The Recall Desk

Archive

October 2012 recalls

969 recalls were announced in October 2012.

What the numbers show

Critical
242
Severe
210
High
389
Moderate
113
Low
15

Of the 969 recalls this month scored against our rubric, 25% are Critical, 22% are Severe.

901–969 of 969

  • HighFDA (Food)·F-2376-2012·2012-10-03

    Triton Seafood Recalls Neptune Conch Fritters Due to Missing Wheat Allergen Labeling

    Triton Seafood Co. is recalling Neptune brand frozen Pre-cooked Conch Fritters and Conch Fritter Batter because the allergen wheat was not identified on the product label.

    Product
    Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2415-2012·2012-10-03

    McClure's Banana Cream Pie Recalled for Undeclared Wheat Allergen

    McClure's Banana Cream Pie is being recalled because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Banana Cream Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2470-2012·2012-10-03

    Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit

    Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.

    Product
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Const
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Universal Light Source Devices

    ConMed Linvatec is recalling 57 Xenon Universal Light Source units used for endoscopic illumination due to a Class II recall.

    Product
    ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2401-2012·2012-10-03

    McClure's Chocolate Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling 96 chocolate cakes because the ingredient list says 'flour' without specifying wheat, a major allergen.

    Product
    McClure's Pies & Salads, Inc. Chocolate Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2402-2012·2012-10-03

    McClure's Red Velvet Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads is recalling 31 Red Velvet Cakes because the ingredient list says 'flour' without specifying wheat, posing a risk to those with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Red Velvet Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2373-2012·2012-10-03

    Haldeman Mills Recalls Yellow Corn Meal for Fumonisin Contamination

    Haldeman Mills is recalling specific 25 lb and 50 lb bags of Bulk Foods Yellow Corn Meal because FDA samples tested positive for Fumonisin.

    Product
    Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2416-2012·2012-10-03

    McClure's Cherry Custard Pie Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling Cherry Custard Pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to consumers with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Cherry Custard Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2463-2012·2012-10-03

    DEXIS Imaging Suite Software Recall for Patient Data Mixing

    Imaging Sciences International is recalling DEXIS Imaging Suite software versions 10.0.0 through 10.0.3 due to a defect that can mix patient records during database renumbering.

    Product
    DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2451-2012·2012-10-03

    Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure

    Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.

    Product
    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images o
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-2406-2012·2012-10-03

    McClure's Lemon Glazed Cake Recalled for Undeclared Allergens

    McClure's Pies & Salads, Inc. is recalling 156 Lemon Glazed Cakes because the ingredient statement does not list Yellow #5, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Lemon Glazed Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2380-2012·2012-10-03

    Ready Pac Fruit Tray Recalled for Potential Salmonella Contamination

    Ready Pac Foods is voluntarily recalling specific fruit trays containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Ready Pac¿ Fruit Tray Bien¿, 907g UPC 7774523415 and Use by date 9/8/2012. Ready Pac¿ Fruit Tray Bien¿ 32oz UPC 7774521606, Use by date 9/8/2012 or earlier.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2372-2012·2012-10-03

    Meijer Walnuts Recalled Due to Unlabeled Pecans

    Meijer Distribution is recalling 16-ounce bags of walnuts because some contain unlabeled pecans, a potential allergen.

    Product
    Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2428-2012·2012-10-03

    McClure's Egg Salad Recalled for Undeclared Allergens in Mayonnaise

    McClure's Pies & Salads, Inc. is recalling 3 lbs Egg Salad because the ingredient list mentions mayonnaise but fails to list its sub-ingredients, posing an undeclared allergen risk.

    Product
    McClure's Pies & Salads, Inc. Egg Salad
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2399-2012·2012-10-03

    McClure's Marble Cake Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling 15 Marble Cakes because the ingredient list says 'flour' instead of specifying wheat flour, posing a risk to those with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Marble Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2469-2012·2012-10-03

    ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets

    ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.

    Product
    Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2012·2012-10-03

    Toshiba Aquilion One CT System Recalled for Abnormal Analysis Results

    Toshiba American Medical Systems is recalling three Aquilion One CT systems because the SureStart function may fail, leading to abnormal cerebral blood flow analysis results.

    Product
    TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2408-2012·2012-10-03

    McClure's Apple Dumplings Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Apple Dumplings because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Apple Dumplings
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2400-2012·2012-10-03

    McClure's German Chocolate Cake Recalled for Undeclared Wheat Allergen

    McClure's German Chocolate Cake is being recalled because the ingredient list says 'flour' without specifying wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. German Chocolate Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2449-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Module Recalled for Display Malfunction

    Terumo is recalling 72 Flow Modules for the Advanced Perfusion System 1 because they may fail to display blood flow information or illuminate the LED indicator.

    Product
    Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1691-2012·2012-10-03

    Dispensing Solutions Recalls Atrovent HFA Inhalers Due to Label Error

    Dispensing Solutions, Inc. is recalling 18 Atrovent HFA inhalers because a sticker label incorrectly identifies the product as Ventolin HFA.

    Product
    Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-2435-2012·2012-10-03

    Pulmuone Wildwood Organic Hot Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 3,148 units of Wildwood Emerald Valley Kitchen Organic Hot Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Hot Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC HOT SALSA***NET WT. 14 OZ (850g)***MANUFACTURED BY
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2437-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage Concerns

    Pulmuone Wildwood Inc. is recalling 781 units of Wildwood Emerald Valley Kitchen Organic Mild Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Mild Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2433-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc is recalling Wildwood Emerald Valley Kitchen Organic Medium Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2447-2012·2012-10-03

    Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter

    Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.

    Product
    Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM CATH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2439-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc is recalling 748 units of Wildwood Organic Medium Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Organic Medium Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***"
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2455-2012·2012-10-03

    ConMed Linvatec Recalls Xenon Light Sources for Endoscopic Procedures

    ConMed Linvatec is recalling LS7700 and LS7600 Xenon Light Sources used to illuminate endoscopes during medical procedures.

    Product
    ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2438-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage Concerns

    Pulmuone Wildwood Inc is recalling 602 units of Wildwood Organic Mild Salsa due to a potential non-safety quality concern involving an ingredient that causes premature spoilage.

    Product
    Wildwood Organic Mild Salsa , 14 oz, Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD ORGANIC salsa MILD ***NET WT. 14OZ, MANUFACTURED BY PULMUONE FOODS USA, Inc. Fullerton, CA 92833***".
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1687-2012·2012-10-03

    Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2457-2012·2012-10-03

    Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads

    Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.

    Product
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1695-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Container Wall Defect

    Abbott Laboratories is recalling 42,596 bottles of Synthroid (levothyroxine sodium) 75 mcg tablets due to a localized thin wall defect on the bottle bottom that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Recalled for Flipped DICOM Images

    Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2446-2012·2012-10-03

    Applied Medical Recalls Vascular Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of Vascular Catheters because packaging particulate matter may reside on the product.

    Product
    Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2434-2012·2012-10-03

    Pulmuone Wildwood Organic Mild Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 21,841 units of Wildwood Emerald Valley Kitchen Organic Mild Salsa due to a non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Mild Salsa, 14 oz. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MILD SALSA***NET WT. 14 OZ (850g)***MANUFACTURED
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1690-2012·2012-10-03

    Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

    Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1701-2012·2012-10-03

    Glenmark Recalls Naproxen Sodium Tablets Due to Labeling Error

    Glenmark Generics is recalling Naproxen Sodium 500 mg tablets because some bottles may contain Pravastatin Sodium 40 mg tablets.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2012·2012-10-03

    Applied Medical Recalls Irrigation Catheters Due to Packaging Particulate Matter

    Applied Medical Resources Corp is recalling specific lots of irrigation catheters because packaging particulate matter may reside on the product.

    Product
    Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral vascul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2453-2012·2012-10-03

    Hologic Fluoroscan Mini C-Arm Software Recall for Image Orientation Errors

    Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.

    Product
    Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1694-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 53,448 bottles of Synthroid (levothyroxine sodium) 50 mcg tablets nationwide due to a defect in the bottle bottom that may affect tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2467-2012·2012-10-03

    K-Y Liquibeads Vaginal Moisturizer Recalled for Regulatory Compliance

    Johnson & Johnson is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns regarding the product's medical device clearance status.

    Product
    KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2444-2012·2012-10-03

    RaySearch SharePlan Software Recalled for Unexpected Import Behavior

    RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.

    Product
    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2471-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters

    Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolizat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1696-2012·2012-10-03

    Abbott Recalls Synthroid Tablets Due to Defective Bottle Bottoms

    Abbott Laboratories is recalling 40,464 bottles of Synthroid (levothyroxine sodium) 112 mcg tablets nationwide. The recall addresses a localized thin wall defect on the bottom of some bottles that may impact tablet stability.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2012·2012-10-03

    Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues

    Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.

    Product
    Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.

    Product
    Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 500
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2472-2012·2012-10-03

    Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters

    Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.

    Product
    Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization mate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2442-2012·2012-10-03

    Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling

    Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.

    Product
    Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization: ETO***ClearStream***
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2436-2012·2012-10-03

    Pulmuone Wildwood Organic Medium Salsa Recalled for Premature Spoilage

    Pulmuone Wildwood Inc. is recalling 575 units of Wildwood Emerald Valley Kitchen Organic Medium Salsa due to a potential non-safety quality concern causing premature spoilage.

    Product
    Wildwood Emerald Valley Kitchen Organic Medium Salsa - Canada (containing French in labeling), 397 mL. Pack size 6/14 oz per case. Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIU
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2443-2012·2012-10-03

    Terumo Advanced Perfusion System 1 Flow Pod Recall for False Alarms

    Terumo is recalling 150 Advanced Perfusion System 1 Flow Pods due to a circuit board defect that causes false back flow alarms when tubing is absent.

    Product
    Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualifie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2458-2012·2012-10-03

    Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error

    Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.

    Product
    The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1685-2012·2012-10-03

    Hospira Recalls Propofol Injectable Emulsion Due to Particulate Matter

    Hospira Inc. is recalling 148,630 vials of Propofol Injectable Emulsion because a single visible particulate was found in sample bottles during inspection.

    Product
    PROPOFOL — PROPOFOL (PROPOFOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2454-2012·2012-10-03

    Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date

    Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.

    Product
    Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2445-2012·2012-10-03

    Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues

    Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.

    Product
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1692-2012·2012-10-03

    Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch

    Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.

    Product
    Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration
    Category
    Drug
    Distribution
    11 states
  • SevereNHTSA·12V479000·2012-10-02

    Navistar Recalls 2007-2010 IC 3200IM Buses for Parking Brake Fire Risk

    Navistar is recalling 2007-2010 IC 3200IM commercial buses because a loss of air pressure may cause the parking brake to apply unexpectedly, potentially leading to a driveline fire.

    Product
    IC — IC 3200IM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12E036000·2012-10-02

    Federal-Mogul Recalls Aftermarket Fuel Pumps for Ford Vehicles

    Federal-Mogul is recalling specific aftermarket fuel pumps for 1989-1997 Ford vehicles because a seal failure can cause a fuel leak, posing a fire risk.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V480000·2012-10-02

    Aston Martin Recalls V12 Vantage Coupes for Tire Pressure Warning Defect

    Aston Martin is recalling 2010-2012 V12 Vantage Coupes because the tire pressure warning light may not illuminate until pressure is significantly low.

    Product
    ASTON MARTIN — ASTON MARTIN V12 VANTAGE COUPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13002·2012-10-02

    Haier Recalls 42-inch LED TVs Due to Stand Neck Breakage Risk

    Haier America is recalling 42-inch LED TVs because the stand's neck support can break, causing the TV to tip over. No injuries have been reported.

    Product
    Haier America Trading 42-inch LED Televisions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12E035000·2012-10-02

    Yakima Rooftop Rack Recall for 2012-2013 Ford Focus Vehicles

    Yakima is recalling specific rooftop rack systems for 2012-2013 Ford Focus vehicles because they may slide off when loaded, posing a hazard to others.

    Product
    FORD — FORD FOCUS
    Category
    Consumer Product
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2012.