The Recall Desk

Archive

May 2014 recalls

394 recalls were announced in May 2014.

What the numbers show

Critical
29
Severe
101
High
158
Moderate
89
Low
17

Of the 394 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

101–200 of 394

  • SevereNHTSA·14V276000·2014-05-23

    Van Hool C2045 Coaches Recalled for Electrical Fire Risk

    Van Hool is recalling 2004, 2006, and 2013 C2045 coaches because a battery equalizer component may conduct electricity when heated, increasing fire risk.

    Product
    VAN HOOL — VAN HOOL C2045
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V278000·2014-05-23

    Suzuki Recalls 2014 DL650A V-Strom Motorcycles for Drive Chain Defect

    Suzuki is recalling 103 model year 2014 DL650A V-Strom motorcycles because a drive chain link may not have been riveted, which could cause the chain to come off and increase crash risk.

    Product
    SUZUKI — SUZUKI DL650A V-STROM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V270000·2014-05-22

    Lexus Recalls 2013 GS 350 for Brake Pedal Switch Failure

    Toyota is recalling 2013 Lexus GS 350 vehicles because a brake pedal switch may fail, causing the vehicle to brake without driver input and increasing crash risk.

    Product
    LEXUS — LEXUS GS 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14188·2014-05-22

    Office Depot Recalls Gibson Leather Task Chairs Due to Fall Hazard

    Office Depot is recalling Gibson Leather Task Chairs because the seat plate weld can break, posing a fall hazard. About 1.4 million chairs were sold.

    Product
    Office Depot® Gibson Leather Task Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V271000·2014-05-22

    Tiffin Recalls 2008-2011 RVs for LED Clearance Light Fire Risk

    Tiffin Motorhomes is recalling specific 2008-2011 recreational vehicles because moisture in LED clearance lights may cause a short circuit, increasing the risk of a fire.

    Product
    TIFFIN — TIFFIN BUS, BREEZE, ZEPHYR, ALLEGRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V273000·2014-05-22

    Toyota Recalls 2004-2011 Siennas for Corroded Spare Tire Carrier Cable

    Toyota is recalling 2004-2011 Siennas in specific states because the spare tire carrier cable may corrode from road salt, risking the tire falling off and causing a crash.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V275000·2014-05-22

    Great Dane Recalls 2015 Dry Freight Semi-Trailers for Missing Weld

    Great Dane is recalling 2015 Dry Freight Semi-Trailers because a missing weld could cause trailer separation and increase crash risk.

    Product
    GREAT DANE — GREAT DANE DRY FREIGHT SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V272000·2014-05-22

    Toyota Recalls 2014 Highlanders Due to Air Bag Software Error

    Toyota is recalling 2014 Highlander and Highlander Hybrid vehicles because improper air bag software may fail to properly restrain larger front passengers in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER HYBRID, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V274000·2014-05-22

    Toyota Recalls 2014 Highlanders Due to Second Row Seat Locking Defect

    Toyota is recalling 231 model year 2014 Highlanders because the second row right-hand seat may not fully lock into the track, increasing injury risk in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14189·2014-05-22

    Lakeshore Bristle Builders for Toddlers Recalled Due to Choking Hazard

    Lakeshore Learning Materials is recalling Bristle Builders for Toddlers play sets because animal figure bases can detach, posing a choking hazard to young children.

    Product
    Lakeshore Bristle Builders® for Toddlers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1932-2014·2014-05-21

    Fresh Express Italian Salad Recalled for Listeria Contamination

    Chiquita Brands International is recalling Fresh Express Italian salad due to Listeria monocytogenes contamination. The product was distributed in 15 states and DC.

    Product
    Fresh Express, Italian, Crunchy Romaine Lettuce and Red Cabbage Salad, 10oz clear plastic bags, UPC: 71279-21100.
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Drugs)·D-1322-2014·2014-05-21

    REUMOFAN PLUS Tablets Recalled for Undeclared Ingredients and Lack of Approval

    Pain Free By Nature is recalling REUMOFAN PLUS tablets because they were marketed without FDA approval and contain undeclared diclofenac and methocarbamol.

    Product
    REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1948-2014·2014-05-21

    Purity Organic Fresh Mangoes Recalled for Listeria Monocytogenes

    Pacific Organic Produce is recalling Purity Organic Fresh Mangoes after an inspection sample tested positive for Listeria monocytogenes.

    Product
    Purity Organic - Organic Mango Mango Tommy Atkins CAT 1, Size 07, 08, 10 and 12. Product of Mexico, Pacific.com distributed by: Pacific Organic Produce, San Francisco, CA 94080
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1929-2014·2014-05-21

    Fernandez Chile Molido Puro Recalled for Salmonella Contamination

    Fernandez Chile Company is recalling specific lots of chile products due to Salmonella contamination. Consumers in Colorado and New Mexico should check their pantries.

    Product
    Fernandez True Chile Flavor, Medium Hot Chile Molido Puro, 4 oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1318-2014·2014-05-21

    FDA Recalls Unapproved Saluta Reduced Glutathione Injection Powder

    Flawless Beauty LLC is recalling Saluta (reduced glutathione) Powder for Injection because it was marketed without an approved NDA/ANDA and is labeled for use as an antidote.

    Product
    Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 10 vials per box, Exclusively Distributed by: QAF Pharmaceuticals Inc. Philippines, Unit Unit 202 ECG Building, Multinational Avenue, Multinational Village, Parahaque City, Metro Manila Philippines; Manuf
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1319-2014·2014-05-21

    Flawless Beauty LLC Recalls Unapproved Injectable Glutathione Solution

    Flawless Beauty LLC is recalling Relumins Advanced Glutathione injectable solution because it was marketed without an approved NDA or ANDA.

    Product
    Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable solution, 1500 mg/500 mg, packaged in 8-count vials, 8-count 5 mL vitamin C (ascorbic acid) solution diluent ampoules, and 30-count Advanced Glutathione Boosters capsules per box, Relumins Labs, 183 Locu
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·031-2014·2014-05-21

    Prime Pak Foods Recalls Breaded Chicken Products Due to Undeclared Allergens

    Prime Pak Foods is recalling approximately 23,250 pounds of fully cooked breaded chicken products because they contain undeclared eggs, milk, and wheat.

    Product
    Gold Creek Foods LLC — Georgia Firm Recalls Chicken Breast and Tender Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1930-2014·2014-05-21

    Fernandez Chile Products Recalled Due to Salmonella Contamination

    Fernandez Chile Company is recalling specific chile products due to Salmonella contamination. Consumers in Colorado and New Mexico should check their pantries.

    Product
    Fernandez True Chile Flavor, Mild Chile Rojo, 6 oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1931-2014·2014-05-21

    Frozen Pasta Meal Recalled for Undeclared Pinenut Allergen

    Dd Foodsolutions Inc. is recalling frozen corkscrew pasta meals due to undeclared pinenuts, a potential allergen.

    Product
    Frozen Corkscrew Pasta and Creamy tomato Vodka Sauce meal, Net Wt 9oz
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1619-2014·2014-05-21

    Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure

    Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.

    Product
    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1935-2014·2014-05-21

    Raw Deal Recalls Organic Parsley Powder for Potential Salmonella Contamination

    Raw Deal is recalling organic parsley powder that may contain salmonella. The product was distributed in Connecticut, Utah, and Canada.

    Product
    Parsley Powder Organic 25 KGS PO# GV93-6 & PO#RV19-4 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1937-2014·2014-05-21

    Good Taste Plum Recalled for Undeclared Sulfites and Unapproved Color

    Mandy Star Trading Inc. is recalling Good Taste brand Plum due to undeclared sulfites, undeclared FD&C Yellow #6, and unapproved color Ponceau 4R.

    Product
    GOOD TASTE brand Plum, 10.5 OZ, PRODUCT OF CHINA, UPC 3 867320 507650 --- AMERICA MANDY STAR TRADING
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1933-2014·2014-05-21

    Raw Deal Recalls Adult Herbal Blend 992 Due to Salmonella Risk

    Raw Deal is recalling Adult Herbal Blend 992 because it may contain salmonella. The product was distributed in Connecticut, Utah, and Canada.

    Product
    Adult Herbal Blend 992 Item #H039 30 KGS PO#33590 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1317-2014·2014-05-21

    Flawless Beauty Recalls Tatiomax Injection Vials Sold Without FDA Approval

    Flawless Beauty LLC is recalling Tatiomax powder for injection vials because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

    Product
    Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1934-2014·2014-05-21

    Raw Deal Recalls Cilantro Powder for Potential Salmonella Contamination

    Raw Deal is recalling 45 kg of Cilantro Powder that may contain salmonella. The product was distributed to Connecticut, Utah, and Canada.

    Product
    Cilantro Powder Item #13151 22.5 KGS PO #P41049 Raw Deal Inc. PO Box 412 Allamuchy, NJ 07820 Phone: 973-347-6400 Fax: 973-347-5999 www.raw-deal.net
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1320-2014·2014-05-21

    Flawless Beauty Recalls Vitamin C Injection Sold Without FDA Approval

    Flawless Beauty LLC is recalling Vitamin C Injection ampoules marketed without an approved NDA/ANDA. The product is sold over the counter with labeling indicating disease treatment.

    Product
    Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules per box, Manufactured by: TP Drug Laboratories (1969) Co., Ltd., 98 Soi Sukhumvlt 62, Yak 1, Bangchak, Prakanong, Bangkok 10260, Thailand, Reg. No. 1 A 1557/30; UPC 8 853533 000533
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1321-2014·2014-05-21

    Flawless Beauty Recalls Sterile Water for Injection Sold Without Approval

    Flawless Beauty LLC is recalling Sterile Water for Injection ampoules sold over the counter without an approved NDA or ANDA.

    Product
    Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per box, Manufactured and Distributed by: Euro Med Laboratories, UPC 4800573016219
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2014·2014-05-21

    Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination

    Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.

    Product
    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2014·2014-05-21

    Zimmer Cartilage Knee Brace Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.

    Product
    Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2014·2014-05-21

    InterValve V8 Balloon Aortic Valvuloplasty Catheter Recalled for Leak Issues

    InterValve Inc is recalling specific V8 Balloon Aortic Valvuloplasty Catheters due to leak issues discovered during accelerated age testing.

    Product
    InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1609-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.

    Product
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1613-2014·2014-05-21

    Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error

    Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.

    Product
    Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2014·2014-05-21

    Baxter Recalls RAPIDFILL Syringe Strips Due to Sterile Barrier Breach

    Baxter Corporation is recalling RAPIDFILL Syringe Strips because of a possible breach in the sterile barrier of the inner and outer bags.

    Product
    RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Stri
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1603-2014·2014-05-21

    Zimmer Drop Lok Knee Brace Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling Drop Lok Knee Braces because raw material labeled as latex-free was found to contain latex. The recall affects 131 units distributed in the US and internationally.

    Product
    DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1575-2014·2014-05-21

    Blue Belt Technologies Recalls Navio PFS Orthopedic Sterotaxic Instrument

    Blue Belt Technologies is voluntarily recalling 11 Navio PFS systems used in orthopedic knee surgery due to a potential electronic module defect that could cause latent failure.

    Product
    NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1573-2014·2014-05-21

    SCC Soft Computer Recalls SoftMic Laboratory Information System Software

    SCC Soft Computer is recalling SoftMic version 4.0.7.0 because missing SNOMED codes may cause incomplete patient data and delayed treatment updates.

    Product
    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1567-2014·2014-05-21

    CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue

    CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.

    Product
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids usi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14187·2014-05-21

    Nest Labs Recalls Nest Protect Smoke and Carbon Monoxide Alarms

    Nest Labs is recalling Nest Protect Smoke + CO alarms because the Nest Wave feature can prevent the alarm from sounding during a fire. No injuries or property damage have been reported.

    Product
    Nest Protect: Smoke + CO Alarm
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1615-2014·2014-05-21

    Biomet ExploR Radial Stem Recalled for Missing Threads

    Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.

    Product
    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1936-2014·2014-05-21

    Swanson Cilantro Supplement Recalled for Potential Salmonella Contamination

    Swanson Health Products is recalling specific lots of Full Spectrum Cilantro herbal supplements due to a potential risk of salmonella contamination.

    Product
    Swanson Full Spectrum Cilantro (Coriander) Herbal Supplement, 60 capsules, 425 mg, SW1112. UPC 87614-11112
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1941-2014·2014-05-21

    Kroger Private Selection Ice Cream Recalled for Undeclared Egg Allergen

    Kroger is recalling Private Selection Chocolate Hazelnut Mascarpone Ice Cream because the label failed to declare eggs in the ingredient statement.

    Product
    Private Selection Chocolate Hazelnut Mascarpone Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CHOCOLATE HAZELNUT MASCARPONE ICE CREAM chocolate covered hazelnuts folded into creamy mascarpone ice cream***INGREDIENTS: ICE CREAM MILK, CREAM SUG
    Category
    Food
    Distribution
    31 states
  • HighFDA (Food)·F-1947-2014·2014-05-21

    Deb-El Foods Recalls Dried Whole Eggs for Undeclared Milk

    Deb-El Food Products LLC is recalling dried whole eggs due to undeclared milk. The affected product was distributed in Mexico, Canada, and Denmark.

    Product
    Deb-El Foods Dried Whole Eggs Deb El Food Products LLC 2 Papetti Plaza, Elizabeth, NJ 07206
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1566-2014·2014-05-21

    Baxter ABACUS TPN Calculation Software Recalled for Calculation Errors

    Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.

    Product
    ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2014·2014-05-21

    Medline Mucus Specimen Traps Recalled for Potential Sterility Issues

    Medline Industries is recalling 1,610 mucus specimen traps because they may not be sterile, which could contaminate patient specimens.

    Product
    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2014·2014-05-21

    HeartWare HVAD Pump Implant Kit Battery Recall for Support Issues

    HeartWare Inc is recalling HVAD Pump Implant Kit batteries that may not provide two hours of support or behave unusually.

    Product
    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and o
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1605-2014·2014-05-21

    Zimmer Hinged Knee Support Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.

    Product
    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1938-2014·2014-05-21

    Fong Kee Tofu Soy Bean Cake Recalled for Undeclared Wheat Allergen

    Fong Kee Tofu Co., Inc. is recalling Soy Bean Cake products because they contain wheat, a sub-ingredient of soy sauce, that is not declared on the label.

    Product
    Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fong Kee Tofu Inc. 1135 Revere Ave. San Francisco, CA 94124.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1616-2014·2014-05-21

    Roche Recalls ACCU-CHEK Compact Plus Test Strips Due to Ceftriaxone Interference

    Roche is recalling ACCU-CHEK Compact Plus test strips because they may produce erroneously low blood glucose readings in patients taking Ceftriaxone.

    Product
    ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2014·2014-05-21

    Fresenius Hemodialysis Machines Recalled for Potential UF Pump Detection Failure

    Fresenius Medical Care is recalling 79 hemodialysis machines and replacement parts because they may fail to detect a disconnected Ultrafiltration (UF) Pump.

    Product
    Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190234 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2014·2014-05-21

    Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure

    Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.

    Product
    Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or
    Category
    Medical Device
    Distribution
    16 states
  • HighNHTSA·14V268000·2014-05-21

    Stoughton Trailers Recall 2014 Models for Suspension Pivot Bolt Failure

    Stoughton is recalling 879 specific 2014 trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    STOUGHTON — STOUGHTON AHV, AVW, ZGPVW, AVXW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V269000·2014-05-21

    Eldorado Aerotech 240 Recalled for Wheelchair Lift Cable Fire Risk

    Eldorado is recalling 2012-2014 Aerotech 240 vehicles because a wheelchair lift cable may not clear the lift, potentially causing a short circuit and fire.

    Product
    ELDORADO — ELDORADO AEROTECH 240
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1940-2014·2014-05-21

    Trader Giotto's Caesar Salad Recalled for Missing Allergen Labeling

    H Group is recalling Trader Giotto's Caesar Salad because the packaging may fail to list wheat, soy, egg, and fish allergens.

    Product
    TRADER GIOTTO'S CAESAR SALAD with Caesar Dressing, NET WT. 8/5 OZ (241g).
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1945-2014·2014-05-21

    Hickory Farms Chipotle Ranch Sauce Recalled for Unlabeled Milk Allergen

    Woeber Mustard Manufacturing Co Inc is recalling Hickory Farms Chipotle Ranch Sauce because it contains an unlabeled milk allergen.

    Product
    Hickory Farms Chipotle Ranch Sauce; 9 oz. clear plastic pinch waist bottle
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1942-2014·2014-05-21

    Kroger Ice Cream Recalled for Undeclared Egg Allergen

    Kroger is recalling Private Selection Caramel Hazelnut Fudge Truffle Ice Cream because the label failed to declare eggs in the ingredient statement.

    Product
    Private Selection Caramel Hazelnut Fudge Truffle Ice Cream, 16 fl oz lamented carton. Product labeled in part, "PRIVATE SELECTION" CARAMEL HAZELNUT FUDGE TRUFFLE ICE CREAM caramel, hazelnuts and fudge truffles folded into chocolate ganache ice cream***INGREDIENTS: ICE CREAM - MI
    Category
    Food
    Distribution
    31 states
  • ModerateFDA (Food)·F-1944-2014·2014-05-21

    Kaija Ivasi Herring Fillets Recalled for Salt Standard Violation

    Zip International Group LLC is recalling Kaija Ivasi Lightly Salted Herring Fillets in Oil because the product does not meet the required water phase salt standard for processed fish.

    Product
    Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1617-2014·2014-05-21

    McKesson Radiology-PACS software recall for missing high-priority alert icon

    McKesson Medical Imaging is recalling 45 units of McKesson Radiology-PACS software because the high-priority alert icon was not displayed when no Stat studies were present.

    Product
    McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1323-2014·2014-05-21

    First Aid Only Recalls Ibuprofen Dispenser Boxes Containing Aspirin

    First Aid Only is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes that were accidentally filled with aspirin packs.

    Product
    Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes (Item Number FAE 7014), 20 count boxes, First Aid Only Inc., Vancouver, WA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D1292-2014·2014-05-21

    Teva Recalls Methyldopa Tablets Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is recalling Methyldopa Tablets USP, 500 mg, due to CGMP deviations and laboratory testing not following GMP requirements.

    Product
    METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1293-2014·2014-05-21

    Teva Recalls Glyburide and Metformin Tablets Due to GMP Deviations

    Teva Pharmaceuticals USA is recalling specific bottles of Glyburide and Metformin Hydrochloride tablets due to laboratory testing deviations from GMP requirements.

    Product
    GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1294-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling 7,694 bottles of Indomethacin Capsules USP, 25 mg, due to CGMP deviations and laboratory testing failures.

    Product
    INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1295-2014·2014-05-21

    Teva Recalls Indomethacin Capsules Due to Manufacturing Quality Deviations

    Teva Pharmaceuticals USA is recalling Indomethacin Capsules USP, 50 mg, because laboratory testing was not conducted in accordance with Good Manufacturing Practice (GMP) requirements.

    Product
    INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1316-2014·2014-05-21

    Flawless Beauty LLC Recalls Laroscorbine Platinium Injectable Solution

    Flawless Beauty LLC is recalling Laroscorbine Platinium injectable solution because it was marketed without an approved NDA/ANDA and includes drug claims to act as an antidote.

    Product
    Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-S
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1611-2014·2014-05-21

    Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature

    Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.

    Product
    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2014·2014-05-21

    Greatbatch Recalls Coaxial Micro-Introducer Kits Due to Shelf Life Documentation Issues

    Greatbatch Medical is recalling Coaxial Micro-Introducer Kits because documentation does not support the claimed five-year shelf life.

    Product
    Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 Pack 4FR Bard 10636-008 8005012 Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2014·2014-05-21

    FDA Recalls Unapproved Enaly 1000 BT-12 Ozone Generator for Medical Use

    William C. Domb, D.M.D., A Professional Corporation is recalling 16 units of the Enaly 1000 BT-12 Ozone Generator because the device is not approved or cleared by the FDA for medical use.

    Product
    Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour from pure oxygen. The 1000BT-12 ozone generator is designed to continuously generate ozone by corona discharge. The conversion of oxygen to
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1574-2014·2014-05-21

    Anspach Cutting Bur Recall Due to Incorrect Product Code Labeling

    The Anspach Effort, Inc. is recalling 30 Anspach Cutting Burs (REF L-3SD) because the product code S-3SD was included, which is shorter than the labeled product.

    Product
    ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 90 MedStream Programmable Infusion Pumps because a small number may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1572-2014·2014-05-21

    Codman MedStream Infusion Pump Recall for Low Battery Alarm Issue

    Codman & Shurtleff is recalling 34 MedStream Programmable Infusion Pumps because they may trigger a low battery alarm at the beginning of the implanted life.

    Product
    MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1610-2014·2014-05-21

    Ortho Development Recalls PS-C Femoral Knee Implant Components

    Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.

    Product
    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1943-2014·2014-05-21

    Gold Medal Recalls Cajun Savory Packed in Hot & Spicy Containers

    Gold Medal Products is recalling 137 containers of Cajun Savory that were packed in Hot & Spicy containers. The recall covers distribution in nine US states and Bermuda.

    Product
    2372 HOT & SPICY; 4 pound plastic gallon containers; UPC 0 9093912372 7
    Category
    Food
    Distribution
    9 states
  • LowFDA (Drugs)·D-1315-2014·2014-05-21

    Konsyl Psyllium Fiber Recalled for Inaccurate Labeling of Active Ingredient Strength

    Konsyl Pharmaceuticals is recalling 6,286 bottles of Psyllium Fiber capsules because the label lists an inaccurate strength for the active ingredient.

    Product
    PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.
    Category
    Drug
    Distribution
    9 states
  • CriticalCPSC·14185·2014-05-20

    Bed Handles Inc. Recalls Portable Bed Handles Due to Entrapment Deaths

    Bed Handles Inc. is recalling about 113,000 portable bed handles sold without safety retention straps. Three deaths were reported after users became entrapped between the mattress and the shifting handles.

    Product
    Portable bed handles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V267000·2014-05-20

    Thor Motor Coach Recalls Outlaw 29H Motorcoaches Due to Fire Risk

    Thor Motor Coach is recalling 2014-2015 Outlaw 29H motorcoaches because the generator exhaust is too close to the propane tank and may release carbon monoxide.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V265000·2014-05-20

    GM Recalls 2015 Silverado HD and Sierra HD for Fire Risk

    General Motors is recalling 2015 Chevrolet Silverado HD and GMC Sierra HD trucks because loose fuse block clips can cause a short circuit and engine compartment fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO HD, SIERRA HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V266000·2014-05-20

    GM Recalls 2009-2014 SUVs for Seatbelt Cable Defect

    General Motors is recalling specific 2009-2014 Buick, Chevrolet, GMC, and Saturn SUVs because a seatbelt cable may separate, increasing injury risk in a crash.

    Product
    BUICK — BUICK, GMC, SATURN ENCLAVE, ACADIA, OUTLOOK, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E026000·2014-05-19

    Agility Fuel Systems Recalls CNG Tank Rail Mount Systems

    Agility Fuel Systems is recalling CNG Tank Rail Mount Systems manufactured between September 2010 and January 2013. The defect may allow the tank to move, potentially damaging fuel lines and increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY:MOUNTING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V262000·2014-05-19

    Suzuki Recalls Forenza and Reno Vehicles for Headlamp Fire Risk

    Suzuki is recalling 2004-2008 Forenza and 2005-2008 Reno vehicles because heat in the headlamp switch or DRL module could melt components and cause a fire.

    Product
    SUZUKI — SUZUKI FORENZA, RENO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E025000·2014-05-19

    Agility Fuel Systems Recalls CNG Fuel Tank Systems for Valve Defect

    Agility Fuel Systems is recalling CNG Fuel Tank Systems where the manual shutoff valve may get stuck closed, posing a safety risk to service personnel.

    Product
    FUEL SYSTEM, OTHER:STORAGE:TANK ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·030-2014·2014-05-19

    Wolverine Packing Recalls Ground Beef Due To Possible E. Coli O157:H7

    Wolverine Packing Company is recalling approximately 1.8 million pounds of ground beef products due to possible E. coli O157:H7 contamination.

    Product
    Wolverine Packing Co. — Michigan Firm Recalls Ground Beef Products Due To Possible E. Coli O157:H7
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V258000·2014-05-16

    Honda Recalls 2013 Fit Vehicles for Driveshaft Breakage Risk

    Honda is recalling 2013 Fit vehicles with manual transmissions because the passenger side driveshaft may break, potentially causing loss of power or unexpected movement.

    Product
    HONDA — HONDA FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V263000·2014-05-16

    Nissan Recalls 2014 LEAF Vehicles Due to Inverter Failure Risk

    Nissan is recalling 2014 LEAF vehicles because a motor control circuit board defect may cause the inverter to fail, leading to an unexpected vehicle shut down.

    Product
    NISSAN — NISSAN LEAF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·028-2014·2014-05-16

    Transatlantic Foods Recalls Pork and Poultry Products Due to Lack of Inspection

    Transatlantic Foods is recalling approximately 222,000 pounds of pork and poultry products because they were produced without the required USDA inspection.

    Product
    New York Firm Recalls Pork and Poultry Products Due To Lack of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14E023000·2014-05-16

    Harley-Davidson Recalls 2014 XL Sportster Brake Lever Kits

    Harley-Davidson is recalling accessory brake lever kits for 2014 XL Sportster motorcycles because excess chrome plating may prevent the front brake from releasing, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XL SPORTSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V259000·2014-05-16

    GM Recalls 2015 Cadillac Escalade Models for Air Bag Defect

    General Motors is recalling 2,838 2015 Cadillac Escalade and Escalade ESV vehicles because the front passenger air bag may only partially deploy in a crash.

    Product
    CADILLAC — CADILLAC ESCALADE, ESCALADE ESV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·029-2014·2014-05-16

    Transatlantic Foods Recalls Pork Products Due to Misbranding

    Transatlantic Foods is recalling 449,000 pounds of pork products because labels falsely claimed the items contained no antibiotics.

    Product
    Recall Notification Report 029-2014 (Pork Products)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·14184·2014-05-15

    Exmark Recalls Quest ZRT Riding Mowers Due to Steering Failure

    Exmark is recalling 2009 and 2010 Quest ZRT riding mowers because the steering assembly can fail, causing loss of control and crash hazards.

    Product
    Exmark Quest ZRT Riding Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·14179·2014-05-15

    Gree Recalls Dehumidifiers Due to Fire and Burn Hazards

    Gree is recalling approximately 2.5 million dehumidifiers in the U.S. and 55,000 in Canada due to fire and burn hazards. Consumers should unplug the units and contact Gree for a refund.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14183·2014-05-15

    BMC Recalls Three Bicycle Models Due to Fork Breakage Hazard

    BMC is recalling approximately 160 Alpenchallenge, Masschallenge, and Urbanchallenge bicycles because the carbon forks can crack or break, posing a fall hazard.

    Product
    BMC Alpenchallenge, Masschallenge and Urbanchallenge Bicycles with Aprebic Forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14182·2014-05-15

    StyleCraft Recalls Upholstered Benches Due to Fall Hazard

    StyleCraft is recalling upholstered benches sold at HomeGoods because they can crack and break, posing a fall hazard. No injuries have been reported.

    Product
    Upholstered Benches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14180·2014-05-15

    H&M Recalls Girls' Leggings Due to Choking Hazard

    H&M is recalling approximately 65,000 girls' leggings because a metal part on the belt can detach, posing a choking hazard to young children.

    Product
    Girls' Leggings
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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