The Recall Desk

Archive

September 2012 recalls

607 recalls were announced in September 2012.

What the numbers show

Critical
135
Severe
154
High
210
Moderate
83
Low
25

Of the 607 recalls this month scored against our rubric, 22% are Critical, 25% are Severe.

1–100 of 607

  • SevereNHTSA·12V475000·2012-09-28

    BMW Recalls 2013 M5 and M6 Vehicles Due to Oil Pump Defect

    BMW is recalling 2013 M5 and M6 vehicles because a manufacturing error could cause the engine oil pump to fail, leading to engine stall and crash risk.

    Product
    BMW — BMW M6, M5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V472000·2012-09-27

    Autocar Recalls Xpeditor Trucks Due to Rearward Rollaway Alarm Defect

    Autocar is recalling 542 Xpeditor trucks because a faulty motion sensor may prevent the rearward rollaway alarm from sounding, increasing the risk of hitting pedestrians or other vehicles.

    Product
    AUTOCAR — AUTOCAR XPEDITOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V473000·2012-09-27

    Navistar Recalls IC Transit Buses Due to Engine Oil Line Leak Risk

    Navistar is recalling 1,168 IC transit buses from model years 2006-2010 because a high-pressure engine oil line may leak or rupture, potentially causing an engine compartment fire.

    Product
    IC — IC, IC BUS 3300, FECB, CECB, HCCB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V476000·2012-09-27

    Navistar Recalls IC School Buses Due to Oil Line Leak Risk

    Navistar is recalling 2006-2011 IC school buses because a high-pressure oil line may leak or rupture, potentially causing an engine stall or fire.

    Product
    IC BUS — IC BUS FESB, RESB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12751·2012-09-27

    ADS Recalls Cyclone Swing Seats Due to Fall Hazard

    ADS is recalling Cyclone Swing Seats because the plastic can break during use, posing a fall hazard to children. No injuries have been reported.

    Product
    Cyclone Swing Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12C003000·2012-09-27

    Evenflo Big Kid Booster Seats Recalled for Missing Manuals

    Evenflo recalls specific Big Kid booster seats shipped to institutional customers without instruction manuals or registration cards, increasing crash injury risk.

    Product
    EQUIPMENT:OTHER:LABELS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12285·2012-09-27

    Captain Cutlass Toy Pirate Pistols Recalled for Lead Paint Violation

    Dillon Importing is recalling Captain Cutlass Toy Pirate Pistols because the surface paint contains excessive lead, violating federal standards. No injuries have been reported.

    Product
    Captain Cutlass Toy Pirate Pistols
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·12283·2012-09-27

    Cabot Wood Cleaner and Brightener Recalled for Chemical Leak Hazard

    Cabot is recalling Wood Cleaner and Wood Brightener products with spray pumps because the seal can fail, causing chemical leaks that may burn skin or eyes.

    Product
    Wood Cleaner and Wood Brightener in container with spray pump.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2343-2012·2012-09-26

    F&S Produce Recalls Fresh Cut Mango Chunks Due to Salmonella Risk

    F&S Produce Co. is recalling fresh-cut mango chunks with best-by dates on or before August 28, 2012, due to a potential Salmonella contamination risk.

    Product
    Fresh Cut Fruit Mango Chunks 1/5 lbs Best Use By: 08/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 No UPC
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2342-2012·2012-09-26

    F&S Produce Recalls Fresh Cut Mangoes Due to Salmonella Risk

    F&S Produce is voluntarily recalling fresh-cut mangoes with best-by dates on or before August 28, 2012, due to potential Salmonella contamination.

    Product
    Garden Pure Fresh Cut Mango 9 oz .(255 g) Best By: 08/28/12 and before Packed by F& S Produce Co. Inc. Headquarters, Rosehayn, NJ 06532 UPC 8 01172 20149 5
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2339-2012·2012-09-26

    F&S Produce Recalls Expired Delish Mango and Berry Mix Due to Salmonella Risk

    F&S Produce is voluntarily recalling expired Delish Mango & Berry Mix because related Daniella brand mangoes may be contaminated with Salmonella.

    Product
    Delish Mango & Berry Mix 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 0 49022 63779 5
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2357-2012·2012-09-26

    Chamberlain Farms Recalls 2012 Cantaloupes Due to Salmonella Concerns

    Chamberlain Farms Inc. is voluntarily recalling 2012 cantaloupes due to potential Salmonella contamination. The recall covers specific states and counties.

    Product
    Whole Cantaloupe. Both unlabeled and labeled "MIDWEST BEST" PRODUCE INC. HOMEGROWN CANTALOUPE #4319 PRODUCT OF THE USA
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-2347-2012·2012-09-26

    F&S Produce Recalls Trader Joe's Tropical Fruit Medley Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling Trader Joe's Tropical Fruit Medley because it may contain mangoes contaminated with Salmonella.

    Product
    Trader Joe's Tropical Fruit Medley, 16 oz, Best By: 08/28/12 and before Dist. & Sold exclusively by: Trader Joe's, Monorovia, CA 91016 UPC 00949361
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2337-2012·2012-09-26

    F&S Produce Recalls Fresh-Cut Mangoes Due to Salmonella Contamination

    F&S Produce is voluntarily recalling expired fresh-cut mangoes distributed by Walgreens due to potential Salmonella contamination.

    Product
    Delish Fruit Burst 10 oz.(283 g) Enjoy by: 8/28/12 Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 049022 55862 5
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2332-2012·2012-09-26

    World Foods Recalls Tropical Salsa Products Due to Salmonella Risk

    World Foods, LLC is recalling Tropical Salsa products containing Daniella Mangoes distributed in Florida due to potential Salmonella contamination.

    Product
    Tropical Salsa Product is labeled in part: "***FRESH***Garden Highway***Fresh Party Favorites!***PERISHABLE***KEEP REFRIGERATED***Tropical Salsa***Net Wt. 11 oz (312 g)***Best if Sold By***Renaissance Food Group LLC***Rancho Cordova, CA 95670***1-888-4 -HWYFUN***www.gardenhighwa
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2362-2012·2012-09-26

    Triple B Corporation Recalls Cut Tropical Mixed Fruit for Salmonella Risk

    Triple B Corporation is recalling Cut Tropical Mixed Fruit because it may be contaminated with Salmonella. The product was distributed in Alaska and Washington.

    Product
    Cut Tropical Mixed Fruit has the item #028-00165 and the UPC is 0 45009 00165 8. Metropolitan Market Label is read in part " Cut Mango / Papaya w/ Lime Net Weight 10 oz (284 g.) Distributed By metropolitan market *** Seattle, WA***".
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-2345-2012·2012-09-26

    F&S Produce Recalls Expired Garden Pure Holiday Fruit Bowls

    F&S Produce Co. is voluntarily recalling expired Garden Pure Holiday Fruit Bowls containing fresh-cut mangoes due to potential Salmonella contamination.

    Product
    Garden Pure Holiday Fruit Bowl 4 lbs (1.81kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 UPC 6 01172 00264 1
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2330-2012·2012-09-26

    Wellsley Farms Nova Salmon Recalled for Listeria Contamination

    Spence & Co. is recalling Wellsley Farms 1 LB Nova Salmon because it tested positive for Listeria monocytogenes. Consumers should discard the product.

    Product
    Wellsley Farms 1 LB Nova Salmon
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-2341-2012·2012-09-26

    F&S Produce Recalls Tropical Mango Spinach Salad Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling Garden Highway Tropical Mango Spinach Salad because the mangoes may be contaminated with Salmonella.

    Product
    Garden Highway Tropical Mango Spinach Salad with Zesty Orange Vinaigrette 7 oz .(198 g) Best if sold by: 8/28/12 and before Distributed by: Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 801850 5
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2356-2012·2012-09-26

    Hocean Recalls Nitre Powder Lacking Required Directions for Use

    Hocean Inc is recalling Nitre powder because the label lacks required directions for use, which could lead to overuse and life-threatening health hazards.

    Product
    Nitre powder. Brand "Selected Product", 4oz plastic bags, UPC 0 45027 97918 2.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2344-2012·2012-09-26

    F&S Produce Recalls Expired Garden Pure Mixed Fruit Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling expired Garden Pure Mixed Fruit containing fresh-cut mangoes due to a potential Salmonella contamination risk identified in related products.

    Product
    Garden Pure Mixed Fruit Net Wt. 48 oz (1.36 kg) Best By: 8/28/12 and before F& S Produce Co. Inc. Headquarters, Rosenhayn, NJ 08532 6 001172 00264 1
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2336-2012·2012-09-26

    F&S Produce Recalls Expired Fresh-Cut Mango Products Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling expired fresh-cut mango products prepared for Walgreens due to a potential Salmonella contamination risk identified in related products.

    Product
    Delish Pineapple, Mango and cantaloupe Spears Net Wt. 5 oz. Enjoy by: 8/28/2012 and before Prepared for: Walgreens Inc. Deerfield, Illinois, 60015 Distributed by Walgreens UPC 0 49022 537019
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-2361-2012·2012-09-26

    Triple B Corporation Recalls Fresh Tropical Fruit Mix for Salmonella Risk

    Triple B Corporation is recalling Fresh Tropical Fruit Mix because it may be contaminated with Salmonella. The product was distributed in Alaska and Washington.

    Product
    Fresh Tropical Fruit Mix has the Item # 027-01480, and the UPC is 0 45009 01480 1. Haggen Label reads in part "HAGGAEN'S ORIGINAL *** Tropical Mixed Fruit *** Ingredients: Fresh Pineapple, Papaya, Mango & Kiwi ***Distributed with Pride by: Haggen, Inc., Bellingham, WA ***
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-2329-2012·2012-09-26

    Spence & Co Smoked Salmon Trim Recalled for Listeria

    Spence & Co. is recalling 8oz Smoked Salmon Trim because it tested positive for Listeria monocytogenes.

    Product
    Spence & Co Ltd brand 8oz Smoked Salmon Trim
    Category
    Food
    Distribution
    16 states
  • SevereFDA (Food)·F-2364-2012·2012-09-26

    Triple B Corporation Recalls Seasonal Berries Due to Salmonella Risk

    Triple B Corporation is recalling specific lots of Seasonal Berries packed by Charlie's Produce because they may contain Salmonella.

    Product
    Seasonal Berries with the Item # 028-02071 and the UPC for case 0 45009 02063 5, UPC for package 0 45009 02017 8; Case label reads in part "***ALASKA CARROT Seasonal Berries 6/8 oz *** Packed By: Charlie's Produce, Anchorage, AK***"; Package label reads in part "***Seasonal B
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2390-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 LAS Analyzer Recalled for Fibrinogen Errors

    Instrumentation Laboratory is recalling ACL TOP 700 LAS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2312-2012·2012-09-26

    Senna Pods Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Co. is recalling Senna Pods Whole due to a pervasive mouse infestation found in the facility by CA inspectors.

    Product
    Senna Pods Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2365-2012·2012-09-26

    Daniella Brand Mangos Recalled Due to Potential Salmonella Contamination

    Triple B Corporation is recalling Daniella brand mangos because they have the potential to be contaminated with Salmonella.

    Product
    Fruit Bowls: 1) Seasonal Fruit Bowl (Walmart) Item # 028-06480***" and the UPC of the package is 0 45009 06480 6 and Case UPC is 0 45009 06480 6. Case label reads in part "***ALASKA CARROT Seasonal Fruit Bowl 6/40 oz *** Packed By: Charlie's Produce, Anchorage, AK***" Use By 7
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2350-2012·2012-09-26

    ProBalance Protein To Go Recalled for Potential Botulism Risk

    Protica, Inc. is recalling ProBalance Protein To Go caffeinated French Vanilla Latte bottles because the product was not sufficiently acidified, posing a potential risk of Clostridium botulinum contamination.

    Product
    ProBalance Protein To Go(TM), Caffeinated French Vanilla Latte, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2154-2012·2012-09-26

    American Licorice Recalls Red Vines Mixed Bites Due to Lead

    American Licorice Co is recalling Red Vines Mixed Bites because California health officials found elevated lead levels in the product.

    Product
    RED VINES Mixed Bites; Red and Black licorice mixed bites. UPC: 4136400288 and 4136451277. Family Mix Half Pallet; UPD 4136421697; Family Mix PDQ; UPC 4136455297; Mixed Original Red/Black Licorice Bag Pallet; UPC 413466283; Family Mix 1/4 pallet; UPC 4136424097; 96/5 ox mix
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1679-2012·2012-09-26

    Hospira Recalls Carboplatin Injection Due to Embedded Glass Particles

    Hospira Inc. is recalling Carboplatin Injection vials because visible particles are embedded in the glass neck, posing a risk of dislodging into the solution.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2352-2012·2012-09-26

    Protica Recalls Protein Shots Due to Insufficient Acidification

    Protica, Inc. is recalling 6,912 vials of Protein Shots, Orange Sunshine Flavor, because the product was not sufficiently acidified, posing a risk of Clostridium botulinum contamination.

    Product
    Protein Shots, Orange Sunshine Flavor, 2.9 fl oz (Responsible firm on label: Body Choice Nutrition, Inc., 1595 Peachtree Park Way, Suite 204, Cumming, GA 30041)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2313-2012·2012-09-26

    Spearmint Leaf Organic Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Spearmint Leaf Organic due to a pervasive mouse infestation found by CA inspectors.

    Product
    Spearmint Leaf Organic C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2366-2012·2012-09-26

    Daniella Brand Mangoes Recalled for Potential Salmonella Contamination

    Triple B Corporation is recalling Daniella brand mangoes due to potential Salmonella contamination. The product was distributed in Alaska and Washington.

    Product
    Fruit Cup has Item # 028-07140, and the UPC 0 45009 07140 8. Label reads in part "*** ALASKA CARROT Fruit Cup Mango / Red Grape 42/4 oz *** Packed By: Charlie's Produce, Anchorage, AL***". Use By 8/22/12 through 9/01/12.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2360-2012·2012-09-26

    Tres Monjitas Pineapple and Guava Beverage Recalled for Undeclared Allergen

    Vaqueria Tres Monjitas, Inc. is recalling its Pineapple and Guava Beverage because it contains undeclared sodium caseinate, a milk derivative.

    Product
    "Tres Monjitas***Pineapple and guava beverage***Distribuido por Vaquer¿a Tres Monjitas Inc***" Package sizes: gallons, 1/2 gallons, quarts, 14 oz and 8 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2349-2012·2012-09-26

    ProBalance Protein Shake Recalled for Potential Botulism Risk

    Protica, Inc. is recalling ProBalance Protein To Go Milk Chocolate Shakes because the product was not sufficiently acidified, creating a potential risk for Clostridium botulinum contamination.

    Product
    ProBalance Protein To Go(TM), Milk Chocolate Shake, Dietary Supplement, Net Wt 2.5 fl oz (Responsible firm on labeling: Pro Balance LLC, 4070 Tampa Road, Oldsmar, FL 34677)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2346-2012·2012-09-26

    F&S Produce Recalls Fresh-Cut Mangoes Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling Signature Cafe Fruit Basket Medley containing fresh-cut mangoes due to a potential Salmonella contamination risk.

    Product
    SIgnature Cafe Fruit Basket Medley, 30 oz, Use By: AUG 28 12 and before Distributed by Lucerne Foods, Inc., PO Box 99, Pleasonton, CA 94566-0009 1-877-232-4271 UPC 0 2113006918 7
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-2334-2012·2012-09-26

    World Foods Recalls Cut Fruit Products Due to Salmonella Risk

    World Foods, LLC is recalling cut fruit products containing Daniella Mangoes distributed in Florida due to potential Salmonella contamination.

    Product
    Fresh Fruit Product is labeled in part: "***Fruit Burst Bowl***1 LB (454g)***Best If Sold By***Ingredients: Watermelon, Cantaloupe, Pineapple, Honeydew, Grapes, Mango, Blueberries.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2148-2012·2012-09-26

    Red Vines Black Licorice Twists Recalled Due to Elevated Lead Levels

    American Licorice Co is recalling Red Vines Black Licorice Twists because the California Department of Public Health found elevated lead levels in random samples.

    Product
    Red Vines Black Licorice Twists; No preservatives and Always Fat Free Packaged in the following configurations: One Pound Pac: Red and white Plastic bag with a window to display licorice twists. UPC 0 41364 00283 5; 5 oz Black Licorice Tray Pack; UPC 4136451277 and 4136450277
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2395-2012·2012-09-26

    Hospira Recalls Empty Evacuated Containers Due to Embedded Iron Oxide Glass Defect

    Hospira Inc. is recalling 191,094 units of Empty Evacuated Containers (250 mL and 1000 mL) because an embedded iron oxide glass defect may break off into the solution.

    Product
    Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1681-2012·2012-09-26

    Hospira Recalls Methotrexate Injection Due to Embedded Glass Particles

    Hospira Inc. is recalling Methotrexate Injection vials because visible particles embedded in the glass neck may dislodge into the solution.

    Product
    METHOTREXATE — METHOTREXATE (METHOTREXATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2340-2012·2012-09-26

    F&S Produce Recalls Expired Fresh-Cut Mango Medley Due to Salmonella Risk

    F&S Produce Co. is voluntarily recalling expired Garden Highway Fresh Fruit Mango Medley products due to a potential Salmonella contamination risk identified in related Daniella brand mangoes.

    Product
    Garden Highway Fresh Fruit Mango Medley 1 lb .(454 g) Best if sold by: 8/28/12 and before Renaissance Food Group LLC Rancho Cordova, CA 95670 UPC 8 26766 21437 2
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-2303-2012·2012-09-26

    Hops Flower Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Hops Flower due to a pervasive mouse infestation found in their facility by CA inspectors.

    Product
    Hops Flower; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2322-2012·2012-09-26

    Peppermint Leaf Organic Recalled Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Peppermint Leaf Organic due to a mouse infestation found in its facility.

    Product
    Peppermint Leaf Organic, Large Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1674-2012·2012-09-26

    Carefusion Recalls ChloraPrep Applicators Due to Incomplete Seals

    Carefusion is recalling 67,775 ChloraPrep with Tint applicators because some units had incomplete seals, potentially compromising sterility.

    Product
    ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2167-2012·2012-09-26

    American Licorice Recalls Original Snaps Classic Chewy Candy Due to Lead

    American Licorice Co is recalling Original Snaps Classic Chewy Candy because the California Department of Public Health found elevated lead levels in a related product.

    Product
    Original Snaps Classic Chewy Candy; packed in 5.5 oz bags, 4.5 oz theatre box and 12 oz. tins. UPC 5.5 oz - 4136408300; 4.5 oz Theatre Box UPC 4136408302; Theatre box shipper UPC 4136408295. 12 oz tin UPC 4136408299; American Licorice Company Union City, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2360-2012·2012-09-26

    Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures

    Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.

    Product
    BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2301-2012·2012-09-26

    Green Tea Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Green Tea, Gunpowder C/S due to a pervasive mouse infestation found in the facility by CA inspectors.

    Product
    Green Tea, Gunpowder C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2363-2012·2012-09-26

    Triple B Corporation Recalls Cut Seasonal Fruit for Salmonella Risk

    Triple B Corporation is recalling cut seasonal fruit products due to potential Salmonella contamination. The products were distributed in Alaska and Washington.

    Product
    Cut Seasonal Fruit -Item # 028-00172 - Net Weight 20 oz UPC 045009 00172 6; Cut Seasonal Fruit - Item # 028-00173 - Net Weight 10 oz UPC 0 45009 00173 3; Label reads in part "CUT SEASONAL FRUIT Ingredients: Pineapple, Mango, Papaya, Strawberries, Grapes & Kiwi*** Distribute
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2352-2012·2012-09-26

    Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues

    Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.

    Product
    CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2354-2012·2012-09-26

    Custom Medical Specialties Recalls PVP Prep Solution Due to Microbial Testing Failures

    Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.

    Product
    CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2355-2012·2012-09-26

    Custom Medical Specialties Recalls Radiology Drainage Packs with PVP Prep Solution

    Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.

    Product
    CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2316-2012·2012-09-26

    Paprika Sweet Flakes Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Paprika Sweet Flakes because inspectors found a pervasive mouse infestation in the facility.

    Product
    Paprika Sweet Flakes; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2351-2012·2012-09-26

    Protein Wave Tropical Fruit Gelatin Recalled for Botulism Risk

    Protica, Inc. is recalling 2,928 cups of Protein Wave Tropical Fruit Gelatin because the product was not sufficiently acidified, posing a potential risk of Clostridium botulinum contamination.

    Product
    Protein Wave 15 grams of protein, Tropical Fruit Gelatin (Responsible firm on label: Nutritional Resources, Inc., 5003 Wrightsboro Road, Grovetown, GA 30813)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2310-2012·2012-09-26

    Rose Hips Organic Whole Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Rose Hips Organic Whole because inspectors found a pervasive mouse infestation in the facility.

    Product
    Rose Hips Organic Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2353-2012·2012-09-26

    Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.

    Product
    CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2324-2012·2012-09-26

    Mullein Leaf Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Mullein Leaf, Whole, Lot 110200, after inspectors found a pervasive mouse infestation in the facility.

    Product
    Mullein Leaf, Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2012·2012-09-26

    Steris Recalls 5085 Surgical Tables Due to Hydraulic Column Damage

    Steris is recalling 379 surgical tables because external impact damage to the hydraulic column can misalign shrouds and impede table movement.

    Product
    STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2385-2012·2012-09-26

    Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws

    Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.

    Product
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Sc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2315-2012·2012-09-26

    Olive Leaf Organic Recalled Due to Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Olive Leaf Organic due to a mouse infestation found in its facility by California health inspectors.

    Product
    Olive Leaf Organic; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm prior
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2325-2012·2012-09-26

    Peppermint Leaf Organic C/S Recalled Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Peppermint Leaf Organic C/S because inspectors found a pervasive mouse infestation in the facility.

    Product
    Peppermint Leaf Organic C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2298-2012·2012-09-26

    Roundy's Rich Fields Butter Cookies Recalled for Bacillus cereus

    Atico International USA is recalling Roundy's Rich Fields Butter Cookies due to the presence of Toxigenic Bacillus cereus found in an FDA sample.

    Product
    Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat Flou
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-1682-2012·2012-09-26

    Hospira Recalls Paclitaxel Injection Due to Embedded Glass Particles

    Hospira Inc. is recalling Paclitaxel Injection vials because visible particles are embedded in the glass at the neck. The particles may dislodge into the solution.

    Product
    PACLITAXEL — PACLITAXEL (PACLITAXEL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2300-2012·2012-09-26

    Chicory Root Granules Recalled Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Chicory Root Roasted Granules because inspectors found a pervasive mouse infestation in the facility.

    Product
    Chicory Root Roasted Granules Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2319-2012·2012-09-26

    Green Gun Powder Tea Recalled Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Green Gun Powder Tea due to a mouse infestation found in its facility.

    Product
    Tea green, Gun Powder, C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2386-2012·2012-09-26

    Philips Recalls MX 16-slice CT Scanners Due to Bolt Failure Risk

    Philips Medical Systems is recalling 328 MX 16-slice CT Scanner Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2299-2012·2012-09-26

    Carob Raw Powder Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Carob Raw Powder because inspectors found a pervasive mouse infestation in the facility.

    Product
    Carob Raw Powder Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2321-2012·2012-09-26

    Organic Yerba Mate Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Organic Yerba Mate after inspectors found a pervasive mouse infestation in the facility.

    Product
    Organic Yerba Mate; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1675-2012·2012-09-26

    Dukal Recalls ZEE Antiseptic Wipes Due to Microbial Contamination

    Dukal Corp. is recalling ZEE Antiseptic Wipes due to contamination with Burkholderia cepacia. The affected products were distributed nationwide.

    Product
    ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2304-2012·2012-09-26

    Marigold Petals Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Marigold Petals Whole due to a pervasive mouse infestation found in the facility by CA inspectors.

    Product
    Marigold Petals Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2320-2012·2012-09-26

    San Francisco Herb Recalls Black Tea Due to Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling black tea after inspectors found a pervasive mouse infestation in the facility.

    Product
    Tea black, China T/B Cut; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2333-2012·2012-09-26

    World Foods Recalls Cut Fruit and Salsa Products Due to Salmonella Risk

    World Foods, LLC is recalling cut fruit and salsa products containing Daniella Mangoes distributed in Florida due to potential Salmonella contamination.

    Product
    Fresh Fruit Product is labeled in part: "***Fresh Island Medley***1 LB (454g)***Best If Sold By***Ingredients: Pineapple, Mango, Papaya.***Packed in its own juice***Distributed by: Winn-Dixie Stores Inc. Jacksonville, FL 32254***For Nutrition Information Call 1-888-449-9386***
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2327-2012·2012-09-26

    TWI Foods Crispy Punjabi Cookies Recalled for Undeclared Milk

    Indian Foods & Spices, LLC is recalling Crispy Punjabi Cookies because some packages may not list milk as an ingredient.

    Product
    Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2309-2012·2012-09-26

    Pau D'Arco Bark Recalled Due to Mice Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Pau D'Arco Bark C/S because inspectors found a pervasive mouse infestation in the facility.

    Product
    Pau D'Arco Bark C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2331-2012·2012-09-26

    Somersaults Crunchy Nuggets Recalled for Undeclared Milk Allergen

    Somersault Snack Co. is recalling Crunchy Nuggets because some packages contained Santa Fe Salsa crackers with undeclared milk protein.

    Product
    Somersaults Crunchy Nuggets baked with sunflower seed and toasted grains. Pacific Sea Salt Flavor, Net Wt. 6 oz. UPC 8-98403 00201-7;
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-2384-2012·2012-09-26

    Philips DigitalDiagnost Systems Recalled for Electrical Safety Standard Non-Compliance

    Philips Healthcare Inc. is recalling four DigitalDiagnost Systems because the GEO Transformer does not meet international electrical safety standards.

    Product
    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2400-2012·2012-09-26

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Missing Seals

    Vascular Solutions, Inc. is recalling Guardian II Hemostasis Valves because some pouches are missing a seal, posing a risk of product contamination.

    Product
    Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve, Model FH102. Intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2307-2012·2012-09-26

    Paprika Sweet Powder Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Paprika Sweet Powder after inspectors found a pervasive mouse infestation in the facility.

    Product
    Paprika Sweet Powder; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2422-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 1,536 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2428-2012·2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2427-2012·2012-09-26

    Smith & Nephew Recalls 70 Undersized Modular Hip Neck Components

    Smith & Nephew is recalling 70 modular hip neck components because the taper is undersized due to manufacturing errors.

    Product
    12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 analyzers because they may report abnormal fibrinogen levels as normal or low levels as high.

    Product
    Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thromb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2012·2012-09-26

    Integra HRAIM Head Ring Assembly Recalled for T-Handle Seating Issue

    Integra LifeSciences is recalling HRAIM Head Ring Assemblies because a T-handle screw may prevent the CRW stereotactic system from seating properly.

    Product
    Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2418-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 55,632 REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2421-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2402-2012·2012-09-26

    Steris Surgical Table Recalled for Potential Unintended Movement

    Steris Corporation is recalling 11,044 surgical tables because prohibited storage of objects on the base or column can damage the override switch, potentially causing the table to move without operator prompting.

    Product
    A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible general surgical table. Product Usage: Product provides a flexible, easy-to-use, articulated posturing of a patient for either general, I.A., or specialized surgical procedures. There are movable compon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2338-2012·2012-09-26

    F&S Produce Recalls Fresh-Cut Mangoes Due to Salmonella Risk

    F&S Produce is voluntarily recalling expired Delish Tropical Medley fresh-cut mangoes because related Daniella brand mangoes may be contaminated with Salmonella.

    Product
    Delish Tropical Medley 10 oz.(283 g) Enjoy by: 8/28/12 and before Distributed by: Walgreen Co. 200 Wilmot Road, Deerfield, IL 60015 Distributed by Walgreens UPC 04 902253699 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2358-2012·2012-09-26

    Custom Medical Specialties Recalls HSG Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-4975 HSG Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet specifications.

    Product
    CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of throm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2392-2012·2012-09-26

    Instrumentation Laboratory ACL TOP 700 CTS Recalled for Fibrinogen Test Errors

    Instrumentation Laboratory is recalling ACL TOP 700 CTS analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2012·2012-09-26

    Elekta Precise Digital Accelerator Recall Due to Loose Drive Gear Joint

    Elekta is recalling 110 Precise Digital Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Precise Digital Accelerator Delivery of radiation to defined target volumes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2012·2012-09-26

    Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2387-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Testing Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may report abnormal fibrinogen levels as normal or vice versa, potentially affecting clinical decisions.

    Product
    Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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