The Recall Desk

Archive

September 2012 recalls

607 recalls were announced in September 2012.

What the numbers show

Critical
135
Severe
187
High
184
Moderate
76
Low
25

Of the 607 recalls this month scored against our rubric, 22% are Critical, 31% are Severe.

Which agencies issued them

301–400 of 607

  • SevereFDA (Food)·F-2163-2012·2012-09-19

    Whole Foods Florida Recalls Prepared Foods for Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods and seafood items that may contain raw yellow onions from Gill Onions, LLC due to possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. TOFU JAPONAISE
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2215-2012·2012-09-19

    Garden-Fresh Egg Salad Spread Recalled for Listeria Risk

    Garden-Fresh Foods is recalling specific lots of egg salad spread because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Egg Salad Spreads: 1) Garden-Fresh Egg Salad Spread, 5 lbs., 0 11596 52053 7; 2) Finest Traditions Egg Salad Spread, 12 oz., 7 33147 10491 0 & 4 lbs., 10 733147 10189
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2155-2012·2012-09-19

    Whole Foods Florida Recalls Chicken Salad Rolls for Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods, including chicken salad rolls, due to possible Listeria monocytogenes contamination from raw yellow onions.

    Product
    The Thousand Island Chicken Salad Roll is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***1000 ISLAND CHICKEN SALAD ROLL 2 FOR 5***BREAD ( UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2182-2012·2012-09-19

    Garden-Fresh Foods Recalls Smoked Imitation Salmon Due to Listeria Risk

    Garden-Fresh Foods is recalling specific lots of Finest Traditions Smoked Imitation Salmon because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Smoked Imitation Salmon, 12 oz., 7 33147 00127 1; 8 lbs., 10 733147 10120 6
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2168-2012·2012-09-19

    Garden-Fresh Foods Recalls Smokey Baked Beans Due to Listeria Risk

    Garden-Fresh Foods is recalling specific lots of Finest Traditions Smokey Baked Beans because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Smokey Baked Beans, 8 lbs.,10 733147 10456 6, 16 oz., 7 33147 00161 5, 8 lbs., 10 733147 10231 9;
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2288-2012·2012-09-19

    Missa Bay Recalls Wawa Turkey and Cheese Sandwiches for Listeria Contamination

    Missa Bay, LLC is recalling Wawa turkey and cheese sandwiches due to contamination with Listeria monocytogenes. The recall covers 264,662 cases and 296,224 units distributed across 37 states.

    Product
    Wawa turkey & cheese sandwich Net Wt 7.7 OZ (219g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905622
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-2290-2012·2012-09-19

    Wegmans Apples, Cheese & Caramel Dip Recalled for Listeria Contamination

    Missa Bay, LLC is recalling Wegmans Apples, Cheese & Caramel Dip due to Listeria monocytogenes contamination. Consumers should check for the specific UPC and use-by date.

    Product
    Wegmans Apples, Cheese & Caramel Dip, 4 OZ (113g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 15; UPC 7789026743
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-2174-2012·2012-09-19

    Archer Farms Taco Dip Kits Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Archer Farms Layered Taco Dip Kits because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Archer Farms Layered Taco Dip Kits - Taco Dip, kit, 0 11 11596 36300 4
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2242-2012·2012-09-19

    Garden-Fresh Foods Recalls Blue Cheese Potato Salad for Listeria Risk

    Garden-Fresh Foods is recalling Finest Traditions Blue Cheese Potato Salad because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Blue Cheese Potato Salad, 8 lb., 10 733147 10137 4
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2144-2012·2012-09-19

    Whole Foods Florida Recalls Fresh Foods Due to Listeria Risk

    Whole Foods Market in Florida is recalling fresh prepared and seafood items that may contain raw yellow onions from a supplier recalled for possible Listeria monocytogenes contamination.

    Product
    Ranch Dressing No Oil Added sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***RANCH DRESSING NO OIL ADDED***TOFU ( WATER, SOYBEANS, ISOLATED SOY PROTEIN, GLUCONOLACTONE & CALCIUM CHLORIDE), OAT MILK…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2266-2012·2012-09-19

    Missa Bay Recalls McDonald's Apple Slices Due to Listeria Contamination

    Missa Bay, LLC is recalling McDonald's apple slices contaminated with Listeria monocytogenes. The recall covers 264,662 cases and 296,224 individual units distributed across 35 states and DC.

    Product
    McDonalds M Apple Slices Net Wt 1.2 oz (34g) On or before August 19; no upc code
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-2181-2012·2012-09-19

    Garden-Fresh Tomato Mozzarella Salad Kit Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Tomato Mozzarella Salad Kits because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Tomato Mozzarella Salad Kit 4 lbs. 0 11596 55163 0
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2284-2012·2012-09-19

    Missa Bay Recalls Wawa Chicken Salad Sandwiches for Listeria Contamination

    Missa Bay, LLC is recalling Wawa Chicken Salad Sandwiches due to contamination with Listeria monocytogenes. The affected products were distributed across 36 states and Washington, D.C.

    Product
    21) Wawa Chicken salad sandwich Net Wt. 7.8 OZ (221g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 10; UPC 261905670
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-2176-2012·2012-09-19

    Garden-Fresh German Potato Salads Recalled for Listeria Risk

    Garden-Fresh Foods is recalling specific German Potato Salads because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    German Potato Salads packaged under the following brand, dip name, container size, and UPC number: 1. Copperwood Kitchens German Potato Salad, 5 lbs., 8 11839 01033 3; 2. Garden-Fresh German Potato Salad, 16 oz., 0 11596 14017 9 ,3 lbs., 0 11596 34319 8 , 5 lbs., 0…
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2206-2012·2012-09-19

    Garden-Fresh Creamy Cheddar Macaroni Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Creamy Cheddar Macaroni because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Creamy Cheddar Macaroni , 8 lbs., 10 733147 10156 5
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2138-2012·2012-09-19

    Whole Foods Florida Recalls Cranberry Tuna Salad Rolls Due to Listeria Risk

    Whole Foods Market in Florida is recalling fresh food items, including Cranberry Tuna Salad Rolls, because they may contain raw yellow onions contaminated with Listeria monocytogenes.

    Product
    Cranberry Tuna Salad Roll sold at the chef's case, self service bar, or packaged. Packaged product is labeled as listed below: "WHOLE FOODS MARKET***CRANBERRY TUNA SALAD ROLL 2 FOR 5***BREAD (UNBLEACHED UNBROMATED WHEAT OR WHOLE WHEAT FLOUR, WATER, FLORIDA CRYSTALS SUGAR…
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·12V464000·2012-09-19

    Suzuki Recalls 2012 Equator Vehicles Due to Front Wheel Hub Defect

    Suzuki is recalling 2012 Equator two-wheel drive vehicles because front wheel hubs may not meet hardness specifications, potentially leading to cracks and loss of vehicle control.

    Product
    SUZUKI — SUZUKI EQUATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2190-2012·2012-09-19

    Garden-Fresh Black Bean Salsa Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Black Bean Salsa because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Black Bean Salsa, 15 oz., 0 11596 06118 4 Garden-Fresh Black Bean Salsa, 5 lbs., 0 11596 52587 7
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2210-2012·2012-09-19

    Garden-Fresh Macaroni Salads Recalled for Potential Listeria Contamination

    Garden-Fresh Foods is recalling specific macaroni salad products due to potential Listeria monocytogenes contamination from onions.

    Product
    Macaroni Salads: 1) Garden-Fresh Macaroni Salad, 0 11596 14018 6, 16 oz., 4018, 0 11596 52005 6, 5 lbs., 20050 11596 34305 1, 3 lbs., 4305, 0 11596 24210 1, 2 lbs., 4210 2) Spartan Macaroni Salad 11213903262 3 lbs 4373 11213903217 16 oz 4073 3) Finest Traditions…
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2233-2012·2012-09-19

    Garden-Fresh Potato Salads Recalled for Potential Listeria Contamination

    Garden-Fresh Foods is recalling specific potato salad products due to potential Listeria monocytogenes contamination from onions supplied by Gills Onions.

    Product
    Potato Salad with Egg: 1) Acme Homestyle Egg Potato Salad, 16 oz. 0 11596 14005 3; 2) Weis Potato w/ Egg Salad, 16 oz., 0 41497 05841 9, 3 lb., 0 41497 05902 7, 5 lb., 0 11596 51101 6
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2214-2012·2012-09-19

    Garden-Fresh Egg Salads Recalled for Potential Listeria Contamination

    Garden-Fresh Foods is recalling specific egg salad products due to potential Listeria monocytogenes contamination from onions supplied by Gills Onions.

    Product
    Egg Salads: Garden-Fresh Egg Salad, 5 lbs., 0 11596 52022 3 & 5 lbs., 0 11596 52053 Weis Egg Salad, 8 oz., 0 41497 05365 0 & 5 lbs., 0 11596 55221 7
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2287-2012·2012-09-19

    Missa Bay Recalls Wawa Red Grapes Due to Listeria Contamination

    Missa Bay, LLC is recalling Wawa red grapes contaminated with Listeria monocytogenes. Consumers should discard the product.

    Product
    Wawa red grapes Net Wt 3 OZ (85g) Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 13; UPC 2619102518
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-2223-2012·2012-09-19

    Garden-Fresh Amish Country Cole Slaw Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Amish Country Cole Slaw because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Amish Country Cole Slaw, 5 lbs., 0 11596 53010 9;
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2194-2012·2012-09-19

    Garden-Fresh Greek Style Pasta Salad Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Greek Style Pasta Salad products due to potential Listeria monocytogenes contamination in onions.

    Product
    Copperwood Kitchens Greek Style Pasta Salad 5 lbs. 8 11839 01032 6 Garden-Fresh Greek Style Pasta Salad 5 lbs. 0 11596 52035 3
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2150-2012·2012-09-19

    Whole Foods Florida Recalls Fresh Foods for Listeria Risk

    Whole Foods Market in Florida is recalling fresh prepared and seafood items that may contain raw yellow onions contaminated with Listeria monocytogenes.

    Product
    The Shrimp Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***SHRIMP SALAD SANDWICH***SHRIMP, CANOLA MAYONNAISE ( CANOLA OIL, EGGS, FILTERED WATER, HONEY, VINEGAR, SEA SALT, DRY…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2254-2012·2012-09-19

    Garden-Fresh Foods Recalls Deviled Egg Potato Salads Due to Listeria Risk

    Garden-Fresh Foods is recalling specific deviled egg potato salads because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Deviled Egg Potato Salads: ) Grandpas Deviled Egg Potato Salad, 1 lb., 0 11596 14012 4; 5 lb., 0 11596 51065 1; 3.5 oz., 0 11596 08005 5; 2) Copperwood Kitchens Deviled Egg Potato Salad, 00295
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-2156-2012·2012-09-19

    Whole Foods Florida Recalls Chicken Salad Sandwiches for Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods and seafood items that may contain raw yellow onions from Gill Onions, LLC, due to possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The Thousand Island Chicken Salad Sandwich is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***THOUSAND ISLAND CHICKEN SALAD SANDWICH***CHICKEN (…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2195-2012·2012-09-19

    Garden-Fresh Foods Recalls Bow Tie Pastas Due to Listeria Risk

    Garden-Fresh Foods is recalling two types of 5-lb bow tie pastas because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Bow Tie Pastas: 1) Copperwood Kitchens Venetian Bow Tie Pasta, 5 lbs., 8 11839 01031 9; 2) Garden-Fresh Venetian Bowtie Pasta, 5 lbs., 0 11596 520278
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2330-2012·2012-09-19

    Custom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing

    Custom Medical Specialties is recalling PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.

    Product
    CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2339-2012·2012-09-19

    Intuitive Surgical Recalls Tip Covers for Monopolar Curved Scissors

    Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.

    Product
    Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recall

    Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2327-2012·2012-09-19

    Bard Foley procedural trays recalled due to incomplete sterile seals

    C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.

    Product
    Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Sterility Issues

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2344-2012·2012-09-19

    Medtronic Recalls NIM 3.0 Patient Interfaces Due to Signal Loss

    Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2346-2012·2012-09-19

    Hospira Recalls Sterile Empty Vials Due to Leaking During Filling

    Hospira is recalling sterile empty vials and injectors because they may leak during filling and administration. The recall covers products distributed in the US, Canada, Costa Rica, and the Virgin Islands.

    Product
    Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2371-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Modular Tibia Augments

    Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2012·2012-09-19

    Biosense Webster Recalls CARTO 3 Mapping System Due to Stimulator Hazard

    Biosense Webster is recalling 71 CARTO 3 V1.05 systems because a potential hazard may occur when used with Bloom EP Stimulators and other electrophysiology equipment.

    Product
    CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2012·2012-09-19

    Custom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing

    Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods specifications.

    Product
    CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2331-2012·2012-09-19

    Custom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing

    Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.

    Product
    CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2375-2012·2012-09-19

    Omnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2012·2012-09-19

    Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss

    Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2348-2012·2012-09-19

    Terumo Sarns Modular Perfusion System 8000 Safety Monitor Recall

    Terumo is recalling eight Sarns Modular Perfusion System 8000 safety monitors due to an underrated circuit breaker that may cause the device to trip off.

    Product
    Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2342-2012·2012-09-19

    Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss

    Medtronic is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss and potential surgical delays.

    Product
    Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns

    Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2334-2012·2012-09-19

    JK Products Recalls Sun|Dash Radius 252 Tanning Systems Due to Wiring Short

    JK Products & Services is recalling 1,948 Sun|Dash Radius 252 tanning systems because a door cord failure can cause a short in the wiring.

    Product
    SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2012·2012-09-19

    Omni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach

    Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2333-2012·2012-09-19

    Aesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect

    Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.

    Product
    Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2256-2012·2012-09-19

    GE Healthcare Recalls Optima XR200amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2012·2012-09-19

    Capsule Neuron Docking Station Recalled for Potential Connection Loss

    Capsule Tech Inc. is recalling 12,448 Capsule Neuron Docking Stations because they may lose connection, causing data loss or power interruption to the bedside device.

    Product
    Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2012·2012-09-19

    Custom Medical Specialties Recalls CMS-2890 Needle Local Trays

    Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.

    Product
    CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2012·2012-09-19

    GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue

    GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.

    Product
    Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2012·2012-09-19

    Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition

    Exactech is recalling two Novation Modular Drill Bits after they were reported to have been used in a non-sterile condition.

    Product
    REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2292-2012·2012-09-19

    Atlas Operations Recalls foru Meal Replacement for Microbial Contamination

    Atlas Operations, Inc. is recalling 425 bottles of foru Meal Replacement dietary supplement due to possible microbial contamination.

    Product
    Meal Replacement product is labeled in part: "***The Perfect Shake***All of the Best***None of the Rest***foru***Dietary supplement***Net wt. 20 oz (1 lb 4 oz) (564 g)***A well balanced blend of old-world plant nutrition.***What's in The Perfect Shake supplement? All of the…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2370-2012·2012-09-19

    Omni Life Science Recalls Apex Knee System Tibia Augments

    Omni Life Science is recalling 312 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.

    Product
    Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F2225-2012·2012-09-19

    Thai Farmer Brand Preserved Star Gooseberry Recalled for Undeclared Dye

    T.F. Foods Incorporated is recalling Thai Farmer Brand Preserved Star Gooseberry because it contains undeclared FD&C Yellow #6.

    Product
    Thai Farmer Brand Preserved Star Gooseberry, NET WT 7.0 OZ. Packaged 30 per case. Product labeling reads in part:"***THAI FARMER BRAND PRESERVED STAR GOOSEBERRY*** DISTRIBUTED BY: T.F. FOODS, INC. PARAMOUNT, CA 90723***NET WT. 7.0 OZ***PRODUCT OF THAILAND***".
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2376-2012·2012-09-19

    GE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems

    GE Healthcare is recalling Innova 2121IQ and 3131IQ systems due to a potential loss of imaging mode requiring a restart.

    Product
    GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and…
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2345-2012·2012-09-19

    Volcano Intravascular Ultrasound Software Recall Due to Display Changes

    Volcano Corporation is recalling specific Intravascular Ultrasound software versions because the system display may change unexpectedly. The issue requires a unique sequence of events to occur.

    Product
    Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3.2.2, Models/Part Numbers: 435-0607.01, 435-0607.04, 435-0602.01, 435-0602.02; Product is manufactured and distributed by Volcano Corporation, Rancho Cordova, CA. Medical device for use…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2368-2012·2012-09-19

    Lucero Medical Recalls Enduramesh Spacers Due to Sterilization Validation Failure

    Lucero Medical LLC is voluntarily recalling 169 Enduramesh Corpectomy Spacer Systems because the sterilization recommendations on the product insert did not pass sterilization validation.

    Product
    Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2332-2012·2012-09-19

    Sunquest Laboratory Software Recalled for Patient Data Merge Errors

    Sunquest Information Systems is recalling specific versions of its Laboratory software because a merge function may cause receiving systems to incorrectly merge patient data.

    Product
    Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2340-2012·2012-09-19

    Elekta Agility Multileaf Collimator Recall for Missing Compatibility Information

    Elekta is recalling two Agility Multileaf Collimators because the original product information did not specify compatibility with the Dynamic Multileaf Collimator Apex add-on.

    Product
    Multileaf Collimator To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2367-2012·2012-09-19

    Siemens Mobilett Mira Mobile X-Ray System Recalled for Wheel Defect

    Siemens is recalling nine Mobilett Mira mobile x-ray systems because a loose center screw on the driving wheel may cause the system to become immobilized.

    Product
    Siemens Mobilett Mira mobile x-ray system Product Usage: Mobile x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2338-2012·2012-09-19

    Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Printing Verification Failure

    Advanced Sterilization Products is recalling STERRAD NX cassettes because the camera used to verify printing was disabled, resulting in unverified product labels.

    Product
    STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2296-2012·2012-09-19

    Meijer Brand Mushrooms Recalled for Sodium Labeling Error

    Meijer Distribution, Inc. is recalling Meijer Brand Mushrooms because the sodium content is above the declared value on the label.

    Product
    Meijer Brand Mushrooms, imported from The Netherlands Stems & Pieces, DR WT 4-oz and 8-oz sizes/Net Wt. 6.5-oz and 13.25-oz, UPC 7-1373337545-0 and UPC 7-1373337544-3
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-2337-2012·2012-09-19

    Advanced Sterilization Products Recalls STERRAD 100S and NX Cassettes

    Advanced Sterilization Products is recalling STERRAD 100S and NX cassettes because a camera used to verify printing was disabled, resulting in unverified product labels.

    Product
    STERRAD 100S Cassette, Batch # 12A077. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2336-2012·2012-09-19

    Helix Medical Recalls Blom-Singer Occluder for Invalid Expiration Date

    Helix Medical LLC is recalling the Blom-Singer indwelling TEP Occluder due to an invalid expiration date. The recall covers devices distributed in the US and UK.

    Product
    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V456000·2012-09-18

    Altec Aerial Vehicles Recalled for Outrigger Cylinder Torque Defect

    Altec is recalling 2002-2009 aerial vehicles because improperly torqued outrigger cylinders could loosen, posing a risk of injury or property damage.

    Product
    ALTEC — ALTEC AH100, AH75, HL125, AH85
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V457000·2012-09-18

    Polaris Recalls 2012-2013 Victory Motorcycles Due to Throttle Cable Nut Defect

    Polaris is recalling 2012-2013 Victory motorcycles because throttle cable retention nuts may not have been torqued correctly, which could interfere with throttle function and increase crash risk.

    Product
    VICTORY — VICTORY BOARDWALK, JUDGE, CROSS COUNTRY, JACKPOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V458000·2012-09-18

    Forest River Recalls 2010-2013 Motorhomes Due to LPG Fuel Line Defect

    Forest River is recalling 2010-2013 Sunseeker, Forester, and Lexington motorhomes because a damaged liquid propane gas fuel line can cause fire or explosion.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, LEXINGTON, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V460000·2012-09-18

    GM Recalls 2007-2010 Saturn, Pontiac, Chevrolet Models for Shift Cable Defect

    General Motors is recalling specific 2007-2010 Saturn Aura, Pontiac G6, and Chevrolet Malibu vehicles because a transmission shift cable defect could allow the car to roll away.

    Product
    SATURN — SATURN, PONTIAC, CHEVROLET AURA, G6, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12279·2012-09-18

    H&M Recalls Children's Water Bottles Due to Choking Hazard

    H&M is recalling about 2,900 children's water bottles sold in the U.S. because the spout can break off, posing a choking hazard.

    Product
    Children's Water Bottle
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V455000·2012-09-17

    Zero Motorcycles Recalls 2012 S and DS Models for Power Loss Risk

    Zero Motorcycles is recalling 2012 S and DS motorcycles because a motor encoder signal may drift, causing the motor controller to shut off and resulting in a loss of power.

    Product
    ZERO — ZERO ZERO DS, ZERO S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V454000·2012-09-17

    GM Recalls 2013 Chevrolet Sonic for Turn Signal Detection Failure

    General Motors is recalling 2013 Chevrolet Sonic vehicles because the Body Control Module may fail to detect a broken turn signal lamp, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V451000·2012-09-14

    Jayco Recalls Motorhomes and Trailers Due to Electrical Fire Risk

    Jayco is recalling specific 2008-2011 motorhomes and travel trailers because a defective transfer switch may overheat and cause a fire.

    Product
    JAYCO — JAYCO MELBOURNE CLASS C, GREYHAWK CLASS C, OCTANE SPORT UTILITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V450000·2012-09-13

    Prevost Recalls 2009-2013 Volvo Bus 9700 Coaches for Fire Risk

    Prevost is recalling 2009-2013 Volvo Bus 9700 coaches because a cracked hydraulic pipe may spray oil on hot engine parts, causing a fire.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V447000·2012-09-13

    Daimler Orion Transit Buses Recalled for Turbocharger Failure Risk

    Daimler Buses North America is recalling certain Orion V and VII transit buses because a turbocharger component may fail, potentially causing smoke, fire, or stalling.

    Product
    ORION — ORION V, VII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V449000·2012-09-13

    Mobility Services Recalls Ford E-Series Vans with Wheelchair Lifts

    Mobility Services is recalling 2006-2010 Ford E-150, E-250, and E-350 vans equipped with specific wheelchair lifts because roll stop latches may fail, posing a fall risk.

    Product
    MOBILITY SERVICES — MOBILITY SERVICES FORD E-150, FORD E-250, FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12276·2012-09-13

    True Innovations Recalls Prestigio Office Chairs Due to Seat Plate Breakage

    True Innovations is recalling about 8,400 Prestigio office chairs because the seat plate can break, posing a fall hazard. Consumers should stop using the chairs and contact the company for a repair kit.

    Product
    Realspace Soho Prestigio High-Back Leather Chair
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2117-2012·2012-09-12

    Trader Joe's Balela salad recalled due to Listeria monocytogenes contamination

    Simmering Soups Inc. is recalling Trader Joe's Balela salad because onions in the product were found to be contaminated with Listeria monocytogenes.

    Product
    Trader Joe's, Balela (A savory Middle Eastern salad with chickpeas, black beans and tomatoes). 8 ounces (227g). in clear rigid plastic containers with snap on lids.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2116-2012·2012-09-12

    Trader Joe's Mild Salsa Recalled Due to Listeria Contamination

    Simmering Soups Inc. is recalling Trader Joe's Mild Salsa because onions in the product were found to be contaminated with Listeria monocytogenes.

    Product
    Trader Jose's, Mild Salsa, 16 ounce (1 lb) 454g), in clear rigid plastic containers with snap on lids.
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2114-2012·2012-09-12

    Safeway Farms White Sliced Mushrooms Recalled for Listeria Risk

    Safeway Inc. is recalling 8 oz packages of Safeway Farms White Sliced Mushrooms due to potential Listeria monocytogenes contamination.

    Product
    "SAFEWAY farms White Sliced Mushrooms***DISTRIBUTED BY SAFEWAY INC.***PLEASATON, CA***PRODUCT OF CANADA***NET WT 8 OZ (227g)" UPC 0 21130 28443 6
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-2115-2012·2012-09-12

    Dole Sliced Mushrooms Recalled for Potential Listeria Contamination

    United Salad Company is recalling Dole 8 oz Sliced Mushrooms due to potential Listeria monocytogenes contamination. The product was distributed in Idaho, Oregon, and Washington.

    Product
    Dole Mushroom, packaged in a retail package, net wt. 8 oz. The UPC is 0 33383 67600 5.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·12V452000·2012-09-12

    Geo. Heiser Body Recalls Battery Separator Devices on Commercial Trucks

    Geo. Heiser Body Company is recalling specific commercial trucks equipped with Sure Power battery separator devices that may overheat, causing smoke or fire.

    Product
    PETERBILT — PETERBILT, KENWORTH, FUSO 337, T270, FE160, T271
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2250-2012·2012-09-12

    Newport HT70 Ventilators Recalled for Control Board Failure Risk

    Newport Medical Instruments is recalling 72 HT70 and HT70 Plus ventilators because a control board failure may cause the device to stop ventilating.

    Product
    Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2131-2012·2012-09-12

    Fresh Express Romaine Lettuce Recalled for Listeria Monocytogenes Contamination

    Fresh Express is recalling specific bags of Hearts of Romaine lettuce after FDA testing found Listeria Monocytogenes. Consumers should discard the product.

    Product
    Fresh Express Hearts of Romaine Crunchy and Sweet 100% Hearts of Romaine Lettuce. 10 oz. plastic bag UPC 71279 26102. Fresh Express, Salinas, CA.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2260-2012·2012-09-12

    Respironics Recalls V60 Ventilators Due to Blower Motor Assembly Defect

    Respironics is recalling V60 ventilators because blower motor assemblies may not meet specifications, potentially causing the device to stop delivering therapy.

    Product
    V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2128-2012·2012-09-12

    Atlantic Fisheries Recalls Fresh Mahi Mahi Fillets Due to High Histamine Levels

    Atlantic Fisheries is recalling 580 lbs of fresh Mahi Mahi fillets because histamine levels exceeded 50 ppm. The product was distributed to Winn Dixie in Florida, Alabama, and Louisiana.

    Product
    Fresh Mahi Mahi Fillets,10 lb Styrofoam case, labeled in part: "***Mahi Fillets S/ON Costa Rica Wild****KEEP AT 38 OR BELOW Keep refrigerated***ATLANTIC FISHERIES 8195 NW 67TH ST MIAMI FLORIDA 33166***TEL***FAX 305-594-4301***PACK U.S.A.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2113-2012·2012-09-12

    Vauxner-USA Recalls Flavored Cheddar Cheese Due to Listeria Risk

    Vauxner-USA, LLC is recalling specific lots of flavored cheddar cheese because the product may be contaminated with Listeria monocytogenes.

    Product
    Flavored cheddar cheese, vacuum packed in weights ranging from 0.25-0.50 pounds, labeled and batch coded by firm. Cheese labeled in part: "Medium Cheddar Red Pepper with Onion & Garlic Pasteurized whole milk, salt, culture, vegetable rennet, spices. r-BST free.***GOLDEN GLEN…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2311-2012·2012-09-12

    Trumpf Acrobat 3000 Spring Arm Recalled for Welded Seam Cracks

    Trumpf Medical Systems is recalling Acrobat 3000 spring arms for iLED operating lights because cracks can form on the welded seam at the rear joint.

    Product
    Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·12V445000·2012-09-12

    Triumph Recalls 2006-2009 Motorcycles Due to Regulator Overheating Risk

    Triumph is recalling 2006-2009 Street Triple and Daytona 675 motorcycles because the regulator/rectifier can overheat, potentially causing the bike to stall and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH DAYTONA 675, STREET TRIPLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2012·2012-09-12

    AmeriWater MRO Dialysis Systems Recalled Due to Incorrect Fuse Installation

    AmeriWater Inc is recalling 80 MRO Dialysis RO+ Systems because incorrect fuses were installed, which may cause excessive heat and device failure.

    Product
    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2132-2012·2012-09-12

    Humphrey Candy Kisses Recalled for Undeclared Milk Allergen

    The Humphrey Popcorn Co is voluntarily recalling Candy Kisses because the label fails to declare milk, a major food allergen.

    Product
    Humphrey Candy Kisses, 4 oz. individually wrapped and contained in a clear plastic bag, UPC Code 81084 00002. Bags are packed 40 to a case.
    Category
    Food
    Distribution
    4 states

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