The Recall Desk

Archive

March 2014 recalls

554 recalls were announced in March 2014.

What the numbers show

Critical
40
Severe
147
High
238
Moderate
117
Low
12

Of the 554 recalls this month scored against our rubric, 7% are Critical, 27% are Severe.

301–400 of 554

  • SevereFDA (Drugs)·D-1123-2014·2014-03-12

    Methotrexate Intraocular Recall Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all unexpired lots of Methotrexate Intraocular 400mcg 0.1cc due to quality control issues affecting sterility assurance.

    Product
    Methotrexate Intraocular 400mcg 0.1cc
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1103-2014·2014-03-12

    Cyanocobalamin Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Cyanocobalamin 100mcg/ml injection due to quality control issues affecting sterility assurance.

    Product
    Cyanocobalamin 100mcg/ml injection
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1105-2014·2014-03-12

    Natures Pharmacy Recalls Cyano B-12 Due to Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling Cyano B-12 (Cmpd) 1000mcg/ml due to quality control issues affecting sterility assurance.

    Product
    Cyano B-12 (Cmpd) 1000mcg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1140-2014·2014-03-12

    Vancomycin Eye Drops Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Vancomycin (fortified) 25mg/ml ophthalmic solution due to quality control issues affecting sterility assurance.

    Product
    Vancomycin (fortified) 25mg/ml opth
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1148-2014·2014-03-12

    Fresenius Kabi Recalls Heparin Sodium Injection Due to Subpotency

    Fresenius Kabi is recalling Heparin Sodium Injection vials because they may contain less active ingredient than labeled.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1115-2014·2014-03-12

    Gentamycin Injection Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Gentamycin 80mg/1000cc 0.9% NS due to quality control issues affecting sterility assurance.

    Product
    Gentamycin 80mg/1000cc 0.9% NS
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1150-2014·2014-03-12

    Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk

    Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.

    Product
    Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1597-2014·2014-03-12

    Rise n Roll Bakery Recalls Caramel Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling Caramel Donuts because they contain egg, which is not listed on the label. Consumers with egg allergies should not eat the product.

    Product
    Rise n Roll Bakery & Deli, Caramel Donuts, sold individually and found in 6 count (436 g)UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Caramel Donuts Enriched wheat flour, soybean oil, dextrose,
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1084-2014·2014-03-12

    Elekta Agility Software Recall for Calibration Input Errors

    Elekta is recalling Agility software version 3.0 because incorrect values can be entered during calibration procedures for medical linear accelerators.

    Product
    Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1611-2014·2014-03-12

    Tonia's Biscotti Sampler Bag Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Sampler Bags due to undeclared wheat, soy, and milk.

    Product
    Sampler Bag Biscotti consists of 3 pieces of Almond dipped in Dark Chocolate; 3 pieces of Cranberry dipped in White Chocolate; and 3 pieces of Cranberry & Toasted Almonds. Sampler Bag is packaged in white windowed paper coated bakery bags and sold under Tonia's Biscotti brand.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1596-2014·2014-03-12

    Rise n Roll Bakery Apple Fritters Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling Apple Fritters because they contain an undeclared egg ingredient, posing a risk to individuals with egg allergies.

    Product
    Rise n Roll Bakery & Deli, Apple Fritter, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Apple Fritter Enriched wheat flour, apples, soybean oil, de
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1119-2014·2014-03-12

    Greatbatch Medical Recalls Offset Cup Impactor Due to Sterility Assurance Concerns

    Greatbatch Medical is recalling Standard Offset Cup Impactors because internal testing showed the specified sterilization cycles may not achieve the required sterility assurance level.

    Product
    Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861, T13344, T13480, T13642, T13722, T13999, T14155, T14384,
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·14V119000·2014-03-12

    Zero Motorcycles Recalls 2014 Models Due to Motor Rotor Contact

    Zero Motorcycles is recalling specific 2014 FX, S, DS, and SR models because the motor rotor may contact the stator, potentially causing the rear wheel to lock up and increasing crash risk.

    Product
    ZERO — ZERO S, DS, SR, FX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1612-2014·2014-03-12

    Yukon Concessions Recalls Lemon Biscotti for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Lemon Biscotti dipped in White Chocolate due to undeclared wheat, soy, and milk.

    Product
    Lemon Biscotti dipped in White Chocolate Bag, 13 oz., sold in white windowed paper coated bakery bags, And individually wrapped in cellophane - net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1082-2014·2014-03-12

    Elekta Desktop Pro Linear Accelerator Control Software Recalled for Calibration Errors

    Elekta, Inc. is recalling Desktop Pro linear accelerator control software because incorrect values may be entered during calibration procedures.

    Product
    Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2014·2014-03-12

    Carestream Recalls Kodak 2200 Intraoral X-Ray Systems Due to Arm Failure

    Carestream Health is recalling Kodak 2200 Intraoral X-Ray Systems because the device arms may break early. This affects 347 units distributed in the US and Canada.

    Product
    Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc. Made in France -- --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraoral with timer --- There are four major componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2014·2014-03-12

    Elekta Integrity Software Recalled for Calibration Input Errors

    Elekta, Inc. is recalling Integrity Version 1.1 software for linear accelerators because incorrect values can be entered during calibration procedures.

    Product
    Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1614-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti almond dipped in dark chocolate due to undeclared wheat, soy, and milk.

    Product
    Almond dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1595-2014·2014-03-12

    Rise n Roll Bavarian Creme Donuts Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling Bavarian Creme Donuts because they contain an undeclared egg ingredient, posing a risk to individuals with egg allergies.

    Product
    Rise n Roll Bakery & Deli, Bavarian Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Bavarian Creme Donuts Enriched wheat flour, soybea
    Category
    Food
    Distribution
    11 states
  • HighFDA (Drugs)·D-1147-2014·2014-03-12

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Particulate Matter

    Hospira Inc. is recalling 115,500 vials of Bupivacaine Hydrochloride injection due to a confirmed report of visible particulate matter embedded in the glass vials.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1143-2014·2014-03-12

    Phillips Respironics Recalls Trilogy Ventilators Due to Power Board Defect

    Phillips Respironics is recalling 572 Trilogy ventilators worldwide because a defective power management board component may cause loss of therapy.

    Product
    Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1147-2014·2014-03-12

    GE Healthcare Recalls Solar 8000M/i Patient Monitors Due to AVOA Feature Failure

    GE Healthcare is recalling Solar 8000M and 8000i patient monitors because the Automatic-View-On-Alarm feature may stop functioning after a specific discharge event.

    Product
    GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1081-2014·2014-03-12

    Elekta RT Desktop Software Recall for Calibration Input Errors

    Elekta is recalling RT Desktop software because users may enter incorrect values during calibration procedures for radiation therapy linear accelerators.

    Product
    RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a lic
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-1085-2014·2014-03-12

    Elekta Agility software recall for potential calibration input errors

    Elekta is recalling Agility software version 3.1 for linear accelerators because incorrect values could be entered during calibration procedures.

    Product
    Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14129·2014-03-12

    Fitbit Recalls Force Activity-Tracking Wristband Due to Skin Irritation Risk

    Fitbit is recalling Force activity-tracking wristbands because the materials can cause skin irritation, rashes, or blistering. Consumers should contact Fitbit for a full refund.

    Product
    Wireless activity-tracking wristband
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1621-2014·2014-03-12

    Mandarin Orange Tozzetti Biscotti Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Mandarin Orange Tozzetti Biscotti due to undeclared wheat, soy, and milk.

    Product
    Mandarin Orange Tozzetti Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1618-2014·2014-03-12

    Tonia's Biscotti Chocolate Delight Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Chocolate Delight due to undeclared wheat, soy, and milk.

    Product
    Chocolate Delight dipped in Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1134-2014·2014-03-12

    DeRoyal Circumcision Clamps Recalled for Manufacturing Defects

    DeRoyal Industries is recalling three lots of circumcision clamps that may not clamp completely at the surgical site due to manufacturing errors.

    Product
    DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1127-2014·2014-03-12

    Carestream Recalls Kodak 2100 Intraoral X-Ray Systems Due to Arm Breakage

    Carestream Health is recalling Kodak 2100 Intraoral X-Ray Systems because the device arms may break early. The recall covers 347 units distributed in the US and Canada.

    Product
    Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 -- Made in France -- TROPHY 77435 Marne La Vallee --- COMMON/USUAL NAME: Dental X-Ray Systems -- CLASSIFICATION NAME: Unit, X-Ray, Extraora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1594-2014·2014-03-12

    Rise n Roll Chocolate Donuts Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling chocolate donuts because they contain undeclared egg, a major food allergen.

    Product
    Rise n Roll Bakery & Deli, Chocolate Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Chocolate Donuts Enriched wheat flour, soybean oil, dextro
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1619-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Cran-Almond Biscotti due to undeclared wheat, soy, and milk. The product was sold in Alaska and online.

    Product
    Cran-Almond Biscotti (cranberry & toasted almond) - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1616-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Traditional Toasted Almond Biscotti due to undeclared wheat, soy, and milk.

    Product
    Traditional Toasted Almond Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1593-2014·2014-03-12

    Rise n Roll White Powdered Donuts Recalled for Undeclared Egg

    Rise'n Roll Bakery is recalling White Powdered Donuts because they contain an undeclared egg ingredient, posing a risk to consumers with egg allergies.

    Product
    Rise n Roll Bakery & Deli, White Powdered Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties: White Powdered Donut : Enriched wheat flour, soybean
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1124-2014·2014-03-12

    Medical Information Technology Recalls MEDITECH Microbiology Calculator Module

    Medical Information Technology, Inc. is recalling MEDITECH Microbiology calculator modules due to a risk of patient results being removed from laboratory and electronic medical record systems.

    Product
    MEDITECH Microbiology - Calculator/data processing module, for clinical use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1599-2014·2014-03-12

    Rise n Roll Bakery Recalls Glazed Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling glazed donuts because they contain egg, which is not listed on the label.

    Product
    Rise n Roll Bakery & Deli, Glazed Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Glazed Donuts Enriched wheat flour, soybean oil, dextrose,
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1610-2014·2014-03-12

    Dairy Rich Chocolate Ice Cream Recalled for Potential Peanut Allergen

    Ice Cream Specialities is voluntarily recalling Dairy Rich Chocolate Ice Cream because it may contain peanut butter, a peanut allergen.

    Product
    Chocolate Ice Cream manufactured under the Dairy Rich brand and packaged in a 1.75 quart (1.66 L) (56 oz.) carton.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1608-2014·2014-03-12

    Deb-El Foods Recalls Dried Whole Eggs Due to Undeclared Milk

    Deb-El Food Products LLC is recalling dried whole eggs because they contain undeclared milk, a major food allergen.

    Product
    Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1598-2014·2014-03-12

    Rise n Roll Bakery Recalls Cinnamon Caramel Donuts for Undeclared Egg

    Rise'n Roll Bakery is recalling Cinnamon Caramel Donuts and Donut Holes because they contain an undeclared egg ingredient. The products were sold in multiple states and online.

    Product
    Rise n Roll Bakery & Deli, Cinnamon Caramel Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties and in Cinnamon Caramel Donut Holes, 1.05 lb, UPC Code
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-1602-2014·2014-03-12

    Rise'n Roll Bakery Recalls Amish Wedding Nutty Crunch for Undeclared Peanuts

    Rise'n Roll Bakery is recalling Amish Wedding Nutty Crunch products because they contain undeclared peanuts. The recall covers products with a best-by date of June 13, 2014, or earlier.

    Product
    Amish Wedding, Nutty Crunch, ... boiled to perfection, Distributed by Troyer Cheese, Inc. ... Millersburg, OH 44654, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·14V115000·2014-03-12

    Triple E Recalls 2014 Free Spirit Motorhomes Due to Obstructed Taillight

    Triple E Recreational Vehicles is recalling 2014 Free Spirit motorhomes because the spare tire carrier obstructs the driver's side taillight, increasing crash risk.

    Product
    FREE SPIRIT — FREE SPIRIT FS22, FS22TE, FS22SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2014·2014-03-12

    KCI USA Recalls Prevena Peel and Place System Kits

    KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1133-2014·2014-03-12

    BencoDental Tartar and Stain Remover Recalled for Incorrect Labeling

    Heraeus Kulzer is recalling BencoDental tartar and stain remover due to incorrect labeling on the immediate container.

    Product
    BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1129-2014·2014-03-12

    Medicamat Punch Hair Matic Recalled for Misbranded Marketing Literature

    Medicamat is recalling 71 units of the Punch Hair Matic surgical hair transplant device due to misbranded marketing literature.

    Product
    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1142-2014·2014-03-12

    KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty

    KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.

    Product
    PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and remo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1122-2014·2014-03-12

    WalkMed Recalls Triton FP Infusion Pumps Due to Labeling Error

    WalkMed Infusion is recalling 797 Triton FP Infusion Pumps because the label on the right side contains an incorrect instruction.

    Product
    Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospit
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1130-2014·2014-03-12

    DJO Surgical Recalls Mispackaged Acetabular Liners for Hip Replacement

    DJO Surgical is recalling 10 units of FMP X-alt Acetabular Liners that were mistakenly packaged and labeled as different models and sizes.

    Product
    FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Kits Due to Connector Issues

    KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.

    Product
    PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1126-2014·2014-03-12

    Hospira Recalls LifeShield Blood Sets Due to Assembly Errors

    Hospira Inc. is recalling specific lots of LifeShield Latex-Free HEMA Y-Type Blood Sets because they were assembled incorrectly.

    Product
    *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inquiries should be directed to Hospira, Inc., Lake Forest,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2014·2014-03-12

    Focus Diagnostics Recalls Simplexa Flu and RSV Assay Kits

    Focus Diagnostics is recalling Simplexa Flu A/B & RSV Direct Assay Kits due to the potential for false positive test results.

    Product
    Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1113-2014·2014-03-12

    Toshiba CT Systems Recalled for X-Ray Output Software Defect

    Toshiba is recalling 338 Aquilion CT systems because a software defect may prevent X-ray exposure from starting during contrast studies.

    Product
    TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2014·2014-03-12

    KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue

    KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.

    Product
    PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1060-2014·2014-03-12

    McKesson Anesthesia Care System Recalled for Data Mismatch

    McKesson Technologies is recalling 10 units of the Anesthesia Care system because patient case data did not match the patient data, including data from another case.

    Product
    McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and records data both through manual entry and from monitors which themselves are attached to patients, such as in the operating room environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1138-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty

    KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.

    Product
    PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1603-2014·2014-03-12

    Heart of the Valley Parsnips Recalled for Pesticide Residue

    Ed Fields & Sons, Inc. is recalling Heart of the Valley brand parsnips because they contained pesticide linuron above the maximum residue level.

    Product
    Heart of the Valley brand Parsnips, produce of U.S.A., packaged in the following sizes: 16 ounces (453 grams), UPC 31446-22016; 20 ounces (566 grams), UPC 31446-22020; 20 lb. bags; and 40 lb boxes
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1132-2014·2014-03-12

    Mako Surgical Recalls Restoris Multicompartmental Knee System Due to Mislabeling

    Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee System because the product may be mislabeled, which could result in the incorrect implant being used.

    Product
    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2014·2014-03-12

    KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues

    KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the ap
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0972-2014·2014-03-12

    Toshiba CT System Recalled Due to X-Ray Generator Failure

    Toshiba is recalling eight Aquilion One CT systems because high-voltage generator parts may fail, preventing X-ray exposure.

    Product
    TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0973-2014·2014-03-12

    Medtronic O-arm Imaging System Recalled for Labeling Compliance Gaps

    Medtronic is recalling O-arm Imaging Systems because a review found gaps in compliance with FDA labeling requirements for user information.

    Product
    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1065-2014·2014-03-12

    Elekta Digital Accelerators Recalled for Default Value Reset Issues

    Elekta, Inc. is recalling 472 digital accelerators because customers are resetting default values outside recommended factory settings.

    Product
    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2014·2014-03-12

    AlterG Anti-Gravity Treadmill Accessory Shorts Recalled for Unapproved Material

    AlterG, Incorporated is recalling 2,221 accessory shorts for the AlterG Anti-Gravity Treadmill because unapproved material caused them to stretch unusually, making them uncomfortable for patients.

    Product
    Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1125-2014·2014-03-12

    Synthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert

    Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.

    Product
    Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1135-2014·2014-03-12

    KCI Prevena Peel and Place System Kit Recalled for Connector Issues

    KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.

    Product
    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2014·2014-03-12

    KCI Recalls Prevena Incision Management System Due to Connector Difficulty

    KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.

    Product
    PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed envir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1092-2014·2014-03-12

    Teva Recalls Ethambutol Hydrochloride Tablets Due to Incorrect Excipient

    Teva Pharmaceuticals is recalling specific lots of Ethambutol Hydrochloride Tablets because they were manufactured with an unapproved gelatin excipient.

    Product
    Teva Ethambutol Hydrochloride Tablets, USP, 400 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA., NDC 0555-0923-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2014·2014-03-12

    GE Healthcare GSI Viewer Software Recall for Inaccurate Line Measurements

    GE Healthcare is recalling GSI Viewer software because changing the region of interest or zooming may result in inaccurate line measurements.

    Product
    GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW 4.5); 5401757
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1123-2014·2014-03-12

    AMO TECNIS CL Foldable Silicone IOLs Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 169 units of TECNIS CL Foldable Silicone IOLs because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1146-2014·2014-03-12

    Dr. Reddy's Recalls Lansoprazole Capsules Due to Microbial Contamination

    Dr. Reddy's is recalling multiple brands of Lansoprazole Delayed Release Capsules due to out-of-specification microbial counts.

    Product
    a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1095-2014·2014-03-12

    Teva Recalls Hydroxyzine Pamoate Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.

    Product
    HYDROXYZINE PAMOATE — HYDROXYZINE PAMOATE (HYDROXYZINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1091-2014·2014-03-12

    Actavis Recalls Alprazolam Extended-Release Tablets for Dissolution Failures

    Actavis Elizabeth LLC is recalling 5,148 bottles of Alprazolam Extended-Release Tablets, 3 mg, because the product failed to meet dissolution specifications.

    Product
    Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2014·2014-03-12

    Horiba Medical Recalls ABX PENTRA Calibrators Due to Updated Target Values

    Horiba Medical is recalling ABX PENTRA calibrators and controls because target values for the Creatinine Rate Blank Method were updated.

    Product
    ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1094-2014·2014-03-12

    Teva Recalls Dextroamphetamine Tablets Due to CGMP Deviations

    Teva Pharmaceuticals is recalling specific lots of Dextroamphetamine tablets because they were manufactured using unapproved material and not properly quarantined.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1097-2014·2014-03-12

    Aaron Industries Recalls Tussin CF Cold Liquid Due to Precipitate

    Aaron Industries is recalling Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid due to the presence of a white precipitate, confirmed to be the active ingredient guaifenesin.

    Product
    Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1149-2014·2014-03-12

    Medefil Recalls Heparin Syringes Due to Incorrect Barcode Labeling

    Medefil Incorporated is recalling Heparin I.V. Flush Syringes because the barcodes on the master cartons do not match the printed product codes.

    Product
    Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V121000·2014-03-11

    Winnebago Recalls Motorhomes Due to Stuck Accelerator Pedal Risk

    Winnebago is recalling 2014-2015 Travato, 2014 Trend, and 2014 Itasca Viva! motorhomes because the accelerator pedal may get stuck, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO, TREND, ITASCA VIVA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V110000·2014-03-11

    Blue Bird Recalls 2014 School Buses for Rear Wheelhousing Joint Separation

    Blue Bird is recalling 526 model year 2014 Vision and All American school buses because a rear wheelhousing joint may have separated during manufacturing, increasing injury risk in a crash.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V113000·2014-03-11

    Great Dane Recalls 2013-2015 Flatbed Trailers Due to Bracket Defect

    Great Dane is recalling 2013-2015 flatbed trailers because cargo restraint brackets may break, causing plates to fall and create road hazards.

    Product
    GREAT DANE — GREAT DANE FLATBED TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V114000·2014-03-11

    Mazda Recalls 2010-2012 Mazda6 Vehicles for Fuel Tank Fire Risk

    Mazda is recalling 2010-2012 Mazda6 vehicles because spider webs may block a fuel hose, causing tank cracks and fuel leaks that increase fire risk.

    Product
    MAZDA — MAZDA MAZDA6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V102000·2014-03-10

    Starcraft Prodigy and Quest School Buses Recalled for Door Actuator Fire Risk

    Starcraft Bus is recalling 281 model year 2009 and 2010 Prodigy and Quest school buses because voltage spikes may damage door actuator circuit boards, increasing the risk of a fire.

    Product
    STARCRAFT — STARCRAFT PRODIGY, QUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V109000·2014-03-10

    Honda Recalls 2014 Civic Vehicles for Tire Bead Damage

    Honda is recalling 2014 Civic LX vehicles because tire beads may have been pinched during assembly, potentially causing air loss and increasing crash risk.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V108000·2014-03-07

    Eldorado Transit Bus Recall for Exhaust Fire Risk

    Eldorado is recalling certain transit buses because condensation in the engine intake may freeze, causing exhaust flames that risk fire or burn injuries.

    Product
    ENC — ENC XHF, EZ-RIDER II, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·018-2014·2014-03-07

    George's Recalls Chicken Breast Strips Due to Undeclared Soy Allergen

    George's Inc. is recalling 29,200 pounds of seasoned raw chicken breast strips because the labels failed to declare soy protein and MSG.

    Product
    George's Further Processing — Arkansas Firm Recalls Chicken Products Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V111000·2014-03-07

    CM Trailers Recalls 2012 Cargo Van and Revolution Trailers for Brake Defect

    CM Trailers is recalling 2012 Cargo Van and Revolution trailers because a manufacturing defect in the hydraulic brake pump could cause a loss of braking ability.

    Product
    CM TRAILERS — CM TRAILERS CARGO VAN, REVOLUTION
    Category
    Vehicle
    Distribution
    Distributed nationwide

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