The Recall Desk

Archive

August 2017 recalls

1,004 recalls were announced in August 2017.

What the numbers show

Critical
75
Severe
178
High
462
Moderate
267
Low
22

Of the 1,004 recalls this month scored against our rubric, 7% are Critical, 18% are Severe.

Which agencies issued them

101–200 of 1004

  • HighFDA (Food)·F-3420-2017·2017-08-30

    Mary's Harvest Vegetable Snacks Recalled for Potential E. coli O26 Contamination

    Mary's Harvest Fresh Foods is recalling specific vegetable snack and tray products due to potential contamination with E. coli O26.

    Product
    Mary's Harvest brand, Vegetable Snack Pack, 6/12 oz packages, UPC 0 9250440001 1. Mary's Harvest brand, Vegetable Tray, 3/36 oz packages, UPC 0 9250472267 0. Mary's Harvest brand, Vegetable Tray Segment, 2/58 oz packages, UPC 0 9250475790 0. Kroger (QFC and Fred…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-3401-2017·2017-08-30

    Shatto Milk Ice Cream Sammich Recalled for Undeclared Allergens

    Shatto Milk Company is recalling 126 bags of Ice Cream Sammich products due to undeclared milk and wheat allergens.

    Product
    Oatmeal, Oatmeal Raisin Cookie And Caramel Sea Salt, Ice Cream Sammich, packaged in 5 oz plastic bags. Shatto Milk Company, Osborn, MO.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-3057-2017·2017-08-30

    Medtronic AxiEM ENT Suction Kits Recalled for Verification Failure

    Medtronic is recalling eight AxiEM ENT suction kits because the instruments fail mandatory pre-use verification tests.

    Product
    Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3056-2017·2017-08-30

    Medtronic Fusion ENT Instrument Kit Recalled for Verification Failure

    Medtronic is recalling 15 Fusion ENT Instrument Kits because the instruments fail pre-use verification. The kits were distributed in the US and Canada.

    Product
    Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3399-2017·2017-08-30

    Shatto Milk Ice Cream Sandwiches Recalled for Undeclared Allergens

    Shatto Milk Company is recalling Choc + Chip ice cream sandwiches because they contain undeclared milk and wheat allergens.

    Product
    Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, packaged in 4.5 oz plastic bags. Shatto Milk Company, Osborn, MO.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-3436-2017·2017-08-30

    Penobscot McCrum Recalls Seasoned Jo-Jo Wedges for Undeclared Milk

    Penobscot McCrum LLC is recalling 5,782 cases of Medium Seasoned/Battered Jo-Jo Wedges because the product may contain undeclared milk.

    Product
    Medium Seasoned/Battered Jo-Jo Wedges / 00129 (5 lb bags)
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Food)·F-3410-2017·2017-08-30

    Zydot Detox Drink Recalled for Undeclared Yellow #5 Dye

    Zydot Unlimited is recalling 9,101 bottles of Zydot Ultimate Blend Detox Drink because the product contains undeclared Yellow #5 dye.

    Product
    Zydot Ultimate Blend Detox Drink Natural Tropical Ice Flavor 32 fl. oz. (946 ml) and 16 fl. oz. (473 ml) packaged in clear plastic bottles
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1113-2017·2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 60 mg, due to a label mixup that may result in mislabeling.

    Product
    Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1114-2017·2017-08-30

    Phenobarbital Tablets Recalled for Potential Labeling Errors

    C. O. Truxton is recalling Phenobarbital Tablets USP, 100 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3062-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 500 Due to Seal Integrity

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 500 because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3465-2017·2017-08-30

    The Best Bar Ever Recalls Peanut Butter Crunch Bars Due to Labeling Error

    The Best Bar Ever Inc. is voluntarily recalling Peanut Butter Crunch bars because the individual wrappers incorrectly display a gluten-free logo, although the product ingredients and allergen statements are accurate.

    Product
    The Best Bar Ever, Peanut Butter Crunch, 1.41 oz., 40 gm.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-3055-2017·2017-08-30

    Medtronic ENT Instrument Set Recalled for Verification Failure

    Medtronic is recalling 13 reusable ENT instrument sets because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.

    Product
    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3046-2017·2017-08-30

    Cardinal Health Recalls Mispackaged Robotic Surgical Drapes

    Cardinal Health 200, LLC is recalling 200 units of Robotic Drape with Leggings that were incorrectly packaged as LAVH drapes.

    Product
    Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3068-2017·2017-08-30

    Pentax Ultrasound Video Gastroscope Recall Due to Instruction Error

    Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1115-2017·2017-08-30

    C. O. Truxton Recalls Mislabeled Amitriptyline HCL Tablets

    C. O. Truxton is recalling specific lots of Amitriptyline HCL 50 mg tablets due to potential label mixups. The recall is nationwide.

    Product
    Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3053-2017·2017-08-30

    Medtronic Curved Suction 90 Recalled for Verification Failure

    Medtronic is recalling 75 Curved Suction 90 ENT instruments because they fail required pre-use verification checks.

    Product
    Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1118-2017·2017-08-30

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 3,440 bottles of Phentermine Hydrochloride capsules because stability tests showed out-of-specification unknown impurities.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3067-2017·2017-08-30

    Pentax Ultrasound Video Gastroscope Recalled for Incorrect Disinfection Instructions

    Pentax of America Inc. is recalling 118 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.

    Product
    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2812-2017·2017-08-30

    Ito En Recalls Royal Mills Iced Cappuccino Due to Quality Complaints

    Ito En (USA) Inc. is recalling 38 cases of Royal Mills Iced Cappuccino after receiving complaints of sour taste, off odor, and sediment.

    Product
    Royal Mills, Iced Cappuccino, Premium Coffee. 11.0 FL. OZ. (325 ml) 2-piece aluminum can; Made in Hawaii. UPC: 0 73366 12755
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1116-2017·2017-08-30

    C. O. Truxton Recalls Phenobarbital Tablets Due to Labeling Error

    C. O. Truxton is recalling specific lots of Phenobarbital Tablets USP, 15 mg, due to a label mixup that may result in mislabeled products.

    Product
    Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V533000·2017-08-29

    Autocar Recalls 2015-2016 Xpeditor Vehicles for Steering Defect

    Autocar is recalling 85 Xpeditor vehicles because a steering component may loosen, potentially causing a complete loss of steering and increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V525000·2017-08-29

    Crane LET2 Trucks Recalled for Potential Steering Loss

    Crane Carrier is recalling 2015-2016 LET2 vehicles because a loose tie rod could cause complete loss of steering.

    Product
    CRANE — CRANE LET2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V536000·2017-08-29

    Volvo Recalls 2016 VNL and VNM Trucks for Steering Defect

    Volvo is recalling 2016 VNL and VNM trucks because a loose tie rod may cause complete loss of steering, increasing crash risk.

    Product
    VOLVO — VOLVO VNM, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17212·2017-08-29

    Fabri-Tech Recalls Infant Rompers Due to Choking Hazard

    Fabri-Tech is recalling about 6,500 infant shortall rompers sold at Cracker Barrel because shoulder buttons can detach, posing a choking hazard to children.

    Product
    Infant rompers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V527000·2017-08-28

    KME Recalls 2016 Predator Vehicles Due to Steering Defect

    KME is recalling 2016 Predator Pumper, Rescue, and Airport Refueler vehicles because a loose tie rod could cause a complete loss of steering.

    Product
    KME — KME PREDATOR PUMPER, PREDATOR RESCUE, AIRPORT REFUELER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E048000·2017-08-28

    Ford Recalls Wheel Hub Bearings for 2011-2017 Explorer 4X2 Vehicles

    Ford is recalling certain wheel hub bearing assemblies for 2011-2017 Ford Explorer 4X2 vehicles because they lack a self-retention feature, which could cause the wheel to separate.

    Product
    FORD — FORD EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V531000·2017-08-28

    Triton Recalls 2017 W-25 Trailers Due to Axle Bolt Tightening Defect

    Triton Trailers is recalling 2017 W-25 Single Torsion Axle Trailers because improperly tightened axle mounting bolts may cause the axle to detach, increasing crash risk.

    Product
    TRITON — TRITON W-25
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V529000·2017-08-28

    Ford Recalls 2017 F-150 and Mustang for Air Bag Inflator Defect

    Ford is recalling 2017 F-150 and Mustang vehicles because the passenger air bag inflator may rupture in a crash, potentially causing serious injury or death.

    Product
    FORD — FORD F-150, MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V528000·2017-08-28

    Ford Recalls 2017 Focus Vehicles for Rear Seat Back Weld Defect

    Ford is recalling 2017 Focus vehicles because an insufficient weld on the rear left seat back may reduce its strength, increasing injury risk in a crash.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V530000·2017-08-28

    Ford Recalls 2017 Models for Steering Gear Heat Shield Fastener Defect

    Ford is recalling 2017 Explorer, Taurus, and Police Interceptor vehicles because steering gear heat shield fasteners may corrode and detach, potentially causing overheating and increased steering effort.

    Product
    FORD — FORD EXPLORER, TAURUS, POLICE INTERCEPTOR SEDAN, POLICE INTERCEPTOR UTILIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V532000·2017-08-28

    Hyundai Recalls 2017 Ioniq Electric Vehicles for Electronic Power Control Unit Defect

    Hyundai is recalling 2017 Ioniq Electric vehicles because a manufacturing defect in the Electronic Power Control Unit may allow coolant to contact the circuit board, potentially causing a stall and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI IONIQ ELECTRIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V526000·2017-08-28

    Ford Recalls F-150 and F-250 Trucks for Seat Belt Defect

    Ford is recalling 2015-2017 F-150 and 2017 F-250/F-350 trucks because the left rear inflatable seat belt buckle may detach, increasing injury risk.

    Product
    FORD — FORD F-150, F-250 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·098-2017·2017-08-26

    Blossom Foods Recalls Frozen Meat Products Due to Undeclared Allergens

    Blossom Foods is recalling approximately 15,092 pounds of frozen beef, chicken, and pork products because they contain undeclared soy and wheat allergens.

    Product
    Blossom Foods, LLC — Blossom Foods, LLC Recalls Frozen Meat Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereUSDA FSIS·097-2017·2017-08-26

    Ronald A. Chisholm Recalls Pork Belly Products Lacking Import Inspection

    Ronald A. Chisholm, Ltd. is recalling skinless pork belly products that entered the U.S. without import inspection. The products were distributed to restaurants in Hawaii.

    Product
    Ronald A. Chisholm, Ltd. Recalls Pork Belly Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·17V523000·2017-08-25

    Forest River Recalls 2018 XLR ToyHaulers for Incorrect Tire Placard Information

    Forest River is recalling 2018 XLR ToyHaulers because the Federal Placard may display incorrect tire and rim specifications, potentially leading to the installation of incorrect replacement tires.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·096-2017·2017-08-25

    DiLuigi Foods Recalls Chicken Sausage for Undeclared Soy Allergen

    DiLuigi Foods is recalling Trader Joe's chicken breakfast sausage because the product contains undeclared soy lecithin, a known allergen.

    Product
    DiLuigi Foods Inc. Recalls Chicken Sausage Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    13 states
  • SevereNHTSA·17V521000·2017-08-24

    Western Star 4900 Trucks Recalled for Front Axle Spring Defect

    Daimler Trucks North America is recalling 2017-2018 Western Star 4900 trucks because front axle weight capacity may exceed spring capacity, risking axle separation.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V522000·2017-08-24

    Thor Motor Coach Recalls 2018 RVs for Propane Hose Leak Risk

    Thor Motor Coach is recalling 2018 Four Winds, Chateau, and Freedom Elite recreational vehicles because a liquid propane hose may sag and pinch, potentially causing a leak and fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM ELITE, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17211·2017-08-24

    Dr. Martens Vegan Boots Recalled for Benzidine Chemical Exposure Hazard

    Airwair is recalling Dr. Martens Vegan 1460 boots in cherry red because the tongue lining contains benzidine. Consumers should stop using the boots and contact Dr. Martens for a refund or replacement.

    Product
    Dr. Martens Vegan boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1092-2017·2017-08-23

    GEC LX Laxoplex Recalled for Undeclared Anabolic Steroids

    Genetic Edge Compounds LLC is recalling GEC LX Laxoplex dietary supplements because FDA analysis found the product tainted with undeclared anabolic steroids and steroid-like substances.

    Product
    GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3378-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Paleo Double Dark Chocolate Chip bars due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Paleo Double Dark Chocolate Chip; Paleo Egg White Protein: Net Wt 1.6 oz. (45 G)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3375-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Apple Chunk Cinnamon Nutmeg bars due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Apple Chunk Cinnamon Nutmeg; Vegan Organic Pea Protein Net Wt. 1.6 oz (45G)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3383-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Dark Chocolate Coconut Almond products due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Dark Chocolate Coconut Almond
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1087-2017·2017-08-23

    Biotech Underground Tri-Ton Hardcore Formula Recalled for Unapproved Ingredients

    Dynamic Technical Formulations is recalling Biotech Underground Tri-Ton Hardcore Formula capsules because FDA testing found unapproved drug ingredients.

    Product
    Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3376-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Protein Bars for Listeria Risk

    Laura's Boston Brownies is recalling specific Bhufit protein bars due to potential Listeria monocytogenes contamination. Consumers should check lot codes and stop eating the product.

    Product
    Bhufit Bar Chocolate Tart Cherry Pistachio; Vegan Organic Pea Protein Net Wt. 1.6 oz. (45G)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3379-2017·2017-08-23

    Laura's Boston Brownies Recalls Peanut Butter Protein Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Peanut Butter White Chocolate Vegan Organic Pea Protein bars due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Peanut Butter White Chocolate; Vegan Organic Pea Protein: Net Wt. 1.6 oz. (45G)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3381-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Vanilla Almond Cashew bars due to potential Listeria monocytogenes contamination. Consumers should stop eating these products.

    Product
    Bhufit Bar Vanilla Almond Cashew, Primal Grass-Fed Whey Protein: Net. Wt. 1.6 oz. (45G)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3377-2017·2017-08-23

    Laura's Boston Brownies Recalls Peanut Butter Chocolate Chip Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Peanut Butter Chocolate Chip bars due to potential Listeria monocytogenes contamination. The recall affects 62,951 bars distributed in the US.

    Product
    Bhufit Bar Peanut Butter Chocolate Chip; Vegan Organic Pea Protein;Net Wt. 1.6 oz. (45G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-3367-2017·2017-08-23

    NatureAll Acidophilus-Plus Recalled for Undeclared Milk Allergens

    NatureAll is recalling Acidophilus-Plus dietary supplements because they contain undeclared milk allergens, including colostrum, dried yogurt, and whey.

    Product
    Acidophilus-Plus, No. 102, 90 Capsules, Dietary Supplement,
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3038-2017·2017-08-23

    Boston Scientific Recalls Emblem MRI S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 9,200 Emblem MRI S-ICD devices because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1085-2017·2017-08-23

    Hardcore Formulations Recalls D-ZINE Rapid Size and Strength Capsules

    Hardcore Formulations is recalling D-ZINE Rapid Size and Strength capsules because they contain unapproved active ingredients.

    Product
    D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3034-2017·2017-08-23

    Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

    Cenorin, LLC is recalling 18 ThermaSure Series 1000 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

    Product
    ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009; (b) Model 1010 Forced air dryer for medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·095-2017·2017-08-23

    USDA Recalls Chicken Skewers Due to Possible Listeria Contamination

    Expresco Foods is recalling approximately 20,446 pounds of imported chicken skewer products that may be contaminated with Listeria monocytogenes.

    Product
    Expresco Foods Inc. Recalls Chicken Skewer Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-1096-2017·2017-08-23

    FDA Recalls Unapproved Caffeine Powder Marketed Without NDA Approval

    Global Marketing Enterprises is recalling 52.5 kg of unapproved caffeine powder marketed with stimulant claims and lacking adequate directions for use.

    Product
    Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine Nutrients Corp, 1801 S. Canal St, Chicago, IL 60616, UPC 021754905076
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1084-2017·2017-08-23

    FDA Recalls Ultra-Sten Capsules Marketed Without Approval

    Hardcore Formulations is recalling Ultra-Sten capsules because they contain unapproved ingredients and were marketed without an approved NDA or ANDA.

    Product
    ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1091-2017·2017-08-23

    ICU Medical Recalls 0.9% Sodium Chloride Injection Due to Particulate Matter

    ICU Medical Inc. is recalling 436,716 units of 0.9% Sodium Chloride Injection due to the presence of stainless steel particulate matter.

    Product
    0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3039-2017·2017-08-23

    Boston Scientific Recalls SQ-RX 1010 Pulse Generators Due to Memory Corruption

    Boston Scientific is recalling approximately 12,450 SQ-RX 1010 Pulse Generators because memory corruption may cause the device to deliver an atypical amount of energy.

    Product
    SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3037-2017·2017-08-23

    Boston Scientific Recalls Emblem S-ICD Devices Due to Energy Delivery Risk

    Boston Scientific is recalling approximately 16,750 Emblem S-ICD devices because they may deliver atypical energy levels due to internal memory corruption.

    Product
    EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3380-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling specific lots of Bhufit Bar Superfood Chocolate Chip Brownie Batter due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Superfood Chocolate Chip Brownie Batter; Vegan Organic Pea Protein; Net Wt. 1.6 oz. (45G)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1093-2017·2017-08-23

    Lupin Recalls Mibelas 24 Fe Contraceptive Tablets Due to Sequence Error

    Lupin Limited is recalling Mibelas 24 Fe tablets because the first four pills in the packet are brown instead of the last four, and the expiry/lot was not printed on the package.

    Product
    Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·17209·2017-08-23

    Nutrilife Recalls 29% Hydrogen Peroxide Bottles Due to Fire and Burn Hazards

    Nutrilife is recalling 29% hydrogen peroxide bottles because caps may not vent properly, allowing pressure to build and cause rupture, posing fire and burn risks.

    Product
    Nutrilife 29% hydrogen peroxide (H202) one-gallon bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3368-2017·2017-08-23

    FDA Recalls Metabo-Plus Dietary Supplement for Undeclared Milk Allergen

    NatureAll-STF Holding, LLC is recalling 254 bottles of Metabo-Plus dietary supplement because it contains undeclared milk (whey), a major allergen.

    Product
    Metabo-Plus, Garlic/Papaya Plus, No. 103, 90 Capsules, Dietary Supplement
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3366-2017·2017-08-23

    Aldi Gluten Free Hamburger Buns Recalled for Undeclared Eggs

    Silver Hills Bakery is recalling Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns due to undeclared eggs. The recall affects 9,639 retail units sold nationwide.

    Product
    Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns, 11.3 Ounces, in plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3369-2017·2017-08-23

    NatureAll Thymus Plus Recalled for Undeclared Milk Allergen

    NatureAll is recalling Thymus Plus dietary supplements because they contain undeclared milk. Consumers with milk allergies should not use the product.

    Product
    Thymus Plus, No. 114, 90 Capsules, Dietary Supplement
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3382-2017·2017-08-23

    Laura's Boston Brownies Recalls Bhufit Bars for Listeria Risk

    Laura's Boston Brownies is recalling Bhufit Bar Salted Caramel Pecan products due to potential Listeria monocytogenes contamination.

    Product
    Bhufit Bar Salted Caramel Pecan
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2720-2017·2017-08-23

    High Liner Breaded Fish Recalled for Undeclared Milk Allergen

    High Liner Foods is recalling Oven Ready Whole Grain Breaded Fish Sea Wonders due to potential undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    HFS 1/10 Oven Ready Whole Grain Breaded Fish Sea Wonders, Item Number: 26533
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2800-2017·2017-08-23

    High Liner Salmon Recalled for Undeclared Milk Allergen

    High Liner Foods is recalling Uppercrust Honey Chipotle Salmon nationwide due to undeclared milk, a major food allergen.

    Product
    HLSC 10LB Uppercrust Honey Chipotle Salmon 5.71oz., Item Number: A1222
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2675-2017·2017-08-23

    High Liner Recalls Beer Battered Fish Fillets Due to Undeclared Milk

    High Liner Foods Inc. is recalling Best Choice Beer Battered Fish Fillets because the product may contain undeclared milk.

    Product
    Best Choice 12/18.2oz Beer Battered Fish Fillets, Item Number: SB1401
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2762-2017·2017-08-23

    High Liner Alaska Pollock Sticks Recalled for Undeclared Milk

    High Liner Foods is recalling HFS 4/5 Oven Ready Whole Grain Breaded Alaska Pollock Sticks because the product may contain undeclared milk.

    Product
    HFS 4/5 Oven Ready Whole Grain Breaded Alaska Pollock Sticks. Item Number: 1089867
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2781-2017·2017-08-23

    High Liner Foods Recalls Breaded Alaska Pollock Nuggets for Undeclared Milk

    High Liner Foods is recalling Gordon Food Service breaded Alaska pollock nuggets because they may contain undeclared milk.

    Product
    Gordon Food Service 2/5LB Whole Grain Breaded Alaska Pollock Nugget 1oz ., Item Number: 10026693
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2669-2017·2017-08-23

    High Liner Foods Recalls Potato Crusted Cod for Undeclared Milk

    High Liner Foods Inc. is recalling Potato Crusted Cod because the product may contain undeclared milk. The recall covers 693,408 cases distributed nationwide.

    Product
    HLSC 12/10oz Potato Crusted Cod, Item Number: S1029440
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2647-2017·2017-08-23

    Sea Cuisine Herb Crusted Cod Recalled for Undeclared Milk

    High Liner Foods is recalling Sea Cuisine Herb Crusted Cod because it may contain undeclared milk.

    Product
    Sea Cuisine 1/10lb Herb Crusted Cod, Item Number: A1405
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2646-2017·2017-08-23

    High Liner Foods Recalls Honey Chipotle Salmon for Undeclared Milk

    High Liner Foods is recalling Sea Cuisine Honey Chipotle Salmon nationwide due to potential undeclared milk, a major allergen.

    Product
    Sea Cuisine 20/10.75oz Honey Chipotle Salmon, Item Number: A1344
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2650-2017·2017-08-23

    Sea Cuisine Tilapia Recalled for Undeclared Milk Allergen

    High Liner Foods is recalling Sea Cuisine Pan Sear Garlic & Herb Tilapia because the product may contain undeclared milk.

    Product
    Sea Cuisine 8/9 oz., Pan Sear Garlic & Herb Tilapia, Item Number: A1468
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2692-2017·2017-08-23

    High Liner Foods Recalls Raw Breaded Alaska Pollock Nuggets for Undeclared Milk

    High Liner Foods is recalling raw breaded Alaska pollock nuggets because they may contain undeclared milk. The recall covers 693,408 cases distributed nationwide.

    Product
    FPI 1/10 Crunchy Lites Raw Breaded Alaska Pollock Nuggets 0.85 oz.., Item Number: 06230
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3019-2017·2017-08-23

    Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

    Cyberonics is recalling 396 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause the devices to lose power faster than expected.

    Product
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2743-2017·2017-08-23

    High Liner Breaded Fish Shapes Recalled for Undeclared Milk

    High Liner Foods is recalling breaded fish shapes because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    HFS 1/10 Precooked Ovenready Breaded Formed Fish Shapes 0.875 oz., Item Number: 1005172
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2780-2017·2017-08-23

    High Liner Foods Recalls Breaded Pollock for Undeclared Milk

    High Liner Foods is recalling Gordon Food Service breaded pollock because it may contain undeclared milk. The recall covers 693,408 cases distributed nationwide.

    Product
    Gordon Food Service 1/10LB Whole Grain Breaded Pollock 3.6oz , Item Number: 10026691
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2784-2017·2017-08-23

    High Liner Foods Recalls Cod Fillets Due to Undeclared Milk

    High Liner Foods is recalling Guinness Beer Battered Cod Fillets because they may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Icelandic 1/10LB Guinness Beer Battered Cod Fillets 2oz., Item Number: 10026731
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2629-2017·2017-08-23

    High Liner Recalls Viking Breaded Cod Fillets for Undeclared Milk

    High Liner Foods Inc. is recalling Viking Precooked Breaded Cod Fillets because they may contain undeclared milk.

    Product
    Viking 12/1lb Precooked Breaded Cod Fillets 4 oz., Item Number 02620
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2797-2017·2017-08-23

    High Liner Recalls Beer Battered Pollock for Undeclared Milk

    High Liner Foods Inc. is recalling Viking Beer Battered Pollock nationwide due to potential undeclared milk.

    Product
    Viking 2/5lb Beer Battered Pollock 2oz., Item Number: 06092R
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2674-2017·2017-08-23

    High Liner Recalls Breaded Fish Sticks for Undeclared Milk

    High Liner Foods is recalling Big Y Breaded Minced Fish Sticks because they may contain undeclared milk.

    Product
    Big Y 12/25oz Breaded Minced Fish Sticks, Item Number: SB1202
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2732-2017·2017-08-23

    High Liner Potato Breaded Pollock Wedges Recalled for Undeclared Milk

    High Liner Foods is recalling specific lots of Potato Breaded Pollock Wedges because they may contain undeclared milk.

    Product
    HFS 1/10.35 lb Whole Grain Oven Ready Potato Breaded Pollock Wedges 3.6 oz,, Item Number: 53364
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2763-2017·2017-08-23

    High Liner Alaska Pollock Sticks Recalled for Undeclared Milk

    High Liner Foods is recalling HFS 4/5 Oven Ready Whole Grain Breaded Alaska Pollock Sticks because the product may contain undeclared milk.

    Product
    HFS 4/5 Oven Ready Whole Grain Breaded Alaska Pollock Sticks. Item Number: 1089867
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2790-2017·2017-08-23

    High Liner Foods Recalls Chicken Fried Shrimp for Undeclared Milk

    High Liner Foods is recalling Sysco Chicken Fried Shrimp because the product may contain undeclared milk.

    Product
    Sysco 2/5lb Chicken Fried Shrimp 18-24 ct., Item Number: 10026807
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2759-2017·2017-08-23

    Nestle Pollock Portions Recalled for Undeclared Milk Allergen

    High Liner Foods is recalling Nestle Pollock Formed Breaded Portions due to undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    Nestle 1/30lb 147.42 gram Pollock Formed Breaded Portions Parfried. Item Number: 1089838
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2801-2017·2017-08-23

    High Liner Foods Recalls Honey Chipotle Crusted Salmon for Undeclared Milk

    High Liner Foods is recalling Sea Cuisine Honey Chipotle Crusted Salmon because the product may contain undeclared milk.

    Product
    Sea Cuisine 20/10.75oz Honey Chipotle Crusted Salmon - Foam Tray. Item Number: A1344
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2727-2017·2017-08-23

    High Liner Recalls Precooked Breaded Cod Nuggets for Undeclared Milk

    High Liner Foods Inc. is recalling precooked breaded cod nuggets because they may contain undeclared milk.

    Product
    SCHWAN 8/2 LB PRECOOKED BREADED COD NUGGET, 0.5 OZ. CANADA PRODUCED. Item Number: 51154
    Category
    Food
    Distribution
    Distributed nationwide

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