The Recall Desk

Archive

September 2014 recalls

675 recalls were announced in September 2014.

What the numbers show

Critical
61
Severe
148
High
363
Moderate
91
Low
12

Of the 675 recalls this month scored against our rubric, 9% are Critical, 22% are Severe.

Which agencies issued them

101–200 of 675

  • ModerateFDA (Devices)·Z-2668-2014·2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2471-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Belgian Milk Chocolate Frozen Desserts

    Jenis Splendid Ice Creams LLC is recalling Belgian Milk Chocolate frozen desserts because the labels do not list ingredients.

    Product
    Belgian Milk Chocolate- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2473-2014·2014-09-24

    Jenis Savannah Buttermint Frozen Dessert Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Savannah Buttermint frozen dessert because the packaging does not list ingredients.

    Product
    Savannah Buttermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2464-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Goat Cheese Fig Cognac Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling goat cheese with Fig Cognac frozen dessert because the product labeling does not list ingredients.

    Product
    Goat cheese with Fig Cognac- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2452-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Backyard Mint Straciatella Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Backyard Mint Straciatella frozen dessert because the product labeling does not include ingredients.

    Product
    Backyard Mint Straciatella- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2472-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Saigon Cinnamon Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Saigon Cinnamon frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Saigon Cinnamon- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2640-2014·2014-09-24

    Amerx Recalls Amerigel Post-Op Surgical Kits for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amerigel Post-Op Surgical Kits because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2476-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Strawberry Rose Petal Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Strawberry Rose Petal frozen dessert because the product labeling does not include ingredients.

    Product
    Strawberry Rose Petal- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2638-2014·2014-09-24

    Amerx Recalls Amergel Wound Dressing Due to Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amergel Wound Dressing Maximum Strength because the product labeling contains unapproved claims regarding antimicrobial and autolytic debridement properties.

    Product
    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2481-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Winter Squash Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Winter Squash frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Winter Squash- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2634-2014·2014-09-24

    Fresenius Recalls BD Vacutainer PST Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling BD Vacutainer PST Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to be
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2655-2014·2014-09-24

    B. Braun AccuFlo Elastomeric Infusion Device Labeling Recall

    B. Braun Medical is recalling AccuFlo infusion devices in Missouri due to a mismatch between inner and outer packaging labels.

    Product
    B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device. AccuFlo devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2467-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Lime Cardamom Frozen Dessert for Labeling Defect

    Jenis Splendid Ice Creams LLC is recalling Lime Cardamom with Lingonberries frozen dessert because the product labeling does not include ingredients.

    Product
    Lime Cardamom with Lingonberries- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2462-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Dark Cocoa Smoked Almond frozen desserts because the packaging does not list ingredients.

    Product
    Dark Cocoa Smoked Almond- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2648-2014·2014-09-24

    Bard DuaLok Breast Lesion Localization Wire Recalled for Sterile Barrier Breach

    Bard Peripheral Vascular Inc is recalling Bard DuaLok Breast Lesion Localization Wires because portions of the wire may protrude from the packaging, breaching the sterile barrier.

    Product
    Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm); LW0057 (20gx57mm), LW0077(20gx77mm), LW0107(20gx107mm), LW0137(20gx137mm). The Bard DuaLok Breast Lesion Localization Wire is intended for use as a guide for directing surgical biop
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2661-2014·2014-09-24

    Teleflex Recalls Soft Rubber Bladder Catheters Due to Missing Latex Warning

    Teleflex Medical is recalling sterile soft rubber bladder catheters because the product labels failed to include a Natural Rubber Latex caution statement.

    Product
    Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2651-2014·2014-09-24

    Beckman Coulter Recalls Coulter DxH Diluent Due to Elevated Platelet Background Counts

    Beckman Coulter is recalling Coulter DxH Diluent because it may cause elevated platelet background counts, resulting in failed Daily Checks on specific Coulter Cellular Analysis Systems.

    Product
    Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2646-2014·2014-09-24

    Advanced Photonic Systems Recalls Luxurian Devices for Marketing Violations

    Advanced Photonic Systems is recalling 235 Luxurian devices because they were marketed without FDA clearance or approval.

    Product
    Luxurian. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. Company claims tha
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2631-2014·2014-09-24

    Fresenius Recalls BD Vacutainer SST Tubes for Improper Storage Temperature

    Fresenius Medical Care is recalling 9 boxes of BD Vacutainer SST Tubes held at improper storage temperatures. The tubes were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in chemistry.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2632-2014·2014-09-24

    Fresenius Recalls BD Vacutainer Trace Element Tubes Due to Storage Issues

    Fresenius Medical Care is recalling specific BD Vacutainer Trace Element Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements, aluminum
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2664-2014·2014-09-24

    Philips CT Systems Recalled for Software Image Overlap Defect

    Philips is recalling Brilliance 64 and Ingenuity CT systems because CIRS 4.0 Beta 2 software may cause images to overlap during reconstruction.

    Product
    The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equip
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2469-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Pumpkin 5 Spice Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Pumpkin 5 Spice frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Pumpkin 5 spice- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2453-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Berries and Burgundy frozen desserts because the packaging does not list ingredients.

    Product
    Berries and Burgundy- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2466-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Lapsang Souchong with Armagnac Prumes frozen desserts because the packaging does not list ingredients.

    Product
    Lapsang Souchong with Armagnac Prumes- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2641-2014·2014-09-24

    Amerx Recalls Amerigel Daily Dressing for Unapproved Labeling Claims

    Amerx Health Care Corp. is recalling Amerigel Daily Dressing Advanced 3-in-1 Hydrogel because the product labeling includes unapproved claims for antimicrobial and autolytic debridement.

    Product
    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1584-2014·2014-09-24

    Taro Recalls Warfarin Sodium Tablets Due to Content Uniformity Failures

    Taro Pharmaceuticals is recalling specific lots of Warfarin Sodium tablets because they failed content uniformity specifications. The affected products were distributed in seven US states.

    Product
    WARFARIN SODIUM — WARFARIN SODIUM (WARFARIN SODIUM)
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1586-2014·2014-09-24

    Solace International Recalls Dermatend Ultra for Unapproved Labeling Claims

    Solace International Inc. is recalling Dermatend Ultra skin tag remover because the product labeling contains unapproved claims and the product is not FDA approved.

    Product
    Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2647-2014·2014-09-24

    FDA Recalls Photonica Light Modulator for Marketing Without Clearance

    Advanced Photonic Systems is recalling 235 Photonica Light Modulator units because they were marketed without FDA clearance or approval.

    Product
    Photonica Light Modulator. These include all products labeled as UltraSlim, Luxurian, BioSlim Lipo, Cellulize, Slim 'n Trim, UltraRed, UltraBlue, Slim-PRO, Dazzle Light, UltraSlim Cold Light, SlenderRay, and U-Slim It, as well as those products with private labelling branding. C
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Food)·F-2482-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Winter Squash Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Winter Squash with Pecan Pralines frozen dessert because the packaging does not list ingredients.

    Product
    Winter Squash with Pecan Pralines- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2454-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Bourbon Egg Nog Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Bourbon Egg Nog frozen dessert because the product labeling does not include ingredients.

    Product
    Bourbon Egg Nog- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2458-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Frozen Desserts for Missing Ingredient Labels

    Jenis Splendid Ice Creams LLC is recalling Violet frozen desserts because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Violet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2455-2014·2014-09-24

    Jenis Cassis Sorbet Recalled for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Cassis Sorbet because the frozen dessert labels do not list ingredients. The product was distributed to all 50 states.

    Product
    Cassis Sorbet- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2475-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Star Anise Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Star Anise with Candied Fennel frozen dessert because the packaging does not list ingredients.

    Product
    Star Anise with Candied Fennel- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2470-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Root Beer Frozen Dessert for Missing Ingredients

    Jenis Splendid Ice Creams LLC is recalling Root Beer frozen dessert because the packaging does not list ingredients. The product was distributed to all 50 states.

    Product
    Root Beer- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2667-2014·2014-09-24

    Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes

    Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.

    Product
    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2479-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Torrone Frozen Dessert for Missing Ingredient Labeling

    Jenis Splendid Ice Creams LLC is recalling Torrone frozen dessert because the packaging does not list ingredients, posing a risk to consumers with allergies.

    Product
    Torrone- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2630-2014·2014-09-24

    Fresenius Recalls BD Vacutainer EDTA Tubes Due to Improper Storage

    Fresenius Medical Care is recalling 26 boxes of BD Vacutainer EDTA tubes held at improper storage temperatures. The affected lots were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2665-2014·2014-09-24

    Siemens CentraLink Data Management System Software Recall for Timer Overflow

    Siemens is recalling CentraLink Data Management System software version 14 due to a task scheduler issue that may stop command execution and result uploads.

    Product
    Siemens CentraLink Data Management System, software version 14. The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2461-2014·2014-09-24

    Jenis Splendid Ice Creams Recalls Dark Cocoa Peppermint Frozen Dessert

    Jenis Splendid Ice Creams LLC is recalling Dark Cocoa Peppermint frozen dessert because the product labeling does not include ingredients.

    Product
    Dark Cocoa Peppermint- possible pints/possible half gallon. Flavor of frozen dessert on the immediate package. No ingredients listed.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2649-2014·2014-09-24

    Siemens Axiom Luminos dRF Recalled for Fluid Infiltration Malfunction Risk

    Siemens is recalling 33 Axiom Luminos dRF systems because fluid exposure to the tableside control panel may cause a malfunction and automatic shutdown.

    Product
    AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2629-2014·2014-09-24

    Fresenius Recalls BD Vacutainer Serum Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling 3 boxes of BD Vacutainer Serum Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2666-2014·2014-09-24

    Philips Brilliance CT Big Bore Recalled for Emergency Stop Defect

    Philips Medical Systems is recalling 257 Brilliance CT Big Bore systems because the emergency stop function may activate while the system is idle, halting all movements and scans.

    Product
    The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data from the same axial plane taken at different angles. Model Numbers 728244 and 728243.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2449-2014·2014-09-24

    Dannon Activia Yogurt Recalled for Potential Antibiotic Contamination

    Dannon is recalling Activia Lowfat Blueberry Yogurt because it may contain condensed skim milk produced from raw milk testing positive for sulfamethazine.

    Product
    Activia Lowfat Yogurt Blueberry 4 x 4oz, Form Fill Seal plastic cups.
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2662-2014·2014-09-24

    Siemens ADVIA Centaur Immunoassay System Field Correction for Sample Rack Loading

    Siemens is correcting ADVIA Centaur systems where improperly loaded sample racks may cause sample ID misreads.

    Product
    ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 10313282, 10314322, 10316248, 10316372, 10316968, 10317060, 10317403, 10319111, 10319433, 10320929, 10321568, 10322149, 10322731, 10323204, 10325015,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1570-2014·2014-09-24

    Apotex Recalls Candesartan Cilexetil and Hydrochlorothiazide Tablets Due to Impurity

    Apotex Corp. is recalling Candesartan Cilexetil and Hydrochlorothiazide Tablets because a specific degradant exceeded safety specifications.

    Product
    Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2650-2014·2014-09-24

    Stago IVD Liquid Anti-Xa Recalled for Barcode Misreading

    Diagnostica Stago is recalling 514 Liquid Anti-Xa kits due to customer complaints about barcode misreading on analyzers.

    Product
    Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2644-2014·2014-09-24

    BioFire Defense Recalls JBAIDS Instrument System Software Version 3.5.0.72

    BioFire Defense is recalling JBAIDS Instrument System Software version 3.5.0.72 because the wrong version may have been installed on the devices.

    Product
    JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is a portable thermocycler and real-time fluorimeter capable of simultaneous and rapid identification of multiple biological warfare and clinical pathogens from a variety of biological specimens. The sof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V588000·2014-09-23

    Freightliner Recalls 2014-2015 Cascadia Trucks Due to Inverter Fire Risk

    Daimler Trucks is recalling 2014-2015 Freightliner Cascadia trucks because certain auxiliary power unit inverters may spark or overheat, posing a fire hazard.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V589000·2014-09-23

    Freightliner M2 Recalled for CNG Fuel Valve Defect

    Daimler Trucks is recalling 2013 Freightliner M2 vehicles with specific CNG fuel systems because a stuck valve poses injury and fire risks.

    Product
    FREIGHTLINER — FREIGHTLINER M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·059-2014·2014-09-23

    Monogram Recalls Uncured Beef Corn Dogs Due To Temperature Abuse

    Monogram Frozen Foods is recalling 607 pounds of Applegate Naturals Uncured Beef Corn Dogs because they may have been stored at unsafe temperatures.

    Product
    Monogram Frozen Foods — Indiana Firm Recalls Uncured Beef Corn Dogs Due To Possible Temperature Abuse
    Category
    Food
    Distribution
    6 states
  • HighCPSC·14279·2014-09-23

    Hearth & Home Technologies Recalls Gas Fireplaces Due to Gas Leak Risk

    Hearth & Home Technologies is recalling about 20,000 gas fireplaces, stoves, inserts, and log sets because the gas valve can leak, posing a fire hazard.

    Product
    Gas fireplaces, gas stoves, gas inserts and log sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V587000·2014-09-23

    NABI Transit Buses Recalled for Missing Wheelchair Lift Interlock

    NABI is recalling 2012 31LFW and 2008-2013 416 transit buses because they may lack a transmission interlock for wheelchair lifts, posing an injury risk.

    Product
    NABI — NABI 31LFW, 416
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V590000·2014-09-23

    Daimler Recalls 2015 Minotour School Buses for Electrical Fuse Defect

    Daimler Trucks North America is recalling 2015 Minotour school buses because using hazard and brake lights simultaneously may blow a fuse, disabling both systems and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V585000·2014-09-23

    Jayco Recalls 2015 Jay Flight Travel Trailers Due to Fire Risk

    Jayco is recalling 114 model year 2015 Jay Flight travel trailers because inadequate venting from the range could allow propane gas to accumulate and ignite, causing a fire.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V584000·2014-09-23

    National Van Recalls Ford E-Series Vans with Cracking Wheelchair Lifts

    National Van is recalling 2007-2014 Ford E-150 and E-250 vans equipped with specific Ricon wheelchair lifts. The platform side plates may crack, causing the lift to fall and injure the operator.

    Product
    FORD — FORD E-250, E-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V582000·2014-09-22

    Nissan Recalls 2014 Infiniti Hybrid Vehicles for Transmission Housing Defect

    Nissan is recalling 817 model year 2014 Infiniti Q50 and Q70 hybrid vehicles because damaged transmission housings could crack, creating road debris and disabling the vehicle.

    Product
    INFINITI — INFINITI Q50 HYBRID, Q70 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V579000·2014-09-22

    Kalmar Recalls 2014 Ottawa T2 Tractors Due to Fuel Filter Defect

    Kalmar is recalling 276 model year 2014 Ottawa T2 terminal tractors because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V583000·2014-09-22

    Nissan Recalls Infiniti Hybrid Vehicles for Throttle Control Software Error

    Nissan is recalling specific Infiniti hybrid models because a software error may cause the vehicle to accelerate unexpectedly if a sensor signal is lost and restored.

    Product
    INFINITI — INFINITI Q50 HYBRID, M35 HYBRID, Q70 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V578000·2014-09-22

    Starcraft RV Recalls 2015 AR-One Travel Trailers for Fire Risk

    Starcraft RV is recalling 72 model year 2015 AR-One travel trailers because inadequate kitchen venting could allow propane gas to ignite, causing a fire.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AR-ONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E064000·2014-09-22

    Auto Pro Recalls Steering Hub Adapters for 1967-1968 Camaros

    Auto Pro USA is recalling steering hub adapters for 1967 and 1968 Camaros because they may cause the steering wheel to misalign, increasing crash risk.

    Product
    STEERING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E063000·2014-09-22

    Auto Pro Recalls Steering Hub Adapters for 1969-1970 Camaros

    Auto Pro USA is recalling aftermarket steering hub adapters for 1969 and 1970 Camaros because they may cause the steering wheel to become misaligned, increasing the risk of a crash.

    Product
    STEERING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V581000·2014-09-22

    Nissan Recalls 2014 Infiniti Hybrid Vehicles Due to Software Error

    Nissan is recalling 2014 Infiniti Q50 and Q70 hybrid vehicles because a software error may cause the electric motor to stop working, increasing crash risk.

    Product
    INFINITI — INFINITI Q70 HYBRID, Q50 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V571000·2014-09-19

    GM Recalls Cadillac SRX and Saab 9-4X for Rear Suspension Defect

    General Motors is recalling 2010-2015 Cadillac SRX and 2011-2012 Saab 9-4X vehicles because a loose rear suspension part may cause loss of vehicle control.

    Product
    CADILLAC — CADILLAC, SAAB SRX, 9-4X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V576000·2014-09-19

    Toyota Recalls 2014-2015 Models for Fuel Delivery Pipe Leak Risk

    Toyota is recalling 2014 Avalon, Camry, Sienna, Highlander, and 2015 Lexus RX350 vehicles because fuel may leak from a delivery pipe, increasing fire risk.

    Product
    TOYOTA — TOYOTA, LEXUS SIENNA, RX350, CAMRY, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V570000·2014-09-19

    GM Recalls 2015 Chevrolet Corvette for Driver Air Bag Defect

    General Motors is recalling 2015 Chevrolet Corvette vehicles because the driver air bag module back plate may fracture, allowing the air bag to separate from the steering wheel.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V577000·2014-09-19

    Subaru Recalls 2015 Outbacks Due to Trailer Hitch Mounting Nut Defect

    Subaru is recalling 2015 Outbacks with accessory trailer hitches because overtightened mounting nuts may cause hitch failure. Owners should contact dealers to replace nuts and inspect studs.

    Product
    SUBARU — SUBARU OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V574000·2014-09-19

    Navistar Recalls 2011-2012 Workhorse W62 Chassis for Exhaust Weld Defect

    Navistar is recalling 2011-2012 Workhorse W62 commercial chassis because a weld on the exhaust system may fatigue, allowing hot gases to enter the engine compartment and increasing fire risk.

    Product
    WORKHORSE — WORKHORSE W62
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V573000·2014-09-19

    Navistar Recalls 2015 IC Bus CE School Buses for Fuel Filter Defect

    Navistar is recalling 782 model year 2015 IC Bus CE school buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    IC BUS — IC BUS CASB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V572000·2014-09-19

    Navistar Recalls 2015 International Durastar and IC Bus CE Vehicles

    Navistar is recalling 2015 International Durastar and IC Bus CE vehicles because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    IC BUS — IC BUS, INTERNATIONAL CE, DURASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14278·2014-09-18

    Siemens Recalls SBGA-34 Audible Fire Alarm Bases Due to Injury Risk

    Siemens is recalling about 9,000 SBGA-34 audible fire alarm bases because they may fail to sound an alarm, posing a risk of personal injury and property damage.

    Product
    SBGA-34 Audible Fire Alarm Base
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2422-2014·2014-09-17

    YF Brand Sesame Cracker Recalled for Undeclared Peanuts

    Domega NY International Co Ltd is recalling YF brand Sesame Crackers because they contain undeclared peanuts. The product was sold in the New York City area.

    Product
    YF brand CRACKER (SESAME), Net Wt. 14 oz. (400g), UPC 6 920580 733416 --- The product is packed in a plastic package.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V567000·2014-09-17

    Chrysler Recalls 2008 Vehicles for Ignition Switch Sticking Defect

    Chrysler is recalling 2008 Chrysler 300, Dodge Charger, Dodge Magnum, Jeep Commander, and Jeep Grand Cherokee vehicles because the ignition key may stick, potentially causing the engine to turn off while driving.

    Product
    DODGE — DODGE, JEEP, CHRYSLER CHARGER, MAGNUM, COMMANDER, 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V569000·2014-09-17

    Van Hool Recalls TD925 Buses Due to Steering Knuckle Cracking Risk

    Van Hool is recalling 2011-2013 TD925 buses because the front steering knuckle carrier may crack, potentially causing a wheel to separate and increasing crash risk.

    Product
    VAN HOOL — VAN HOOL TD925
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2418-2014·2014-09-17

    Whole Foods Chocolate Chewies Cookies Recalled for Undeclared Walnuts

    Whole Foods Market is recalling Chocolate Chewies Cookies sold in Massachusetts due to undeclared walnuts.

    Product
    Whole Foods Market Chocolate Chewies Cookies in clamshell packaging, sold by the lb. Item # 6126
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V568000·2014-09-17

    GM Recalls 2015 Chevrolet Corvette for Parking Brake Cable Defect

    General Motors is recalling 2015 Chevrolet Corvettes because a parking brake cable may not be fully seated, causing the vehicle to roll away on steep gradients.

    Product
    CHEVROLET — CHEVROLET CORVETTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2627-2014·2014-09-17

    Stryker Recalls Aria Inserter Devices Due to Product Fracturing

    Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

    Product
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in
    Category
    Medical Device
    Distribution
    24 states
  • SevereNHTSA·14V566000·2014-09-17

    Daimler Trucks Recalls 2015 Freightliner and FCCC Vehicles for Fuel Filter Defect

    Daimler Trucks is recalling 6,759 model year 2015 Freightliner, FCCC, Thomas Built Buses, and Western Star vehicles because a fuel filter component may separate, causing the engine to stall without warning.

    Product
    FCCC — FCCC, FREIGHTLINER, THOMAS BUILT BUSES MT45, XCS, XCM, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2424-2014·2014-09-17

    Hong Lee Trading Recalls Young Coconut Candy for Undeclared Sulfites and Colors

    Hong Lee Trading Inc. is recalling Young Coconut Candy sold in New York State due to undeclared sulfites and food dyes.

    Product
    Mut Dua Non YOUNG COCONUT CANDY, Net Weight: 10.6oz (300g), UPC 8 935054 702377 -- Product of Vietnam -- Packed for: HONG LEE TRADING INC. 225 JOHNSON AVE BROOKLYN, NEW YORK 11206 (718) 386-2100 --- NUTRITION FACTS: Serving Size 30oz. (85g), Servings per container 6
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2626-2014·2014-09-17

    Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

    Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

    Product
    Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal f
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Food)·F-2417-2014·2014-09-17

    El Tampiqueno Queso Fresco Recalled for Potential Salmonella Contamination

    El Tampiqueno Food Products is recalling specific lots of Original Queso Fresco White Soft Cheese due to potential Salmonella contamination. The product was distributed in Texas.

    Product
    El Tampiqueno Original Queso Fresco White Soft Cheese, Manufactured and distributed by El Tampiqueno Cheese Products, 1210 Summit St. Schulenberg, Texas 78956
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2608-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 50 units of CLAW II Straight Plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1583-2014·2014-09-17

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 157,080 containers of 0.9% Sodium Chloride Injection due to complaints of mold in the overpouch, raising concerns about sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2420-2014·2014-09-17

    CT Concerns Recalls Fresh Wild Tuna and Salmon for Listeria Risk

    CT Concerns, Inc. is voluntarily recalling fresh wild tuna and farmed Atlantic salmon due to potential Listeria monocytogenes contamination found in environmental swabs.

    Product
    Fresh Wild Tuna. No finished packaging. Fresh Tuna is placed in white styrofoam box and delivered to area restaurants.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2425-2014·2014-09-17

    Marjon Alfalfa Sprouts Recalled Due to Listeria Contamination Risk

    Marjon Specialty Foods is recalling Marjon Alfalfa Sprouts because environmental samples in the production area tested positive for Listeria.

    Product
    Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2423-2014·2014-09-17

    GONG XIFACAI gift chocolates recalled for undeclared peanuts and milk

    The FDA is recalling GONG XIFACAI gift chocolates because testing revealed undeclared peanuts and milk in the product.

    Product
    GONG XIFACAI GIFT CHOCOLATES, 238 grams, UPC 6 934169 900335 --- MANUFACTURER: JIANGXI GOLDEN EAGLE FOOD CO. LTD, ADD: NO. 188, YONGQIANG ROAD (NORTH), WANGCHENG TOWN, XINJIAN COUNTY, JIANGXI, CHINA 330100 --- The product is packed in a plastic tray with a plastic overwrap packag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2429-2014·2014-09-17

    H-E-B Chipotle Con Queso Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling H-E-B Chipotle Con Queso because a supplier used wheat instead of whey in the cheese premix, creating an undeclared wheat allergen.

    Product
    H-E-B Chipotle Con Queso; HOT; with Real Chipotle Peppers; NET WT; 16 OZ (1 LB) 454g; Made with Pride and Care for H-E-B, SAN ANTONIO, TEXAS 78204. Distributed in cases of 12/16 oz. jars.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2432-2014·2014-09-17

    Hy-Top French Onion Dip Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Hy-Top French Onion Dip because a supplier used wheat instead of whey in the cheese premix.

    Product
    HY-TOP FRENCH ONION DIP; NET WT 9 OZ. (255g); DISTRIBUTED BY FEDERATED GROUP, INC.; ARLINGTON HEIGHTS IL. 60005-1096. Shipped in cases of 12/9 oz containers.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2431-2014·2014-09-17

    Roundy's Salsa Con Queso Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Roundy's Salsa Con Queso because a supplier used wheat instead of whey in the cheese premix, creating an undeclared wheat allergen.

    Product
    Roundy's Salsa Con Queso; NET WT; 16 OZ (1 LB) 454g; DISTRIBUTED BY Roundy's Milwakee, WI 53202. Distributed in cases of 12/16 W jars.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2607-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2428-2014·2014-09-17

    Marjon Spicy Sprouts Recalled Due to Listeria Contamination

    Marjon Specialty Foods is recalling Marjon Spicy Sprouts because environmental samples found Listeria in the production area.

    Product
    Marjon Spicy Sprouts, NET WT. 6/6 oz. packaged in bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 010077554000197. Used by 7/06/14.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2611-2014·2014-09-17

    Illumina Worklist Manager Software Recalled for Performance Failure

    Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.

    Product
    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2014·2014-09-17

    GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure

    GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.

    Product
    CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with CARESCA
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2014·2014-09-17

    Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure

    Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.

    Product
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2014·2014-09-17

    Pioneer Surgical Technology Recalls Streamline MIS Spinal Fixation System Fixed Rod Holders

    Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.

    Product
    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2430-2014·2014-09-17

    Hill Country Fare Salsa Con Queso Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Hill Country Fare Salsa Con Queso Sauce due to undeclared wheat, a common allergen.

    Product
    HILL COUNTRY FARE; Salsa Con QUESO Sauce; Medium - PICANTE; NET WT 16 OZ (1LB) CONT. NET. 454g; DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78294. distributed in cases of 12/16 oz. jars
    Category
    Food
    Distribution
    3 states

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