The Recall Desk

Archive

August 2013 recalls

504 recalls were announced in August 2013.

What the numbers show

Critical
20
Severe
100
High
208
Moderate
144
Low
32

Of the 504 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

1–100 of 504

  • SevereNHTSA·13V392000·2013-08-30

    Spartan Motor Home Chassis Recall for ABS Valve Fracture Risk

    Spartan is recalling 2009-2014 motor home chassis because the ABS modulator valve may fracture, increasing stopping distance or causing the vehicle to pull.

    Product
    SPARTAN — SPARTAN K2, MM, K3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V393000·2013-08-30

    Dutchmen Voltage Recalled for Generator Fuel Filter Clamp Defect

    Dutchmen is recalling 2014 Voltage recreational vehicles because the generator fuel filter clamp may be installed incorrectly. This defect could cause a fuel leak, increasing the risk of fire, injury, or property damage.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V391000·2013-08-30

    Indian Motorcycle Recalls 861 Models for Rear Rim Cracking Defect

    Indian Motorcycle is recalling 861 motorcycles from 2009-2013 because the rear rim may crack, causing a flat tire and potential loss of control.

    Product
    INDIAN — INDIAN DARK HORSE, CHIEF STANDARD, BOMBER, ROADMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V385000·2013-08-29

    Ford Recalls 2005-2011 Vehicles for Steering Column Corrosion Risk

    Ford is recalling 2005-2011 Crown Victoria, Grand Marquis, and Town Car vehicles in specific states because severe corrosion can cause steering loss.

    Product
    MERCURY — MERCURY, FORD, LINCOLN GRAND MARQUIS, CROWN VICTORIA, TOWN CAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13750·2013-08-29

    L.L.Bean Recalls Painted Cottage Step Stools Due to Fall Hazard

    L.L.Bean is recalling painted cottage step stools because they can slide or tip over, posing a fall hazard. Six incidents of slips and falls have been reported.

    Product
    Painted cottage step stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1833-2013·2013-08-28

    NuGo Slim Espresso Recalled for Undeclared Milk Allergen

    NuGo Nutrition HQ is recalling NuGo Slim Espresso Non-Dairy products because they may contain undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    NuGo Slim Espresso, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1830-2013·2013-08-28

    NuGo Dark Peanut Butter Cup Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Peanut Butter Cups labeled as non-dairy because they may contain undeclared milk.

    Product
    NuGo Dark Peanut Butter Cup, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1834-2013·2013-08-28

    Whole Foods Recalls Crave Brothers Les Freres Cheese for Listeria Risk

    Whole Foods Market is recalling Crave Brothers Les Freres cheese due to potential Listeria monocytogenes contamination, which can cause serious infections in vulnerable populations.

    Product
    Crave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut an
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1828-2013·2013-08-28

    NuGo Dark Mocha Non-Dairy Coffee Creamer Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Mocha Non-Dairy coffee creamer because it may contain undeclared milk, posing a risk to people with milk allergies.

    Product
    NuGo Dark Mocha, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1847-2013·2013-08-28

    Harmony Chai Rooibos Chai Recalled for Improper Processing

    Harmony Chai is recalling 22 oz and 64 oz bottles of decaffeinated Rooibos Chai because the product was not properly processed.

    Product
    Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai Decaffeinated Fresh brewed on Orcas Island, WA Rooibos Chai 22oz. (624,25ml)***Ingredients: water, Organic Raw Sugar, Rooibos Tea, cloves, cinnamon, Ginger, secret spices, c
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1832-2013·2013-08-28

    NuGo Slim Crunchy Peanut Butter Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Slim Crunchy Peanut Butter bars because they may contain undeclared milk, a major food allergen.

    Product
    NuGo Slim Crunchy Peanut Butter, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-915-2013·2013-08-28

    Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization

    Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.

    Product
    IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V386000·2013-08-28

    2013 Can-Am Spyder RT and ST Recalled for Brake Fire Risk

    NHTSA is recalling 2013 Can-Am Spyder RT and ST motorcycles because a brake component may melt, causing fluid leaks that increase fire risk.

    Product
    CAN-AM — CAN-AM SPYDER RT, SPYDER ST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-912-2013·2013-08-28

    Wise Woman Herbals Eyebright Eye Rinse Recalled for Sterility Concerns

    Wise Woman Herbals is recalling Eyebright Concentrate Topical Eye Rinse because it was not manufactured under sterile conditions required for ophthalmic products.

    Product
    Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1831-2013·2013-08-28

    NuGo Dark Pretzel Non-Dairy Snack Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Pretzel Non-Dairy snacks because they may contain undeclared milk, a major allergen.

    Product
    NuGo Dark Pretzel 1.59 oz (45g) Non-Dairy Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2028-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations.

    Product
    00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1976-2013·2013-08-28

    Stryker Oasys Midline Occiput Plate Recalled for Post-Operative Pin Fracture

    Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.

    Product
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V383000·2013-08-28

    Toyota Recalls RAV4 and Lexus HS 250h for Rear Suspension Defect

    Toyota is recalling 2006-2011 RAV4 and 2010 Lexus HS 250h vehicles because rear tie rods may fail, causing loss of vehicle control.

    Product
    LEXUS — LEXUS, TOYOTA HS 250 HYBRID, RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 0059
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1826-2013·2013-08-28

    NuGo Free Carrot Cake Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Free Carrot Cake bars because they may contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    NuGo Free Carrot Cake, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1827-2013·2013-08-28

    NuGo Dark Chocolate Chocolate Chip Bars Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Chocolate Chocolate Chip bars because they may contain undeclared milk, a major allergen.

    Product
    NuGo Dark Chocolate Chocolate Chip 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2042-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1982-2013·2013-08-28

    EndoGastric Solutions Recalls EsophyX2 Devices Due to Tissue Mold Control Loss

    EndoGastric Solutions is recalling EsophyX2 devices because of reports of loss of tissue mold control, which required surgical removal in one case.

    Product
    EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2018-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.

    Product
    00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Steri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1994-2013·2013-08-28

    Getinge AccuFast Biological Indicators Recalled for Potential False Negative Results

    Getinge USA is recalling AccuFast Biological Indicators, Lot SR-430, because exposure to certain conditions may cause false negative results during steam sterilization testing.

    Product
    Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biol
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2000-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer is recalling NexGen CR knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 Femur CR POROUS FEM COMP SIZE BML Rx, Sterile; 00597201202 Femur CR POROUS FEM COMP SIZE BMR Rx, Sterile; Used in total knee arthroplas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Due to Component Mismatch

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1817-2013·2013-08-28

    Pacific Pure Aid Fried Onion Powder Recalled for Gluten Mislabeling

    Pacific Pure Aid is recalling Fried Onion Powder sold as gluten-free because it contains gluten. The product was distributed in five US states and five foreign countries.

    Product
    Fried Onion Powder 44.092 lb carton
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1825-2013·2013-08-28

    NuGo Free Dark Chocolate Crunch Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Free Dark Chocolate Crunch bars because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    NuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1829-2013·2013-08-28

    NuGo Dark Mint Chocolate Chip Bars Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling Dark Mint Chocolate Chip bars because they may contain undeclared milk, posing a risk to people with milk allergies.

    Product
    NuGo Dark Mint Chocolate Chip, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, specifically mixing micro and standard parts.

    Product
    90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1812-2013·2013-08-28

    Mariposa Baking Recalls Vegan Chocolate Cupcakes Due to Unlabeled Coconut

    Mariposa Baking Co. is recalling Penguinos vegan chocolate cupcakes because a consumer found an unlabeled piece of coconut in the product.

    Product
    Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2006-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L Rx, Sterile; 00597601202 Femur CRA PRECOAT FEM COMP SIZE B/R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2013·2013-08-28

    Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2007-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations. The issue persists despite a previous 2012 recall.

    Product
    00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2013·2013-08-28

    Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts

    Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.

    Product
    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1986-2013·2013-08-28

    Medtronic MiniMed Paradigm Reservoirs Recalled for Potential Leaking Risk

    Medtronic is recalling specific lots of Paradigm insulin reservoirs because they may leak, potentially delivering less insulin than intended.

    Product
    Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2027-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR knee implant components because surgeons are using them in unapproved combinations. The recall covers 192,355 devices distributed in the US and Japan.

    Product
    90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597101101 Provisional CR PROV FRM COMP SIZE AML, Rx, Sterile; 00597101102 Provisional CR PROV FRM COMP SIZE AMR, Rx, Sterile; 00597101201 Provisional CR PROV FRM COMP SIZE BML, Rx, Sterile; 00597101202 Provisional CR PROV FRM COMP SIZE BMR, Rx, Sterile; 00597101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2013·2013-08-28

    GE Healthcare Precision 500D X-Ray Systems Recalled for Monitor Suspension Defect

    GE Healthcare is recalling Precision 500D systems because a locking nut on the overhead video monitor suspension may loosen, posing a risk of impact.

    Product
    GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2013·2013-08-28

    Invacare Recalls CHAMPION Medical Recliners Due to Heat and Labeling Issues

    Invacare is recalling 285 CHAMPION Medical Recliners because the seat pad may reach elevated temperatures and the cord set labeling is incorrect.

    Product
    CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2005-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2013·2013-08-28

    Medicel nanoPOINT Injector System Recalled for Potential Sterility Compromise

    Medicel Ag is recalling one lot of nanoPOINT Injector Systems because damaged Tyvek lids may have compromised the sterile barrier.

    Product
    Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, mixing micro and standard parts.

    Product
    00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in tot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2013·2013-08-28

    Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

    Zimmer is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF 56/STRI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2035-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer is recalling NexGen CR knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533 Femu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1824-2013·2013-08-28

    NuGo Free Dark Chocolate Trail Mix Bar Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling specific lots of Free Dark Chocolate Trail Mix Bars because they may contain undeclared milk.

    Product
    NuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations with standard parts.

    Product
    00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13272·2013-08-28

    Baby Jogger Recalls Car Seat Adaptors for Strollers Due to Fall Hazard

    Baby Jogger is recalling car seat adaptors for strollers because the support bars can fail, causing the car seat to fall and posing a risk of injury to infants.

    Product
    Car Seat Adaptor for Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are implanting them in unapproved combinations.

    Product
    90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9, Rx, Sterile; 00597204110 Articular Surface CR ART SURF 56/STRIPE GRN 10, Rx, Sterile; 00597204112 Articular Surface CR ART SURF 56/STRIPE GRN 12, Rx, Sterile; 00597204114 Articular Surface CR ART SURF 56/STRIPE G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2021-2013·2013-08-28

    Zimmer NexGen Knee System Recall for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile; 0059
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1848-2013·2013-08-28

    SensoryEffects Recalls Maple Flavored Lipid-Based Inclusions Due to Salmonella

    SensoryEffects Powder Systems is recalling specific lots of maple flavored lipid-based inclusions after a sample tested positive for Salmonella.

    Product
    Maple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel), wheat flour, cocoa powder, glucose, extractives of foenugreek, maple sugar, caramel color, soy lecithin. SensoryEffects¿¿ , 136 Fox Run Dr.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2011-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2022-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00595203110 Articular Surface XLPE CR ART SURF 3,4/SYEL 10, Rx, Sterile; 00595203112 Articular Surface XLPE CR ART SURF 3,4/SYEL 12, Rx, Sterile; 00595203114 Articular Surface XLPE CR ART SURF 3,4/SYEL 14, Rx, Sterile; 00595203117 Articular Surface XLPE CR ART SURF 3,4/S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597504110 Provisional AC ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597504112 Provisional AC ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597504114 Provisional AC ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597504117 Provisional AC ART SURF PROV 56/STR GRN 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2013·2013-08-28

    GE Healthcare Recalls Discovery NM/CT 570c Systems for Scanning Error

    GE Healthcare is recalling 10 Discovery NM/CT 570c systems in Connecticut after an incident where the wrong part of a patient's body was scanned during a CT exam.

    Product
    The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1988-2013·2013-08-28

    Aspen Surgical Recalls Wound Closures Due to Sterility Concerns

    Aspen Surgical Products is recalling reinforced wound closure strips because FDA sampling indicated the product may not be sterile, posing a risk of infection.

    Product
    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2013·2013-08-28

    Blue Belt Technologies Recalls Sterile Monitor Drapes for Navio PFS System

    Blue Belt Technologies is recalling sterile monitor drapes used with the Navio PFS system during orthopedic knee surgery because the front section separates from the rest of the drape.

    Product
    Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen Knee System components because surgeons are implanting them in unapproved combinations, creating a risk of improper fit.

    Product
    00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2013·2013-08-28

    Stryker Visum 300 Ceiling-mounted Exam Light Recalled for Weld Defect

    Stryker Communications is recalling 1,375 Visum 300 Ceiling-mounted Exam Lights due to a potential incomplete final weld on the drop tube flange.

    Product
    Stryker Visum 300 Ceiling-mounted Exam Light.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1818-2013·2013-08-28

    Pacific Pure Aid Thai Chili Flake Recalled for Gluten Mislabeling

    Pacific Pure Aid is recalling Thai Chili Flake sold as gluten-free because it contains gluten. The product was distributed in several US states and foreign countries.

    Product
    Thai Chili Flake
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1983-2013·2013-08-28

    Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure

    Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.

    Product
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the elec
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1839-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 26/30 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-913-2013·2013-08-28

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity and degradation specifications. The affected product is distributed nationwide.

    Product
    Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-898-2013·2013-08-28

    Stayma Recalls Duet DHA 430 Vitamins for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 430 vitamin and Omega-3 products because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1845-2013·2013-08-28

    Green Core Recalls Okami Lobster Rolls Due to Raw Meat Misbranding

    Green Core is recalling Okami Fully Cooked Wild-Caught Lobster Rolls because raw lobster meat was used instead of cooked meat.

    Product
    Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1843-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1846-2013·2013-08-28

    Harmony Chai Acidified Tea Recalled for Improper Processing

    Harmony Chai is recalling Black Spiced Chai tea in 22 oz and 64 oz glass bottles because the product was not properly processed.

    Product
    Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, c
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1814-2013·2013-08-28

    Evviva Peach Spumante Recalled for Unpermitted Coloring Ingredients

    Johnson Brothers Liquor Company is recalling Evviva Fresh Peach Spumante because it contains coloring ingredients not permitted for use in the United States.

    Product
    Evviva Fresh Peach Spumante, UPC 84279-99137
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-894-2013·2013-08-28

    Duet DHA Balanced Recalled for Subpotent Beta Carotene Content

    Stayma Consulting Service is recalling Duet DHA Balanced tablets and softgels because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Ma
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1815-2013·2013-08-28

    Evviva Spumante Recalled for Unpermitted Coloring Ingredients in US

    Johnson Brothers Liquor Company is recalling Evviva Strawberry and Peach Spumante because they contain coloring ingredients not permitted for use in the United States.

    Product
    Evviva Strawberry Spumante, UPC 84279-99138
    Category
    Food
    Distribution
    12 states

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