight states.

    Product
    Everroast Chicken Caesar Wrap, UPC: 72036-95828, in clear flexible plastic.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-1338-2017·2017-02-01

    Gonsalves Sugar Coated Almonds Recalled for Undeclared Wheat and Dyes

    The Henry Gonsalves Co. is recalling Gonsalves Sugar Coated Almonds because the product contains undeclared wheat and artificial dyes.

    Product
    Gonsalves Sugar Coated Almonds, Net Wt. 12 oz. Distributed by The Gonsalves Company, Smithfield, RI 02917 UPC number 20539-64550
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1335-2017·2017-02-01

    Dear North Alaska Salmon Bites Recalled for Undeclared Soy

    Authentic Alaska is recalling Dear North Alaska Salmon Bites due to undeclared soy from tamari sauce. The product was distributed in California and Maryland.

    Product
    Alaska Salmon Bites (jerky), Rhubarb & Raspberries flavor, Dear North brand, Item # 2002, net wt. per pouch: 2 oz. UPC 8 15036 02002 7.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0444-2017·2017-02-01

    Mylan Recalls Temozolomide Capsules Due to Broken Capsules and Loose Powder

    Mylan LLC is recalling 588 bottles of Temozolomide Capsules, 250 mg, due to customer complaints of broken capsules and loose powder in the bottles.

    Product
    Temozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA, NDC 0378-5265-98.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1104-2017·2017-02-01

    Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance

    Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.

    Product
    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provide
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1079-2017·2017-02-01

    Atrium Medical Ocean Drains Recalled Due to Non-Sterile Outer Packaging

    Atrium Medical is recalling Ocean Drains because the outer packaging is not sterile. The recall covers units with expiration dates prior to October 2019.

    Product
    Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Ocean single drain, in-line connector and suction control stopcock, Pedi connector in bag on back of the drain 2002-050 Ocean single drain with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1071-2017·2017-02-01

    Binding Site IgG4 Reagent Kits Recalled for Inaccurate Results

    The Binding Site Group is recalling Human IgG4 Subclass Liquid Reagent Kits because they may yield spuriously low results for samples with extremely high IgG4 levels.

    Product
    Human lgG4 Subclass Liquid Reagent Kits for use on the Siemens BN"II Analyser Product Code: NK009.T This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ai
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1352-2017·2017-02-01

    Metabolic Nutrition Pre-Workout Powder Recalled for Unapproved Ingredients

    IQ Formulations is recalling Metabolic Nutrition P.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, fruit punch (UPC 764779-360238). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1349-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains Picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, green apple (UPC 764779-430740). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1360-2017·2017-02-01

    Berner Food Recalls Our Family Alfredo Pasta Sauce Due to Bacteria

    Berner Food & Beverage, LLC is recalling Our Family Alfredo Pasta Sauce contaminated with spoilage bacteria. Consumers should discard the product.

    Product
    Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1353-2017·2017-02-01

    IQ Formulations Recalls Pre-Workout Powder Containing Unapproved Ingredients

    IQ Formulations is recalling P.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    P.S.P., Pre-Workout, Physique Stimulating Pre-workout, Powder, 360 g, green apple (UPC 764779-360344). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1348-2017·2017-02-01

    IQ Formulations Recalls E.S.P. Pre-Workout Powder for Unapproved Ingredients

    IQ Formulations is recalling E.S.P. Pre-Workout powder because it contains picamilon and/or methylpentane citrate, which are not recognized as dietary ingredients.

    Product
    E.S.P. Pre-Workout, Energy Stimulant Pre-workout, Powder, 300 g, fruit punch flavor (UPC 764779-420734), fruit punch (UPC 764779-430740). Brand: Metabolic Nutrition.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1093-2017·2017-02-01

    Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation

    Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.

    Product
    Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Drugs)·D-0447-2017·2017-02-01

    Cambrex Recalls Mesalamine API Due to Stainless Steel Particulate Matter

    Cambrex Charles City Inc is recalling Mesalamine API due to the presence of stainless steel particulate matter detected in the finished product.

    Product
    Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboard drums. Net weight 40 kg
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1057-2017·2017-02-01

    On-X Chord-X Chordal Sizer Recalled for Manufacturing Defects

    On-X Life Technologies is recalling 45 units of the Chord-X Chordal Sizer due to manufacturing defects including burrs, particulate, hair, and assembly errors.

    Product
    Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repa
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1078-2017·2017-02-01

    Sekisui Diagnostics Ammonia L3K Assay Recalled for Performance Issues

    Sekisui Diagnostics is recalling specific lots of the Ammonia L3K Assay because atypical optical density decreases may impact performance at the high end of the linear range.

    Product
    Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
    Category
    Medical Device
    Distribution
    12 states

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