The Recall Desk

Archive

October 2016 recalls

1,035 recalls were announced in October 2016.

What the numbers show

Critical
136
Severe
242
High
453
Moderate
173
Low
31

Of the 1,035 recalls this month scored against our rubric, 13% are Critical, 23% are Severe.

901–1000 of 1035

  • LowFDA (Drugs)·D-0006-2017·2016-10-12

    Shire Recalls Vyvanse Capsules Due to Presence of Foreign Tablets

    Shire is recalling 7,680 bottles of Vyvanse 30 mg capsules because foreign tablets or capsules were found in the product.

    Product
    VYVANSE — VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2918-2016·2016-10-12

    Arthrex Suture Washer Recalled Due to Incorrect Assembly

    Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.

    Product
    Arthrex Suture Washer
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Food)·F-2643-2016·2016-10-12

    Coca-Cola Recalls Dr Pepper Cans With Defective Opening Mechanism

    The Coca-Cola Company is recalling specific lots of Dr Pepper and Diet Dr Pepper cans where the opening tab may pop upward instead of downward.

    Product
    Diet Dr Pepper, 12 oz. can/24 pack, UPC 078000083132; Diet Dr Pepper, 12 oz. can/6 pack, UPC N/A; Diet Dr Pepper, 12 oz. can/20 pack, UPC 078000083095; Dr Pepper, 12 oz. can/6 pack, UPC N/A; Dr Pepper , 12 oz. can/ 20 pack, UPC 078000082098; Dr Pepper 12 oz. can/ 12 pack, UPC 078
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-2913-2016·2016-10-12

    Siemens RAPIDPoint 405 Cartridges Recalled for Chloride Calibration Error

    Siemens Healthcare Diagnostics is recalling RAPIDPoint 405 Measurement Cartridges due to an error in the value assignment for Chloride calibrators.

    Product
    Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0001-2017·2016-10-12

    Varithena Administration Packs Recalled Due to Incorrect Syringe Type

    Biocompatibles is recalling Varithena administration packs because they contain the incorrect type of syringe. The recall covers 3,254 packs distributed nationwide.

    Product
    VARITHENA — VARITHENA (POLIDOCANOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0001-2017·2016-10-12

    Terumo CDI H/S Cuvette Recall Due to Connection Error

    Terumo is recalling CDI H/S Cuvettes because they may fail to connect to the probe, causing the monitor to display an error and preventing blood parameter display.

    Product
    CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V726000·2016-10-11

    Hyundai Recalls Sonata Models Due to Sunroof Detachment Risk

    Hyundai is recalling 2015-2016 Sonata and Sonata Hybrid vehicles because the panoramic sunroof panel may detach while driving, creating a road hazard.

    Product
    HYUNDAI — HYUNDAI SONATA, SONATA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V725000·2016-10-11

    Honda Recalls 2016 Civic Vehicles Due to Electric Parking Brake Defect

    Honda is recalling 2016 Civic vehicles because the electric parking brake may fail to engage immediately after the ignition is turned off, increasing the risk of the vehicle rolling away.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V724000·2016-10-11

    Nissan Recalls 2017 Versa Vehicles for Side Air Bag Defect

    Nissan is recalling 2017 Versa vehicles because a seam in the side curtain air bags may tear during deployment, increasing the risk of injury in a crash.

    Product
    NISSAN — NISSAN VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·093-2016·2016-10-09

    Kraft Heinz Recalls Lunchables Ham and American Cracker Stackers for Undeclared Allergens

    Kraft Heinz is recalling approximately 959 pounds of Lunchables Ham and American Cracker Stackers because the product contains undeclared wheat and soy allergens.

    Product
    Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers Product Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V718000·2016-10-07

    REV Recalls 2016-2017 Ambulances Due to Defective Attendant Seat Tracks

    REV Ambulance Group is recalling 39 ambulances from 2016-2017 because defective seat tracks may allow attendant seats to move rapidly during a crash, increasing injury risk.

    Product
    FRONTLINE — FRONTLINE, WHEELED COACH, MCCOY MILLER TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V723000·2016-10-07

    Autocar Recalls Xspotter and Xpert Vehicles for Steering Linkage Defect

    Autocar is recalling 1,132 model year 2015-2017 Xspotter and Xpert vehicles because improperly tightened steering linkage nuts could cause loss of steering.

    Product
    AUTOCAR — AUTOCAR XSPOTTER, XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V722000·2016-10-07

    Hyundai Recalls Genesis Coupe Due to Air Bag Sensor Connector Issue

    Hyundai is recalling 2010-2016 Genesis Coupe vehicles because the front passenger air bag sensor connector may dislodge, potentially causing incorrect air bag deployment in a crash.

    Product
    HYUNDAI — HYUNDAI GENESIS COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V721000·2016-10-07

    Newmar Recalls 2015 Dutch Star Motorhomes Due to Brake Signal Defect

    Newmar is recalling 2015 Dutch Star motorhomes because the brake signal to towed devices may not deactivate, causing dragging brakes, overheating, fire, or crashes.

    Product
    NEWMAR — NEWMAR DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V719000·2016-10-07

    Winnebago Recalls 2016-2017 Travel Trailers Due to Incorrect Weight Labels

    Winnebago is recalling 2016-2017 travel trailers because weight labels list fresh water capacity in gallons instead of pounds, which may cause overloading.

    Product
    WINNEBAGO — WINNEBAGO WINNIE DROP, SPYDER, MINNIE PLUS, MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·091-2016 EXP·2016-10-07

    Silver Springs Farms Recalls Beef Products Due To Possible E. Coli O157:H7

    Silver Springs Farms is recalling ground beef and sandwich steak products that may be adulterated with E. coli O157:H7.

    Product
    Silver Springs Farms, Inc. Recalls Beef Products Due To Possible E. Coli O157:H7 Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V713000·2016-10-06

    Jayco Recalls 2017 Seismic Travel Trailers Due to Fire Risk

    Jayco is recalling 137 model year 2017 Seismic travel trailers because an incorrect fuse may fail to protect the circuit, increasing the risk of an electrical fire.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V714000·2016-10-06

    Mack Recalls 2017 Pinnacle Trucks Due to Tire Tread Separation Risk

    Mack Trucks is recalling 57 model year 2017 Pinnacle CHU and CXU trucks because improperly cured tires may cause partial tread separation, increasing crash risk.

    Product
    MACK — MACK PINNACLE (CHU), PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·17007·2016-10-06

    Summer Infant Recalls Bath Tubs Due to Sling Detachment Risk

    Summer Infant is recalling Lil' Luxuries infant bath tubs because the fabric slings can detach, posing risks of impact injury and drowning.

    Product
    Lil' Luxuries infant bath tubs with fabric slings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V716000·2016-10-06

    Subaru Recalls 2017 Legacy and Outback for Knee Guard Defect

    Subaru is recalling 2017 Legacy and Outback vehicles because the knee guard bracket may not be properly attached, increasing injury risk in crashes.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17703·2016-10-06

    Wildhorn Outfitters Recalls Camping Hammocks Due to Fall Hazard

    Wildhorn Outfitters is recalling about 9,700 Outpost camping hammocks and suspension kits because cinch buckles can fail, posing a fall hazard.

    Product
    Wildhorn Outfitters Outpost camping hammocks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17005·2016-10-06

    Aqua Lung Recalls Powerline Inflators Due to Injury and Drowning Hazards

    Aqua Lung is recalling about 53,000 Powerline inflators because the inflation button can remain depressed, causing uncontrolled ascent and posing injury and drowning hazards.

    Product
    Aqua Lung Powerline inflators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16T017000·2016-10-06

    GITI Recalls Tires With Sidewall Cracks That May Cause Air Loss

    GITI Tire is recalling specific Primewell, GT Radial, and Dextero tires that may develop sidewall cracks, potentially leading to air loss and tire failure.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V715000·2016-10-06

    Newmar Recalls 2017 Motorhomes Due to Power Steering Pump Defect

    Newmar is recalling 2017 King Aire, Essex, London Aire, and Mountain Aire motorhomes because a power steering pump defect may cause intermittent loss of steering assist.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, KING AIRE, ESSEX, LONDON AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2469-2016·2016-10-05

    Grassfields Cheese Recalls Organic Raw Milk Polkton Corners Cheese

    Grassfields Cheese, LLC is recalling organic raw milk Polkton Corners cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Polkton Corners 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2465-2016·2016-10-05

    Grassfields Organic Raw Milk Edam Cheese Recalled for E. coli Risk

    Grassfields Cheese is recalling organic raw milk Edam cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Edam 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2462-2016·2016-10-05

    Grassfields Onion and Garlic Raw Milk Cheese Recalled for E. coli

    Grassfields Cheese is recalling Onion and Garlic raw milk cheese due to potential Shiga toxin-producing E. coli contamination.

    Product
    Onion n Garlic 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk c
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2154-2016·2016-10-05

    NeolifeBar Fruit and Nuts Bars Recalled for Listeria Contamination Risk

    Natural Formulas is recalling NeolifeBar Fruit & Nuts bars because they contain sunflower kernels under recall for possible Listeria monocytogenes contamination.

    Product
    NeolifeBar: Fruit & Nuts; 10 g Protein; 5 g Fiber. 320 mg Omega-3s. Net Wt. 1.6 oz. (45 g). Product is sold as a package of 15 bars: Distributed by GNLD International, LLC, Fremont, CA. Not sold in retail stores
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2404-2016·2016-10-05

    Bounce Energy Balls Recalled for Potential Listeria Contamination

    Bounce Life Style HQ is recalling Bounce Energy Ball Cashew & Pecan Vitality Lift due to potential Listeria monocytogenes contamination from recalled sunflower kernels.

    Product
    Bounce Energy Ball Cashew & Pecan Vitality Lift, each loose unit has net wt 42 gram. The bulk pack (contains 60 pieces) has UPC 9335805000872 and 9335805000308. The jar (contains 40 pieces) has UPC 9335805000254. Bounce Energy Ball Cashew & Pecan Vitality Lift unit has UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2464-2016·2016-10-05

    Grassfields Cheese Recalls Organic Raw Milk Cheese Due to E. Coli Risk

    Grassfields Cheese, LLC is recalling organic raw milk Leyden cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Leyden 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Devices)·Z-2783-2016·2016-10-05

    Anspach Effort Recalls Light Adaptors for Small Battery Drive Devices

    The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.

    Product
    Light Adaptor for Small Battery Drive and Small Battery Drive II.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2466-2016·2016-10-05

    Grassfields Lamont Cheddar Recalled for E. coli Contamination Risk

    Grassfields Cheese is recalling Lamont Cheddar due to potential Shiga toxin-producing E. coli contamination that can cause serious illness.

    Product
    Lamont Cheddar 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk c
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2403-2016·2016-10-05

    Bounce Life Style HQ Recalls Cashew Cinnamon for Listeria Risk

    Bounce Life Style HQ is recalling Cashew Cinnamon products due to potential Listeria monocytogenes contamination from recalled sunflower kernels.

    Product
    Australia -Cashew Cinnamon - Caf¿ Bounce, each bulk bag contains 60 pieces, and has UPC 29335805000494
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2461-2016·2016-10-05

    Grassfields Organic Raw Milk Gouda Cheese Recalled for E. coli Risk

    Grassfields Cheese is recalling organic raw milk Gouda cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Gouda 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2463-2016·2016-10-05

    Grassfields Cheese Recalls Organic Raw Milk Country Dill for E. coli Risk

    Grassfields Cheese, LLC is recalling organic raw milk Country Dill cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Country Dill 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk che
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2470-2016·2016-10-05

    Grassfields Cheese Recalls Organic Raw Milk Crofters Cheese

    Grassfields Cheese, LLC is recalling organic raw milk Crofters cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Crofters 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2468-2016·2016-10-05

    Grassfields Cheese Recalls Organic Raw Milk Cheese for E. coli Risk

    Grassfields Cheese, LLC is recalling organic raw milk cheese due to potential contamination with Shiga toxin-producing E. coli (STEC).

    Product
    Fait Fras 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-2467-2016·2016-10-05

    Grassfields Organic Raw Milk Chili Cheese Recalled for E. coli Risk

    Grassfields Cheese is recalling organic raw milk Chili Cheese due to potential Shiga toxin-producing E. coli contamination that can cause serious illness.

    Product
    Chili Cheese 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk che
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-1546-2016·2016-10-05

    Vital Care Compounder Recalls Olopatadine Eye Drops for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Olopatadine 0.8% Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1548-2016·2016-10-05

    Vital Care Compounder Recalls Hyaluronidase Vials Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 23 vials of Hyaluronidase due to a lack of assurance of sterility. The affected lot was distributed in Mississippi.

    Product
    Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2883-2016·2016-10-05

    Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1529-2016·2016-10-05

    Vital Care Compounder Recalls Chlorpheniramine Maleate Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 108 vials of Chlorpheniramine Maleate 10 mg/ml due to lack of assurance of sterility.

    Product
    Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1532-2016·2016-10-05

    Vital Care Compounder Recalls Moxifloxacin and Dexamethasone Eye Drops

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Moxifloxacin and Dexamethasone ophthalmic vials due to a lack of assurance of sterility.

    Product
    Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml, Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1545-2016·2016-10-05

    FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/ATROP 150/5/5 injection vials due to a lack of assurance of sterility.

    Product
    C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1541-2016·2016-10-05

    FDA Recalls Autologous Serum Tears Due to Sterility Assurance Concerns

    The FDA is recalling Autologous Serum Tears from Vital Care Compounder due to a lack of assurance of sterility. The product was distributed in Mississippi.

    Product
    Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2605-2016·2016-10-05

    Dean Foods Recalls Old Style Meadow Gold Heavy Whipping Cream

    Dean Foods is recalling 60 pints of Old Style Meadow Gold Heavy Whipping Cream due to insufficient pasteurization. The product was distributed in Idaho, Oregon, Wyoming, and Utah.

    Product
    Old Style Meadow Gold Heavy Whipping Cream Grade A Pint (473 mL) in waxed cardboard container
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2880-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1543-2016·2016-10-05

    FDA Recalls Pre-Op Pledget Soln + Tetracaine Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln + Tetracaine vials because the agency cannot ensure the product is sterile.

    Product
    Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1542-2016·2016-10-05

    FDA Recalls Pre-Op Pledget Ophthalmic Drops Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling Pre-Op Pledget Soln ophthalmic drops due to a lack of assurance of sterility. The recall affects 6 vials distributed in Mississippi.

    Product
    Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1544-2016·2016-10-05

    FDA Recalls Hydroxyzine HCl Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. is recalling 139 vials of Hydroxyzine HCl injection in Mississippi due to a lack of assurance of sterility.

    Product
    Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1531-2016·2016-10-05

    Vital Care Compounder Recalls Apomorphine HCl Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling Apomorphine HCl 3mg/ml Sterile Injection Solution due to a lack of assurance of sterility.

    Product
    Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1539-2016·2016-10-05

    Morphine Sulfate Injection Recalled for Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Morphine Sulfate 15mg/ml Injection due to a lack of assurance of sterility. The product was distributed in Mississippi.

    Product
    Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1540-2016·2016-10-05

    FDA Recalls Methylcobalamin Vials Due to Lack of Sterility Assurance

    Pharmacy Plus, Inc. is recalling Methylcobalamin 5,000mcg/ml vials due to lack of assurance of sterility. The recall affects 36 vials distributed in Mississippi.

    Product
    Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V709000·2016-10-05

    NHTSA Recalls 2015-2016 Wells Cargo and Haulmark Snowmobile Trailers

    Universal Trailer Cargo Group is recalling 89 aluminum snowmobile trailers because cross winds may cause them to tip or lift, potentially tearing the couplers.

    Product
    WELLS CARGO — WELLS CARGO, HAULMARK ALUMINUM SNOWMOBILE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1547-2016·2016-10-05

    FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/Atrop 150/7.5 injection vials due to a lack of assurance of sterility.

    Product
    C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1535-2016·2016-10-05

    FDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine and Prostaglandin vials due to a lack of assurance of sterility.

    Product
    Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·16V712000·2016-10-05

    Daimler Recalls 2017 Thomas Built Buses Saf-T-Liner C2 School Bus Chassis

    Daimler Trucks North America is recalling 162 model year 2017 Thomas Built Buses Saf-T-Liner C2 school bus chassis because the brake transmission shift interlock may be inoperable.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2603-2016·2016-10-05

    Meadow Gold Dairy Half & Half Recalled for Insufficient Pasteurization

    Dean Foods is recalling Meadow Gold Dairy Pure Fresh Half & Half due to insufficient pasteurization. The product was distributed in Idaho, Oregon, Wyoming, and Utah.

    Product
    Meadow Gold Dairy Pure Fresh Half & Half One Quart (946 mL)
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1533-2016·2016-10-05

    FDA Recalls Vital Care Compounder Eye Drops for Sterility Concerns

    The FDA is recalling specific lots of MOXI/DEX/KETOROLAC eye drops from Vital Care Compounder due to a lack of assurance of sterility.

    Product
    MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1534-2016·2016-10-05

    Vital Care Compounder Recalls Papaverine and Phentolamine Vials Due to Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine 150 mg / Phentolamine 5 mg vials due to a lack of assurance of sterility.

    Product
    Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2402-2016·2016-10-05

    Bounce Apple Cinnamon Protein Energy Balls Recalled for Listeria Risk

    Bounce Life Style HQ is recalling Apple Cinnamon Protein Energy Balls due to potential Listeria monocytogenes contamination from sunflower kernels.

    Product
    US - Bounce Apple Cinnamon Protein Punch Energy Balls (old name), net wt. 1.48 oz. (42g). Product UPC Codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes). US - Bounce Apple Cinnamon Protein Energy Balls (new name), net wt. 1.48 oz. (42g). Product UPC co
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1538-2016·2016-10-05

    Vital Care Compounder Recalls Moxifloxacin HCl Eye Drops for Sterility Concerns

    Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 16 vials of Moxifloxacin HCl eye drops due to a lack of assurance of sterility.

    Product
    Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-2401-2016·2016-10-05

    Eastern Feast Green Raisin Recall for Undeclared Sulfites

    Commerce International Inc. is recalling Eastern Feast Green Raisin due to undeclared sulfites on the label.

    Product
    Eastern Feast, Green Raisin, 7 oz plastic container.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2879-2016·2016-10-05

    CareFusion Recalls Alaris Syringe Modules Due to Software Anomaly

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units with software version 9.15 because a software anomaly may cause infusions to stop unexpectedly.

    Product
    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2016·2016-10-05

    Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.

    Product
    PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2895-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,063 sterile administration sets due to a potential filter leaking defect. The sets are distributed nationwide for use with infusion pumps or gravity feed.

    Product
    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a conta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2888-2016·2016-10-05

    Spiegelberg Brain Pressure Monitoring Probes Recalled for Measurement Errors

    Spiegelberg is recalling 22 Brain Pressure Monitoring System probes due to air chamber shrinkage that caused false high readings in the lower measuring range.

    Product
    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2016·2016-10-05

    Anspach Effort Recalls Small Battery Drive Adaptors Due to Burst Risk

    The Anspach Effort, Inc. is recalling 1,833 Small Battery Drive adaptors worldwide because they may generate excessive internal pressure and burst.

    Product
    Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2617-2016·2016-10-05

    Federico's Mexican Cookies Recalled for Undeclared Milk Allergen

    Federico's Bakery is recalling Mexican Cookies because they contain undeclared milk as a sub-ingredient in butter.

    Product
    Federico's Mexican Cookies Excelente Variedad, Net Wt. 21oz, 10packs/case, UPC 9154450521.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2885-2016·2016-10-05

    Spacelabs Xhibit Central Station Recalled for System Lockups and Alarm Failures

    Spacelabs Healthcare is recalling Xhibit Central Stations because the telemetry system may go offline, lock up, or fail to display audio and visual alarms for asystole.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2385-2016·2016-10-05

    Faribault Foods Recalls No-Salt-Added Black Beans for Foreign Material

    Faribault Foods is recalling 15 oz. No-Salt-Added Black Beans due to the potential presence of plastic and/or metal pieces.

    Product
    No-Salt-Added Black Beans, 15 oz. (425 g), packaged under the following brands: 1. HEB, UPC 41220-91262; 2. Kuner's UPC 72273-13613. Distributed by Kuner-Empson, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN 55021; 3. Mrs. Grimes, UPC 71891-
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-2600-2016·2016-10-05

    Ducal Apple Nectar Recalled Due to Arsenic Contamination

    Global Garlic, Inc. is recalling Ducal Apple Nectar because a surveillance sample tested positive for arsenic above 10 ppb.

    Product
    Ducal Apple Nectar, 5.3 oz cans.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2604-2016·2016-10-05

    Dean Foods Recalls Meadow Gold Heavy Whipping Cream Due to Pasteurization Issues

    Dean Foods is recalling specific containers of Meadow Gold Heavy Whipping Cream because they were not pasteurized sufficiently. Consumers in Idaho, Oregon, Wyoming, and Utah should check their products.

    Product
    Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Gallon (3.78L) in plastic one gallon container; Fresh Meadow Gold Dairy Pure Heavy Whipping Cream Half Pint (236 mL) in waxed cardboard carton; Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Quart (946mL) in waxed cardb
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2894-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2601-2016·2016-10-05

    Frozen Cinnamon Rolls Recalled for Missing Egg Allergen Labeling

    Top Taste, Inc. is recalling frozen cinnamon rolls because the labels list egg as an ingredient but fail to include it in the 'Contains' allergen statement.

    Product
    Frozen cinnamon rolls packaged under the following labels: (1) Fetting's Cinnamon Rolls, packaged in 15-oz. plastic bags, 8 rolls per bag, 15 bags per case, product #79211, UPC #075812792115. The firm name on the label is Top Taste, Inc., Finley, ND; and (2) Abby's Bakery
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2193-2016·2016-10-05

    GFS Honey Roasted Peanuts Recalled for Undeclared Tree Nuts

    Krispak Inc. is recalling GFS Honey Roasted Peanuts because they may contain undeclared tree nuts (pecans).

    Product
    GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·16V710000·2016-10-05

    Altec Recalls 2014-2015 Aerial Devices Due to Boom Tip Cover Defect

    Altec is recalling 219 model year 2014-2015 aerial devices because an improperly sized boom tip cover opening may allow contact with energized conductors, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 114,081 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients' vascular systems.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a contai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2876-2016·2016-10-05

    Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.

    Product
    ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2882-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels. The recall affects strips and kits distributed in the US and internationally.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2896-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2290-2016·2016-10-05

    Whole Foods Recalls 365 Everyday Value Mango Frozen Fruit Bars

    Whole Foods Market is recalling 365 Everyday Value Mango Frozen Fruit Bars due to undeclared coconut. The product was distributed in 30 states and Canada.

    Product
    365 Everyday Value Mango Frozen Fruit Bars 4 Bars-4 fl. oz. (118 mL) each-Net 16 fl. oz. (472 mL) in a cardboard carton, UPC: 0-99482-41344-6, Distributed By: Whole Foods Market Austin, Texas 78703
    Category
    Food
    Distribution
    29 states
  • HighNHTSA·16V711000·2016-10-05

    Western Star Trucks Recall for Seat Belt Mounting Plate Defect

    Daimler Trucks North America is recalling 2014-2017 Western Star 4900 and 5700 trucks because a seat belt mounting plate may have a hole that is too large, increasing injury risk in a crash.

    Product
    WESTERN STAR — WESTERN STAR 5700, 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2881-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2016·2016-10-05

    Siemens Syngo RT Therapist Software Recalled for Safety Issues

    Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.

    Product
    Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positionin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2016·2016-10-05

    Spacelabs Xhibit Telemetry Receiver Recall for System Lockups

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers because the system may go offline or lock up, potentially failing to display alarms.

    Product
    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2898-2016·2016-10-05

    Medtronic Recalls CareLink iPro Software Due to Time Stamp Error

    Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.

    Product
    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1525-2016·2016-10-05

    Pharmatech Recalls Senexon Liquid Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling Senexon Liquid (sennosides) 8.8 mg bottles nationwide as a precautionary measure due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1520-2016·2016-10-05

    Pharmatech Recalls Sennazon Syrup Due to Potential B. cepacia Contamination

    Pharmatech LLC is recalling 1,008 bottles of Sennazon (sennosides) Syrup nationwide due to a potential risk of contamination with B. cepacia bacteria.

    Product
    Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
    Category
    Drug
    Distribution
    Distributed nationwide

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