The Recall Desk

Archive

May 2016 recalls

603 recalls were announced in May 2016.

What the numbers show

Critical
27
Severe
108
High
210
Moderate
211
Low
47

Of the 603 recalls this month scored against our rubric, 4% are Critical, 18% are Severe.

301–400 of 603

  • SevereFDA (Food)·F-1304-2016·2016-05-11

    North Fish USA Recalls Cold Smoked Sliced Fish Assorted

    North Fish USA is recalling cold smoked sliced fish due to unsanitary conditions and inadequate HACCP plans found by Florida regulators.

    Product
    Cold smoked Sliced Fish Assorted (cold smoked Salmon and Escolar), 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1536-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Conductivity Sensors Due to Leakage Risk

    B Braun Medical Inc is recalling 147 Dialog+ Hemodialysis Conductivity Sensors due to potential leakage. The sensors are used in dialysis machines for kidney failure patients.

    Product
    Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis cen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1317-2016·2016-05-11

    NORVEN Herring in Oil Recalled for Listeria Contamination

    OLMA-XXI Inc. is recalling NORVEN herring in oil due to Listeria monocytogenes contamination found by FDA sampling.

    Product
    NORVEN herring in oil, Net Wt. 17.6 oz. (500g), UPC barcode 856687004196, and Net Wt. 10.6 oz. (300g), UPC barcode 856687004189 -- Product of Ukraine -- Distributed by: OLMA-XXI Inc. 204 28th Street, Brooklyn, NY 11232
    Category
    Food
    Distribution
    13 states
  • SevereNHTSA·16V285000·2016-05-11

    Forest River Recalls 2016-2017 Berkshire and Cross Country RVs for Sway Bar Defect

    Forest River is recalling specific 2016-2017 Berkshire and 2016 Cross Country recreational vehicles because front sway bar brackets may not fit properly, risking detachment and crashes.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN BERKSHIRE, CROSS COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V291000·2016-05-11

    Keystone Recalls 2016-2017 Passport Trailers Due to Axle Defect

    Keystone RV Company is recalling specific 2016-2017 Passport trailers because they were built with axles that have lower capacity than required, increasing the risk of axle failure and a crash.

    Product
    KEYSTONE — KEYSTONE PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V284000·2016-05-11

    2016 Jeep Cherokee Recall for Right Halfshaft Fracture Risk

    Chrysler is recalling 2016 Jeep Cherokee vehicles because the right halfshaft may fracture without warning, increasing crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1531-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 370 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide and in Puerto Rico.

    Product
    Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1313-2016·2016-05-11

    Sincere Orient Thin Egg Noodles Recalled for Undeclared Wheat

    Sincere Orient Commercial Foods Corp. is recalling Thin Egg Noodles (Mi Trung Ga) because they contain undeclared wheat.

    Product
    Thin Egg Noodle (Mi Trung Ga), 5lbs, 8 units/case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1301-2016·2016-05-11

    North Fish USA Recalls Sliced Cold Smoked Escolar Due to Sanitation Issues

    North Fish USA is recalling sliced cold smoked Escolar because it was not produced under an adequate HACCP plan and was held in unsanitary conditions.

    Product
    Sliced cold smoked Escolar, 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1310-2016·2016-05-11

    Specialty Produce Recalls Diced Red Potatoes for Undeclared Sulfites

    Specialty Produce Corporation is recalling diced red potatoes in Rhode Island due to undeclared sulfites. The recall was initiated voluntarily by the firm.

    Product
    Diced Red Potatoes, hand labeled: "Potato, Red Dice, 40# 3/4 large"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1295-2016·2016-05-11

    North Fish USA Recalls Cold Smoked White Fish Due to Sanitation Issues

    North Fish USA is recalling cold smoked white fish because it was not produced under an adequate HACCP plan and was held in unsanitary conditions.

    Product
    Cold smoked white fish, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1532-2016·2016-05-11

    B Braun Dialog+ Hemodialysis Machines Recalled for Potential Sensor Leakage

    B Braun Medical Inc. is recalling 40 Dialog+ Hemodialysis machines due to a potential leakage issue with conductivity sensors.

    Product
    Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1303-2016·2016-05-11

    North Fish USA Recalls Cold Smoked Mackerel Due to Sanitation Issues

    North Fish USA is recalling cold smoked mackerel because it was not produced under an adequate HACCP plan and was held in unsanitary conditions.

    Product
    Cold smoked Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1606-2016·2016-05-11

    CareFusion Alaris PC Unit Model 8015 Recalled for Power-Up Error

    CareFusion 303, Inc. is recalling 23,397 Alaris PC units, Model 8015, because a super capacitor failure may cause a system error code at power-up.

    Product
    Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2016·2016-05-11

    Siemens MAGNETOM MRI Systems Recalled Due to Magnetic Table Cover Hazard

    Siemens is recalling eight MAGNETOM Aera/Skyra MRI systems because the patient table's docking station cover may contain a magnetic plate that attracts to the main magnet.

    Product
    MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915. Docking station top cover (part no# 10591430) of the removable patient table.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1306-2016·2016-05-11

    Meijer Plain Knot Rolls Recalled for Undeclared Peanuts

    R.W. Bakers Co. is recalling Meijer Plain Knot Rolls and Assorted Dinner Rolls due to potential undeclared peanuts.

    Product
    Meijer Plain Knot Rolls, 8 ct., Net Wt. 10 oz.; 12/case, 9.4 lbs/case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1312-2016·2016-05-11

    QTrade Recalls Organic Chamomile Tea Due to Salmonella Risk

    QTrade Teas & Herbs is recalling Organic Chamomile Tea Bag Cut because it may be contaminated with Salmonella. The product was distributed in New Jersey and Ohio.

    Product
    Organic Chamomile Tea Bag Cut (TBC) bulk sold in original cases (25kg bags), Bulk product 25 kg craft paper bags "L 0609-13681-238641-01 ORGANIC CHAMOMILE TBC CERTIFIED ORGANIC MATRICARIA CHAMOMILLA 25KG NET ORIGIN: COSOVO WORLEE HAMBURG"
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1611-2016·2016-05-11

    Applied Medical Recalls Wilson Implantation System Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 1,100 units of the Wilson Implantation System after a complaint revealed an open pouch that breached sterilization validation.

    Product
    Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1299-2016·2016-05-11

    North Fish USA Recalls Hot Smoked Atlantic Ocean Perch for Sanitation Issues

    North Fish USA is recalling hot smoked Atlantic Ocean Perch because the Florida Department of Agriculture found the products were not produced under an adequate HACCP plan and were held in unsanitary conditions.

    Product
    Hot smoked Atlantic Ocean Perch, vacuumed package, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1103-2016·2016-05-11

    Trigal Coconut Arepas Recalled for Undeclared Sodium Metabisulfite Allergen

    Pastry Food Products Inc. is recalling Trigal Coconut Flavored Arepas due to undeclared sodium metabisulfite. The product was distributed in Puerto Rico.

    Product
    Trigal***Arepas de Coco (Coconut Flavored Arepas)***Mant¿ngase refrigerado (Keep refrigerated)***Peso Neto 1.12 lb (509 g)***Paquete de 12 (12 units package)***Manufacturado Por (Manufactured by): Pastry Foods Inc.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1610-2016·2016-05-11

    Applied Medical Recalls Wilson Penile Implantation System Retractor Frame

    Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1101-2016·2016-05-11

    Pastry Food Products Recalls TRIGAL Empanadillas for Undeclared Allergens

    Pastry Food Products Inc. is recalling TRIGAL Empanadillas Sabor a Carne due to undeclared yellow #5 and soy protein. The product was distributed in Puerto Rico.

    Product
    TRIGAL*** Empanadillas Sabor a Carne (meat flavored turnovers)***Peso neto 3 lbs (Net Weight 3 pounds)*** Pqte. de 12 (12 units package)***Pastry Foods Inc. Rio Piedras PR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1589-2016·2016-05-11

    GE Revolution CT Recalled for Potential X-Ray Tube Loosening

    GE Medical Systems is recalling 26 Revolution CT systems worldwide because a manufacturing error may cause the X-ray tube to loosen, leading to scan errors or image artifacts.

    Product
    GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1293-2016·2016-05-11

    Emerald Cashew Packs Recalled for Potential Glass Fragments

    Diamond Foods is recalling Emerald 100 Calorie Packs of Cashew Halves & Pieces due to the potential for small glass fragments in the product.

    Product
    Emerald 100 Calorie Packs of Cashew Halves & Pieces, roasted and salted. 7 pack/ 0.62 oz. each (17.5 g). Ingredients: Cashews, Vegetable Oil/Safflower, Sunflower and/or Canola Oil, Salt, Rosemary extract (to preserve freshness: Retail Carton UPC: 0 10300 33324 1; Inner Pa
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1586-2016·2016-05-11

    Ab Sciex Analyst MD Software Recall for Incorrect Diagnostic Results

    Ab Sciex is recalling Analyst MD software versions 1.6.1 and 1.6.2 because it may display wrong quantitative results, potentially leading to incorrect patient diagnoses.

    Product
    Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2016·2016-05-11

    Applied Medical Technology Recalls Self-Retaining Retractor Frames Due to Sterilization Breach

    Applied Medical Technology is recalling 3,754 units of TLC Self-Retaining Retractor Frames because a complaint reported an open pouch, which breaches sterilization validation.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighCPSC·16158·2016-05-11

    Bosch Small Angle Grinders Recalled for Overheating and Burn Risk

    Robert Bosch Tool Corp. is recalling about 91,000 Bosch 1380 Slim small angle grinders because they can overheat, melt brush covers, and expose hot components, posing a burn risk.

    Product
    Bosch small angle grinders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V286000·2016-05-11

    Great Lakes Drywall Pup Trailers Recalled for Rear Impact Guard Defect

    Great Lakes is recalling 1998-2016 Drywall Pup trailers because rear impact guards do not meet federal safety standards, increasing injury risk in crashes.

    Product
    GREAT LAKES — GREAT LAKES DRYWALL PUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1102-2016·2016-05-11

    Pastry Food Products Recalls Unlabeled Potato Balls for Undeclared Allergens

    Pastry Food Products Inc. is recalling unlabeled Rellenos de Papa in Puerto Rico due to undeclared yellow #5, soy protein, and sodium bisulfite.

    Product
    Rellenos de Papa (meat flavored potato balls): This product is distributed without label.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1305-2016·2016-05-11

    North Fish USA Recalls Hot Smoked Escolar Chunks Due to Sanitation Issues

    North Fish USA is recalling 40 packages of hot smoked Escolar chunks because they were not produced under an adequate HACCP plan and were held in unsanitary conditions.

    Product
    Hot smoked Escolar chunks, vacuum packaged, one chunk per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·16V289000·2016-05-11

    Pacific Coachworks Recalls 2016 Rage'N Toy Haulers for Label Error

    Pacific Coachworks is recalling 2016 Rage'N toy haulers because an incorrect Cargo Carrying Capacity value on the Federal Information label could lead to overloading.

    Product
    PACIFIC COACHWORKS — PACIFIC COACHWORKS RAGE'N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2016·2016-05-11

    Nuvectra Algovita Spinal Cord Stimulation Programmer Recall for Software Defect

    Nuvectra is recalling 17 Algovita Spinal Cord Stimulation System Clinical Programmers (Model 4500) because a software defect may prevent users from recharging the implantable pulse generator.

    Product
    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1534-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage Risk

    B Braun Medical Inc is recalling 90 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1533-2016·2016-05-11

    B Braun Recalls Dialog+ Hemodialysis Machines Due to Sensor Leakage

    B Braun Medical Inc is recalling 318 Dialog+ Hemodialysis machines because conductivity sensors may leak. The recall covers units distributed nationwide.

    Product
    Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1311-2016·2016-05-11

    Wise Foods Recalls Potato Chips With Undeclared Wheat Allergen

    Wise Foods is recalling 400 bags of Cha-Ching Original Potato Chips because the packaging was filled with BBQ Seasoned product containing undeclared wheat.

    Product
    Cha-Ching Original Potato Chips Net Wt 10 OZ.; Distributed by OZA Brands, LLC, Salisbury, NC 28147
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1300-2016·2016-05-11

    North Fish USA Recalls Hot Smoked Mackerel Due to Sanitary Issues

    North Fish USA is recalling hot smoked mackerel because the Florida Department of Agriculture found it was not produced under an adequate HACCP plan and was held in unsanitary conditions.

    Product
    Hot smoked Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1596-2016·2016-05-11

    bioMerieux Recalls VITEK 2 Gram Positive Susceptibility Test Cards

    bioMerieux is recalling VITEK 2 Gram Positive Susceptibility Test Cards because they may produce false susceptible results for specific bacteria to Minocycline.

    Product
    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibi
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1297-2016·2016-05-11

    North Fish USA Recalls Salted Herring Due to Sanitary Violations

    North Fish USA is recalling salted herring because it was not produced under an adequate HACCP plan and was held in unsanitary conditions.

    Product
    Salted Herring in pail, 30 pieces per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1307-2016·2016-05-11

    R.W. Bakers Recalls Dinner Rolls for Undeclared Peanuts

    R.W. Bakers Co. is recalling specific packages of dinner rolls and plain knot rolls because they may contain undeclared peanuts.

    Product
    Assorted Dinner Rolls, 128 ct., Net Wt. 10.2 lbs; 16/ 8 ct./case
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1294-2016·2016-05-11

    DMH Ingredients Recalls Organic Lemon Myrtle Due to Salmonella

    DMH Ingredients Inc is recalling 20 cases of Organic Lemon Myrtle because the product tested positive for Salmonella. The product was distributed to one manufacturer in New Jersey.

    Product
    Organic Lemon Myrtle packed in a 12.5kg plastic bag inside of a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1608-2016·2016-05-11

    Applied Medical Recalls TLC Self Retaining Retractor Systems Due to Sterilization Breach

    Applied Medical Technology Inc is recalling 5,334 units of TLC Self Retaining Retractor Systems because a complaint reported an open pouch that breaches sterilization validation.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Food)·F-1302-2016·2016-05-11

    North Fish USA Recalls Cold Smoked Saury Due to Sanitary Violations

    North Fish USA is recalling cold smoked saury because the Florida Department of Agriculture found the products were not produced under an adequate HACCP plan and held in unsanitary conditions.

    Product
    Cold smoked Saira (Saury), vacuum packaged, 3 pieces per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1601-2016·2016-05-11

    Siemens Syngo Dynamics PACS Software Recall for Workflow Error

    Siemens is recalling 84 units of Syngo Dynamics software due to a defect that may cause old measurements to be carried forward into new reports.

    Product
    Syngo Dynamics; Kinetdx Picture Archiving and Communications System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·040-2016·2016-05-11

    Ajinomoto Windsor Recalls Meat and Poultry Products Due to Listeria Risk

    Ajinomoto Windsor is recalling approximately 47 million pounds of not-ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination.

    Product
    Ajinomoto Windsor Inc. — Ajinomoto Windsor, Inc. Recalls Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1319-2016·2016-05-11

    Vaughan Foods Recalls La Fiesta Bean Salad for Undeclared Wheat

    Vaughan Foods is recalling La Fiesta Bean Salad tubs because they contain undeclared wheat. The product was distributed in five states.

    Product
    La Fiesta Bean Salad (2/5 LB Tubs) Made By Fresh Creative Foods Moore, OK 73160 UPC 013454371763 packaged in white plastic tub with lid
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1157-2016·2016-05-11

    Iowa Select Herbs Recalls Chamomile Flowers for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling chamomile flowers because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Chamomile Flowers (Chamomilla recutita), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1174-2016·2016-05-11

    Iowa Select Herbs Fennel Seed Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Fennel Seed under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Fennel Seed (Foeniculum vulgara), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1215-2016·2016-05-11

    Iowa Select Herbs Recalls Reishi Mushroom Product Due to Misbranding

    Iowa Select Herbs LLC is recalling Reishi Mushroom products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Reishi Mushroom (Ganoderma Lucidum), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1189-2016·2016-05-11

    Iowa Select Herbs Recalls Kava Kava Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Kava Kava Root products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Kava Kava Root (Piper methysticum), www.iowaselectherbs.com, (a) 2 fl. Oz., (b) 4 fl. Oz., (c) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1167-2016·2016-05-11

    Iowa Select Herbs Recalls Damiana Leaf Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Damiana Leaf because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Damiana Leaf (Turnera diffusa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1169-2016·2016-05-11

    Iowa Select Herbs Recalls Dandelion Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Dandelion Root products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Dandelion Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1158-2016·2016-05-11

    Iowa Select Herbs Recalls Chaparral Leaf Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Chaparral Leaf dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Chaparral Leaf (Larrea tridentata), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1603-2016·2016-05-11

    Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error

    Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.

    Product
    Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-1156-2016·2016-05-11

    Iowa Select Herbs Recalls Cat's Claw Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling Cat's Claw dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Cat's Claw (Uncaria tomentosa), www.iowaselectherbs.com, 7.5 Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1190-2016·2016-05-11

    Iowa Select Herbs Recalls Lemon Balm Leaf for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Lemon Balm Leaf products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Lemon Balm Leaf (Melissa officinalis), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 4 fl. Oz., (c) 8 fl. Oz., (d) 16 fl. Oz., (e) 32 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1210-2016·2016-05-11

    Iowa Select Herbs Recalls Propolis Resin Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Propolis Resin because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Propolis Resin (Ligustrum lucidum), 2 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1143-2016·2016-05-11

    Iowa Select Herbs Recalls Atractylodes for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Atractylodes (Atractylodes macrocephala) under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC,Atractylodes (Atractylodes macrocephala), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1162-2016·2016-05-11

    Iowa Select Herbs Recalls Citrus Peel Product for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Citrus Peel (Uncaria tomentosa) because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC,Citrus Peel (Uncaria tomentosa), www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1230-2016·2016-05-11

    Iowa Select Herbs Recalls White Willow Bark for Misbranding

    Iowa Select Herbs LLC is recalling White Willow Bark products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, White Willow Bark, www.iowaselectherbs.com, (a) 16 fl. Oz. (b) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2016·2016-05-11

    Livongo Health Recalls In Touch Blood Glucose Monitoring System Inserts

    Livongo Health is recalling 63,000 units of the In Touch Blood Glucose Monitoring System because the instructional insert omitted specific sensor accuracy limitations.

    Product
    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Food)·F-1144-2016·2016-05-11

    Iowa Select Herbs Bayberry Root Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Bayberry Root products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Bayberry Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1206-2016·2016-05-11

    Iowa Select Herbs Recalls Red Ginseng Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Red Ginseng Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Red Ginseng Root (Panax ginseng), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2016·2016-05-11

    Alcon Recalls INFINITI Ultrasound Packs Due to Tubing Leakage

    Alcon Research is recalling INFINITI Ultrasound Packs because the irrigation line tubing may leak near the white luer.

    Product
    INFINITI Ultrasound Pack. Catalog Numbers: 8065751716, 8065751717, 8065751718, 8065751720, 8065751721, 8065751723. An ophthalmic microsurgical system indicated for phacoemulsification and removal of cataracts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1184-2016·2016-05-11

    Iowa Select Herbs Hawthorn Berry Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Hawthorn Berry dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Hawthorn Berry (Crateagus oxycanthus), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1154-2016·2016-05-11

    Iowa Select Herbs Recalls Burdock Root Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Burdock Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Burdock Root, www.iowaselectherbs.com, 4 fl. Oz.., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1139-2016·2016-05-11

    Iowa Select Herbs Recalls Arnica Flowers for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 10 bottles of Arnica Flowers because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Arnica Flowers, www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1604-2016·2016-05-11

    Ferno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels

    Ferno-Washington Inc. is recalling 270 traction splint strap kits because the outside packaging labels for adult and pediatric sizes were swapped.

    Product
    Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg.
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-1159-2016·2016-05-11

    Iowa Select Herbs Recalls Alcohol-Free Chicory Root Due to Misbranding

    Iowa Select Herbs LLC is recalling 1-gallon bottles of Alcohol-Free Chicory Root because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Chicory Root, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1221-2016·2016-05-11

    Iowa Select Herbs Recalls Saw Palmetto Berry Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Saw Palmetto Berry products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Saw Palmetto Berry (Serenoa repens), www.iowaselectherbs.com, (a) 4 fl. Oz. (b) 16 fl. Oz., (c) 32 fl. Oz., (d) unknown size., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1148-2016·2016-05-11

    Iowa Select Herbs Recalls Black Cohosh Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Black Cohosh Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Black Cohosh Root, www.iowaselectherbs.com, 1 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1186-2016·2016-05-11

    Iowa Select Herbs Recalls Jerusalem Artichoke for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 4 fl. oz. bottles of Jerusalem Artichoke because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Jerusalem Artichoke www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1593-2016·2016-05-11

    Carestream Image Suite V3 Recalled for Incorrect Image Annotation

    Carestream Health is recalling Image Suite V3 units due to a software error that displays incorrect left/right image annotations.

    Product
    CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F IMG ST/ POC&VITA /INDIA: REF/Catalog # 1036425 -- Made in USA by: Carestream Hea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1236-2016·2016-05-11

    Iowa Select Herbs Recalls Magnolia Bark for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 1-gallon bottles of Magnolia Bark because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Magnolia Bark www.iowaselectherbs.com, 1 Gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1161-2016·2016-05-11

    Iowa Select Herbs Recalls Cinnamon Bark for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Cinnamon Bark products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Cinnamon Bark (Cinnamomum cassia), www.iowaselectherbs.com, (a) 1 fl. Oz..(b) 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1592-2016·2016-05-11

    Siemens ACUSON SC2000 Ultrasound System Recalled for Trackball Control Failure

    Siemens is recalling 87 ACUSON SC2000 ultrasound systems because the trackball may fail to control specific imaging parameters during transesophageal procedures.

    Product
    ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model number: 10433816.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1216-2016·2016-05-11

    Iowa Select Herbs Recalls Rhodiola Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Rhodiola Root products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Rhodiola Root, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1217-2016·2016-05-11

    Iowa Select Herbs Recalls Rhubarb Root Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Rhubarb Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Rhubarb Root (Rhizoma rhei), www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1235-2016·2016-05-11

    Iowa Select Herbs Recalls Dandelion Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 1-gallon bottles of Alcohol-Free Dandelion Root because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Alcohol-Free, Dandelion Root, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1309-2016·2016-05-11

    Strong America Recalls Welltop Fried Dace for Leucomalachite Green

    Strong America Limited is recalling Welltop Fried Dace because FDA sampling found leucomalachite green. The product was distributed in New York.

    Product
    Welltop Fried Dace, Net Weight 184g, Product of China, packed for Hui Zhou Welltop Foods Import and Export Co. Ltd. Importer: Guong Aik Sdn. Bhd No. 13 Long Bridge Road, PO Box 1056, 96008, Sibu, Sarawak, East Malaysia, Importer Strong America Ltd, 2-39 54th Ave., Long Island Cit
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1152-2016·2016-05-11

    Iowa Select Herbs Recalls Broad Beans for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Broad Beans because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Broad Beans, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1218-2016·2016-05-11

    Iowa Select Herbs Recalls Alcohol-Free Sage Leaf Due to Misbranding

    Iowa Select Herbs LLC is recalling alcohol-free Sage Leaf products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alcohol-free, Sage Leaf, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1220-2016·2016-05-11

    Iowa Select Herbs Recalls Sassafras Root Bark Due to Misbranding

    Iowa Select Herbs LLC is recalling Sassafras Root Bark because it is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Sassparilla Smilax uti lis, www.iowaselectherbs.com, 7.5 fl. Oz.., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1137-2016·2016-05-11

    Iowa Select Herbs Recalls Alisma Leaf Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Alisma Leaf products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alisma Leaf, www.iowaselectherbs.com, 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1142-2016·2016-05-11

    Iowa Select Herbs Recalls Astragalus Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Astragalus Root products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Atragalus Root (Astragalus Membranaceus), www.iowaselectherbs.com, (a) 1 fl. Oz., (b) 2 fl. Oz., (c) 4 fl. Oz., and (d) 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1173-2016·2016-05-11

    Iowa Select Herbs Recalls Eleuthero Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Eleuthero Root under a consent decree because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Eleuthero Root (Eleutherococcus senticosus), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1135-2016·2016-05-11

    Iowa Select Herbs Recalls Acia Berry Supplement Due to Misbranding

    Iowa Select Herbs LLC is recalling 10 bottles of Acia Berry dietary supplement because the product is misbranded, an unapproved new drug, and an adulterated supplement.

    Product
    Iowa Select Herbs LLC, Acia Berry (Euterpe oleracea), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1177-2016·2016-05-11

    Iowa Select Herbs Recalls Ginger Root for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Ginger Root products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Ginger Root (Zingiber officinale), www.iowaselectherbs.com, (a) 2 fl. Oz. (b) 4 fl. Oz. (c) 7.5 fl. Oz., (d) 1 gallon, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1223-2016·2016-05-11

    Iowa Select Herbs Recalls Scullcap Supplement Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 4 fl. oz. bottles of Scullcap (Scutellaria lateriflora) because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Scullcap (Scutellaria lateriflora), www.iowaselectherbs.com, 4 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1227-2016·2016-05-11

    Iowa Select Herbs Turmeric Recalled for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Turmeric products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Tumeric, www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2016·2016-05-11

    Iowa Select Herbs Recalls Propolis Supplement for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Propolis (Ligustrum lucidum) supplements because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Propolis (Ligustrum lucidum), 4 fl. Oz., www.iowaselectherbs.com, Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1181-2016·2016-05-11

    Iowa Select Herbs Recalls Soursop Leaf Product for Misbranding

    Iowa Select Herbs LLC is recalling Graviola Leaf "Soursop" products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Graviola Leaf "Soursop" (Annona muricata), www.iowaselectherbs.com, (a) 4 fl. Oz., (b) 16 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1151-2016·2016-05-11

    Iowa Select Herbs Recalls Boswellia Serrata for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Boswellia Serrata dietary supplements because they are misbranded, unapproved new drugs, and adulterated.

    Product
    Iowa Select Herbs LLC, Boswellia Serrata, www.iowaselectherbs.com, 1 gallon., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1178-2016·2016-05-11

    Iowa Select Herbs Recalls Ginkgo Biloba for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Ginkgo biloba products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Ginkgo Leave (Ginkgo biloba), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1140-2016·2016-05-11

    Iowa Select Herbs Recalls Artichoke Leaf Extract for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling 10 bottles of Artichoke Leaf extract because the product is misbranded, an unapproved new drug, and an adulterated dietary supplement.

    Product
    Iowa Select Herbs LLC, Artichoke Leaf (Cynara Scolymus), www.iowaselectherbs.com, 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1141-2016·2016-05-11

    Iowa Select Herbs Recalls Ashwaganda Root Due to Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Ashwaganda Root products because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Ashwaganda Root (Withania somnifera), www.iowaselectherbs.com, (a) 1 fl. Oz. and (b) 4 fl. Oz. (120 ml), Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1136-2016·2016-05-11

    Iowa Select Herbs Recalls Alfalfa Leaf for Misbranding and Adulteration

    Iowa Select Herbs LLC is recalling Alfalfa Leaf products under a consent decree because they are misbranded, unapproved new drugs, and adulterated dietary supplements.

    Product
    Iowa Select Herbs LLC, Alfalfa Leaf (Medicago sativa), www.iowaselectherbs.com, 7.5 fl. Oz., Cedar Rapids, IA 52402
    Category
    Food
    Distribution
    Distributed nationwide

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