The Recall Desk

Archive

July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical
104
Severe
251
High
252
Moderate
109
Low
25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 34% are Severe.

401–500 of 741

  • HighFDA (Devices)·Z-1680-2013·2013-07-17

    ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect

    ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.

    Product
    ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw creates a potential for anterior impingement between bone and the poly bearing.

    Product
    REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing ti
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1710-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 29 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1708-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1721-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1627-2013·2013-07-17

    Eco-Cuisine Scone Mix Recalled for Potential Salmonella Contamination

    Eco-Cuisine is recalling Basic English Scone Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Basic English Scone Mix, SKU: CM25SCONE, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1720-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1590-2013·2013-07-17

    Mother Earth Veggie Burger Recalled for Potential Salmonella Contamination

    Mother Earth International LLC is recalling Veggie Burger Textured Vegetable Protein products due to potential Salmonella contamination from a soy protein isolate ingredient.

    Product
    Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1621-2013·2013-07-17

    Eco-Cuisine Chocolate Brownie Mix Recalled for Salmonella Contamination Risk

    Eco-Cuisine is recalling Chocolate Brownie Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Chocolate Brownie Mix, SKU: AA01BRWN, Pack size 1 lb bag, 10 bags per case, and SKU: AA25BRWN 25 lbs bulk bag, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1631-2013·2013-07-17

    Eco-Cuisine Recalls Chicken Style Quick Mix Due to Salmonella Risk

    Eco-Cuisine is recalling specific lots of Chicken Style Quick Mix because of potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine "Chicken Style" Quick Mix, SKU: RM10CKQM, Pack size 10 lb bag, Distributed by Eco-Cuisine and manufactured by Rocy Mountain Spice, and SKU: TV10CKQM, package size 10 lb bag, distributed by Eco-Cuisine and manufactured by TOVA.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1639-2013·2013-07-17

    CHS Inc Recalls Solcon Soy Protein Concentrates for Salmonella Risk

    CHS Inc is recalling specific Solcon Soy Protein Concentrates produced in Israel due to potential Salmonella contamination. The product was distributed internationally and did not enter the U.S. market.

    Product
    Solcon Soy Protein Concentrates. Item No. / Item Description: 12110 / Solcon F GMO, 3112030 / Solcon F Soy Protein Concentrate, 12100 / Solcon GMO, and 3112002 / Solcon GMO Soy Protein Concentrate
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1622-2013·2013-07-17

    Eco-Cuisine Recalls Reduced Sodium Ground Beef Style Quick Mix for Salmonella Risk

    Eco-Cuisine is recalling specific lots of Reduced Sodium "Ground Beef Style" Quick Mix due to potential Salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Reduced Sodium "Ground Beef Style" Quick Mix, SKU: AA10GBQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO; and TV10GBQM 10 lb bag distributed by Eco-Cuisine and manufactured by TOVA, Louisvill
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1646-2013·2013-07-17

    Archer Farms Smoked Salmon Dip Recalled for Undeclared Fish and Egg Allergens

    Garden Fresh Foods is recalling Archer Farms Smoked Salmon Dip because some packages may contain undeclared fish and egg allergens.

    Product
    LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1602-2013·2013-07-17

    Salmolux Recalls Norwegian Smoked Salmon Due to Listeria Risk

    Salmolux is recalling Norwegian Smoked Salmon (Nova Lox) due to potential Listeria monocytogenes contamination. The product was distributed in ten states.

    Product
    "***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44328 0***".
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1640-2013·2013-07-17

    Chs Inc Recalls Solcon S Soy Protein Concentrates Due to Salmonella Risk

    Chs Inc is recalling Solcon S Functional Soy Protein Concentrates produced in Israel due to potential Salmonella contamination. The product was distributed internationally and did not enter the U.S. market.

    Product
    Solcon S Functional Soy Protein Concentrates. Item No. / Item Description: 3232212 / Solcon S 110 GMO, and 32211 / Solcon S110 GMO
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1607-2013·2013-07-17

    Garden Highway Mango Medley Recalled for Potential Salmonella Contamination

    GHSW, LLC is recalling Garden Highway Mango Medley fruit cups due to potential Salmonella contamination from mangoes sourced from Agricola Daniella.

    Product
    Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Mango Medley Net Wt. 10 oz (284g) Renaissance Food Group LLC, Rancho Cordova, CA 95670, UPC: 826766214334 www.gardenhighway.com Ingredients: Cantaloupe, Pineapple, Mango, Red Grapes Packed in its own jui
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1624-2013·2013-07-17

    Eco-Cuisine Chocolate Chip Cookie Mix Recalled for Salmonella Risk

    Eco-Cuisine is recalling Chocolate Chip Cookie Mix due to potential Salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Chocolate Chip Cookie Mix, SKU: AA01COOK-CC, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1670-2013·2013-07-17

    Abbott Sovereign Compact Phacoemulsification System Recalled for Vacuum Loss Risk

    Abbott Medical Optics is recalling 534 Sovereign Compact Phacoemulsification Systems because they may lose vacuum tone mode during cataract surgery.

    Product
    Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1652-2013·2013-07-17

    Christian Cheese Horseradish Cheddar Cheese Recalled for Undeclared Soy

    Christian Cheese, LLC is recalling Horseradish Cheddar Cheese due to undeclared soy lecithin and soybean oil. The product was distributed in Colorado and Oklahoma.

    Product
    Christian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, and Horseradish. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1601-2013·2013-07-17

    Salmolux Recalls Wild Alaskan Nova Lox Smoked Salmon Due to Listeria Risk

    Salmolux is recalling Wild Alaskan Nova Lox Smoked Salmon due to potential Listeria monocytogenes contamination. The product was distributed in ten states.

    Product
    "***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD&C Red #40 (color enhancers), Natural Wood Smoke. CONTAINS: FISH (SALMON)*** Salmolux Federal Way, WA 98003***0 16468 44543 7***".
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1626-2013·2013-07-17

    Eco-Cuisine English Scone Mix Recalled for Salmonella Contamination Risk

    Eco-Cuisine is recalling English Scone Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1629-2013·2013-07-17

    Eco-Cuisine Muffin Mix Recalled for Potential Salmonella Contamination

    Eco-Cuisine is recalling 25 lb bags of Muffin Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Muffin Mix, SKU: CM25MUFF, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1625-2013·2013-07-17

    Eco-Cuisine Lemon Muffin Mix Recalled for Potential Salmonella Contamination

    Eco-Cuisine is recalling Lemon Muffin Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Lemon Muffin Mix, SKU: AA01MUFF-LM, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1585-2013·2013-07-17

    ABCO Laboratories Recalls Soy Protein Isolate Due to Supplier Recall

    ABCO Laboratories is recalling soy protein isolate products as part of a larger recall initiated by its supplier of soy-based products.

    Product
    Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was m
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1648-2013·2013-07-17

    Christian Cheese Vegetable Cheddar Recalled for Undeclared Soy Ingredients

    Christian Cheese, LLC is recalling Vegetable Cheddar cheese sold in Colorado and Oklahoma due to undeclared soy lecithin and soybean oil.

    Product
    Christian Cheese Vegetable Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Onion, Garlic, Basil, Red Bell Pepper, Black Pepper, Tomato, Vinegar, Parsley, Ginger, and Rosemary. 1 unit weighing approximately 0.6 lbs and p
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-754-2013·2013-07-17

    Olympia Pharmacy Recalls Metabolase Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Metabolase Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Metabolase Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1649-2013·2013-07-17

    Christian Cheese Ranch Bacon Cheddar Recalled for Undeclared Allergens

    Christian Cheese, LLC is recalling Ranch Bacon Cheddar cheese due to undeclared soy lecithin, soybean oil, and sulfites.

    Product
    Christian Cheese Ranch Bacon Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Ranch Dressing and Bacon Bits. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units w
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1636-2013·2013-07-17

    Allergy Research Group Recalls Wholly Immune Powder Due to Soy

    Allergy Research Group is recalling Wholly Immune Powder and Complete Immune Powder because they were manufactured with soy-based products.

    Product
    Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1647-2013·2013-07-17

    Christian Cheese Ranch Cheddar Recalled for Undeclared Soy Lecithin

    Christian Cheese, LLC is recalling approximately 15-16 units of Ranch Cheddar cheese distributed in Colorado and Oklahoma due to undeclared soy lecithin.

    Product
    Christian Cheese Ranch Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, and Ranch Dressing. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approxima
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1697-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 28 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-771-2013·2013-07-17

    Olympia Pharmacy Recalls Phenylbutazone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Phenylbutazone 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Phenylbutazone 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-716-2013·2013-07-17

    Olympia Pharmacy Recalls Deslorelin Vials Due to Sterility Concerns

    Olympia Pharmacy is recalling two vials of compounded Deslorelin 15 mg due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Deslorelin 15 mg vial, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement in terminal extension.

    Product
    REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1692-2013·2013-07-17

    DeRoyal Recalls Ortho Total Joint Tracecart Kits Due to Sterilization Concerns

    DeRoyal Industries is recalling 87 units of GEO-MED ORTHO TOTAL JOINT TRACECART kits because they contained Stryker togas with a potential sterilization problem.

    Product
    GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1674-2013·2013-07-17

    Fresenius Liberty Cycler Set Recalled for Potential Leakage During Dialysis

    Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.

    Product
    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 28 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1668-2013·2013-07-17

    Medtronic MiniMed Paradigm Insulin Infusion Sets Recalled for Malfunction Risk

    Medtronic MiniMed is recalling Paradigm insulin infusion sets because they may malfunction and deliver incorrect insulin volumes if exposed to fluids.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.

    Product
    REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1701-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1711-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 37 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone to impinge on the bearing.

    Product
    REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1695-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1705-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 32 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1717-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.

    Product
    REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1706-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 30 units of Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement.

    Product
    REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1677-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-709-2013·2013-07-17

    Olympia Pharmacy Recalls Caco/Copper Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Caco/Copper 6.2 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Caco/Copper 6. 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1598-2013·2013-07-17

    Salmolux Recalls Cold Smoked Sockeye Salmon for Listeria Risk

    Salmolux is recalling specific cold smoked sockeye salmon products due to potential contamination with Listeria monocytogenes. The products were distributed in ten states.

    Product
    SOCKEYE SALMON: 1) "***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: SOCKEYE SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 2) "***SOCKEYE SMOKED SALMON TRIM***NET W
    Category
    Food
    Distribution
    10 states
  • HighCPSC·13239·2013-07-17

    UCO Arka LED Lanterns Recalled Due to Fire Hazard

    Industrial Revolution is recalling UCO Arka LED lanterns sold at REI because the wall charger plug can fail and cause a fire.

    Product
    UCO Arka LED lanterns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap and distal male Luer connection.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1595-2013·2013-07-17

    Granna's Tuna Mac and Vegetable Products Recalled for Undeclared Egg

    Granna's, LLC is recalling specific Tuna Mac, Italian Blend Vegetables, and Spiced Apple Rings products due to undeclared egg. All affected packages were distributed in Oklahoma.

    Product
    Granna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1642-2013·2013-07-17

    GKI Recalls Dark Chocolate Covered Cherries Due to Undeclared Sulfites

    GKI Foods is recalling 259 cases of Dark Chocolate Covered Dried Balaton Cherries because they were mixed with strawberries containing undeclared sulfites.

    Product
    Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries Net Wt. 25 lbs Product of USA Traverse City, MI 49684
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1643-2013·2013-07-17

    Caribena Brand Papayas Recalled Due to Potential Salmonella Contamination

    Caribe Produce is recalling Caribena Brand papayas from Mexico due to potential Salmonella contamination. The product was distributed in New Jersey and North Carolina.

    Product
    Caribena Brand papayas packed in 35 lb. cartons marked with the brand "Caribena" and "Product of Mexico" stamped on the side. Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com" Papayas are packed in boxes of 8-12 papa
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1623-2013·2013-07-17

    Eco-Cuisine Sausage Style Quick Mix Recalled for Salmonella Risk

    Eco-Cuisine is recalling Reduced Sodium Sausage Style Quick Mix due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Reduced Sodium "Sausage Style" Quick Mix, SKU: AA10SGQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1641-2013·2013-07-17

    Chs Inc Recalls Contex Textured Soy Protein Due to Salmonella Risk

    Chs Inc is recalling specific batches of Contex textured soy protein produced in Israel due to potential Salmonella contamination. The product was distributed nationwide and to multiple international countries.

    Product
    Contex - Textured Soy Protein Concentrates Item No. / Item Description: 3411112 / Contex 120 Textured Soy Protein, 3411124 / Contex 25 Textured Soy Protein, 3411129 / Contex 31 CL Textured Soy Protein, 3411142 / Contex 120CL IP Textured Soy Protein, 3411144 / Contex 240 Textu
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1684-2013·2013-07-17

    Baxter Recalls Arthroscopic Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare Corp. is recalling Four Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1688-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Dual Camera Controllers for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Dual Camera Controllers because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1682-2013·2013-07-17

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Packaging Pinholes

    Baxter Healthcare is recalling 356,728 units of Four Lead TUR irrigation sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder ir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-686-2013·2013-07-17

    Hospira Recalls Gentamicin Sulfate Injection Due to Visible Particulate Matter

    Hospira Inc. is recalling 168,300 vials of Gentamicin Sulfate Injection USP 80 mg/2 mL because visible particles were found floating in the primary container.

    Product
    GENTAMICIN SULFATE — GENTAMICIN SULFATE (GENTAMICIN SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1725-2013·2013-07-17

    SagaTech Finger Sensor for Remmers Recorder Recalled for Premature Jacket Recession

    SagaTech Electronics is recalling 152 Finger Sensors for Remmers Recorders because the outer jacket is receding prematurely from the black sensor.

    Product
    Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1689-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Instrument Control Boxes

    Intuitive Surgical is recalling 30 da Vinci Instrument Control Boxes because factory testing may not have met UL standards due to a malfunctioning test device.

    Product
    da Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1667-2013·2013-07-17

    Bryan Medical Recalls Mislabeled Pediatric Tracheostomy Tubes

    Bryan Medical Inc is recalling 5 units of Tracoe Mini 3.0mm pediatric tracheostomy tubes because they were mislabeled as smaller infant tubes.

    Product
    Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1676-2013·2013-07-17

    Zimmer Recalls Mislabelled Shoulder Trial Stem Devices

    Zimmer, Inc. is removing one lot of Bigliani/Flatow Humeral Provisional Stems because 14mm devices were incorrectly etched and packaged as 12mm.

    Product
    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2013·2013-07-17

    AngioDynamics RITA Main Cable Recalled for Incorrect Instructions for Use

    AngioDynamics is recalling 13 RITA Main Cables because they contain incorrect Instructions for Use. The cables are used with RITA RF Generators and electrosurgical devices.

    Product
    AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1683-2013·2013-07-17

    Baxter Arthroscopic Irrigation Sets Recalled Due to Packaging Pinholes

    Baxter Healthcare is recalling Two Lead Arthroscopic Irrigation Sets because pinholes in the packaging could compromise sterile barrier properties.

    Product
    Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Vision System Carts

    Intuitive Surgical is recalling 30 da Vinci Si Vision System Carts because factory testing may not have complied with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended f
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-690-2013·2013-07-17

    Teva Recalls Camila Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Camila (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1598-2013·2013-07-17

    Toshiba Kalare Diagnostic X-Ray System Recalled for Image Quality Defect

    Toshiba American Medical Systems is recalling 153 Kalare Diagnostic X-Ray Systems because the large focus heats up unexpectedly, causing brighter images than expected.

    Product
    TOSHIBA Kalare Diagnostic X-Ray System K110785
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1672-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheters Due to Incorrect Sheath Packaging

    Boston Scientific is recalling 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.

    Product
    NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-787-2013·2013-07-17

    Olympia Pharmacy Recalls Trimix Due to Sterility Concerns

    Olympia Pharmacy is recalling 24 units of compounded Trimix nationwide and in Puerto Rico due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Trimix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-689-2013·2013-07-17

    Teva Recalls Errin Norethindrone Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Errin (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1644-2013·2013-07-17

    R.L. Schreiber Batter Mix Recalled for Undeclared Red 40

    R.L. Schreiber Inc. is recalling 823 units of Batter Mix because the product contains undeclared Red 40 and does not meet quality specifications for color.

    Product
    R.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case.
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-687-2013·2013-07-17

    Sun Pharmaceutical Recalls Nimodipine Capsules Due to Crystallization

    Sun Pharmaceutical Industries Inc. is recalling Nimodipine Capsules 30 mg due to crystallization of the active ingredient.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1651-2013·2013-07-17

    Christian Cheese Blackberry Wine Cheese Recalled for Undeclared Sulfites

    Christian Cheese, LLC is recalling Blackberry Wine Cheese made in Kingfisher, Oklahoma, due to undeclared sulfites. The product was distributed in Colorado and Oklahoma.

    Product
    Christian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, Blackberry Wine. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units wei
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-684-2013·2013-07-17

    Teva Recalls Balziva Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Balziva (norethindrone and ethinyl estradiol) tablets because an impurity was detected during testing.

    Product
    BALZIVA — BALZIVA (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2013·2013-07-17

    Intuitive Surgical Recalls da Vinci Si Surgeon Side Carts for Testing Compliance

    Intuitive Surgical is recalling 30 da Vinci Si Surgeon Side Carts because factory testing may not comply with UL standards due to a malfunctioning test device.

    Product
    da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended fo
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-688-2013·2013-07-17

    Fresenius Kabi Recalls Folic Acid Injection Due to Impurities

    Fresenius Kabi USA is recalling 80,480 vials of Folic Acid Injection due to failed impurities and degradation specifications.

    Product
    Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-691-2013·2013-07-17

    West-ward Recalls Nicardipine Hydrochloride Injection Due to Impurity

    West-ward Pharmaceutical Corp. is recalling specific lots of Nicardipine Hydrochloride Injection because they failed impurity specifications for a degradation product.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-681-2013·2013-07-17

    Teva Recalls Lessina Oral Contraceptives Due to Impurity Detection

    Teva Pharmaceuticals is recalling Lessina oral contraceptives because an impurity was detected during testing. The FDA classifies this as a Class III recall.

    Product
    LESSINA — LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-683-2013·2013-07-17

    Teva Recalls Jolessa Birth Control Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling specific lots of Jolessa birth control tablets because an impurity was detected during testing.

    Product
    JOLESSA — JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-682-2013·2013-07-17

    Teva Recalls Junel Oral Contraceptive Due to Impurity Detection

    Teva Pharmaceuticals is recalling Junel oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.

    Product
    JUNEL — JUNEL (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1671-2013·2013-07-17

    Boston Scientific Recalls Rigiflex Balloon Dilator for Incorrect Expiration Date

    Boston Scientific is recalling 91 units of the Rigiflex Single-Use Achalasia Balloon Dilator because they were labeled with an incorrect expiration date.

    Product
    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V312000·2013-07-16

    Suzuki Recalls 2013 Hayabusa Motorcycles Due to ABS Malfunction

    Suzuki is recalling 2,561 model year 2013 GSX1300RA Hayabusa motorcycles because a manufacturing error may cause the Anti-Lock Brake System to malfunction, increasing crash risk.

    Product
    SUZUKI — SUZUKI HAYABUSA GSX1300RA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V314000·2013-07-16

    Lotus Recalls 2011 Evora Vehicles Due to Oil Hose Chafing Risk

    Lotus is recalling 80 model year 2011 Evora supercharged vehicles with manual transmissions because the engine oil cooler hose may chafe and rupture, leading to oil loss.

    Product
    LOTUS — LOTUS EVORA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V311000·2013-07-16

    HL Enterprise Recalls 2013 Trailers Due to Awning Motor Screw Failure

    HL Enterprise is recalling 2013 Hyline, Georgian Bay, Bridgeview, and Premier trailers because power awning motor screws may shear, causing the awning to unfurl unexpectedly.

    Product
    HY-LINE — HY-LINE, BRIDGEVIEW, GEORGIAN BAY HY44, HY42IKEB, BV42IKWT, GB39CKT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V313000·2013-07-16

    Morgan 3W Recall: Missing Brake Fluid Warning Label

    Morgan is recalling 2012-2013 3W motorcycles because the brake fluid reservoir lacks a required filling warning label, which may reduce brake performance.

    Product
    MORGAN — MORGAN 3W
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V309000·2013-07-15

    Glaval Buses Recalled for Loose Air Conditioner Evaporator Units

    Glaval is recalling certain 2010-2013 buses because the rear air conditioner evaporator may detach from the ceiling, posing an injury risk.

    Product
    GLAVAL BUS — GLAVAL BUS, GLAVAL CONCORDE II, LEGACY, UNIVERSAL, ENTOURAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V301000·2013-07-15

    Lakota Recalls 2014 Charger and Bighorn Trailers for Awning Motor Defect

    Lakota is recalling 2014 Charger and Bighorn recreational trailers because a design change may cause awning motor screws to shear, potentially leading to unexpected awning deployment and injury.

    Product
    LAKOTA — LAKOTA CHARGER, BIGHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13742·2013-07-11

    Staples Recalls Bermond Fabric Manager's Chairs Due to Base Breakage

    Staples is recalling Bermond Fabric Manager's Chairs because the base can break, posing a fall hazard. Consumers should stop using the chairs and contact Staples for a refund.

    Product
    Bermond Fabric Manager's Chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13236·2013-07-11

    Hollis Recalls Digital Dive Computers Due to Drowning Hazard

    Hollis is recalling DG03 dive computers because a malfunctioning pressure reading could cause divers to deplete their air supply and drown.

    Product
    Hollis DG03 Dive Computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V310000·2013-07-11

    Kawasaki Recalls 2013 EX300 Motorcycles Due to ABS Malfunction

    Kawasaki is recalling 1,083 model year 2013 EX300 motorcycles because a manufacturing error may cause the Anti-Lock Brake System to malfunction, increasing crash risk.

    Product
    KAWASAKI — KAWASAKI EX300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1587-2013·2013-07-10

    Hannaford Oatmeal Raisin Cookies Recalled for Undeclared Tree Nuts

    Delhaize America is recalling Hannaford Gourmet Oatmeal Raisin Cookies because they may contain undeclared tree nuts. The product was sold in five northeastern states.

    Product
    Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-625-2013·2013-07-10

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling specific lots of 5% Dextrose Injection due to a manufacturing defect that may compromise sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-653-2013·2013-07-10

    Clinical Specialties Compounding Pharmacy Recalls Methionine/Choline/Inositol/B-12 Injection

    Clinical Specialties Compounding Pharmacy is recalling Methionine/Choline/Inositol/B-12 products due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Methionine/Choline/Inositol/ B-12, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
    Category
    Drug
    Distribution
    3 states

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