The Recall Desk

Archive

October 2013 recalls

353 recalls were announced in October 2013.

What the numbers show

Critical
3
Severe
124
High
116
Moderate
95
Low
15

Of the 353 recalls this month scored against our rubric, 1% are Critical, 35% are Severe.

201–300 of 353

  • HighNHTSA·13V496000·2013-10-17

    Freightliner M2 Emergency Vehicle Recall for Engine Shutdown Software Issue

    Daimler Trucks North America is recalling 2014 Freightliner Business Class M2 emergency vehicles because engine shutdown software may not be disabled, potentially hampering rescue operations.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V504000·2013-10-17

    Blue Bird School Bus Recall for Flip Seat Pinch Hazard

    A-Z Bus Sales is recalling 2005-2013 Blue Bird A3RE and D3RE school buses to fix a pinch point hazard in C.E. White flip seats.

    Product
    BLUE BIRD — BLUE BIRD A3RE, D3RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V511000·2013-10-17

    Gulf Stream Travel Trailer Door Lock Recall for Jamming Hazard

    Gulf Stream is recalling 2007-2013 travel trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside the vehicle.

    Product
    GULF STREAM — GULF STREAM PRAIRIE SCHOONER, NORTHERN EXPRESS, G FORCE, GULF BREEZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V488000·2013-10-17

    GM Recalls 2014 Silverado and Sierra for Head Restraint Defect

    General Motors is recalling 2014 Chevrolet Silverado and GMC Sierra 1500 trucks because front seatbacks may have play, failing federal head restraint safety standards.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E057000·2013-10-17

    Keyline Sales Recalls Exterior Doors for Potential Lock Jamming Hazard

    Keyline Sales is recalling exterior doors for cargo and specialty trailers built with Fastec-brand locks. The defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V508000·2013-10-17

    Big Tex Recalls Utility Trailers Due to Ramp Gate Latch Failure

    Big Tex is recalling 2013-2014 utility trailers because vibrations may cause ramp gate latches to fail, increasing crash risk.

    Product
    BIG TEX — BIG TEX 29SA, 70TV, 70SP, 70LR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V506000·2013-10-17

    Porsche Recalls 2013-2014 Cayenne Models for Fuel Gauge Inaccuracy

    Porsche is recalling specific 2013-2014 Cayenne vehicles because the fuel gauge may display higher levels than actual, increasing the risk of stalling and crashes.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V491000·2013-10-17

    Harley-Davidson Recalls 2014 Trikes for Brake Fluid Leak Risk

    Harley-Davidson is recalling 2014 Trikes because a machined part may cause brake fluid loss or steering damage, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON TRIKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V509000·2013-10-17

    Outdoors RV Recalls Travel Trailers Due to Door Lock Jamming Risk

    Outdoors RV is recalling specific travel trailers because a defect in the door lock may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    WIND RIVER — WIND RIVER, TIMBER RIDGE, TAMARACK TRAILS TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V482000·2013-10-17

    Vintage Trailers Recall 2007-2013 Models Due to Door Lock Jamming Risk

    Vintage Trailers is recalling 4,212 travel trailers from 2007-2013 because a door lock defect could jam the deadbolt, trapping occupants inside the vehicle.

    Product
    VINTAGE — VINTAGE CARGO, OUTLAW, CRYSTAL, BANDIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V521000·2013-10-17

    Nissan Recalls 2013 NV200 Vehicles for Wiring Harness Defect

    Nissan is recalling 2,529 model year 2013 NV200 vehicles because a wiring harness may wear through its covering, potentially causing a short circuit that stops the engine while driving.

    Product
    NISSAN — NISSAN redundant NV200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V479000·2013-10-17

    Shadow Trailers Recalls Horse Trailers Due to Door Lock Jamming Risk

    Shadow Trailers is recalling 2006-2012 gooseneck and bumperpull horse trailers because a defect in certain door locks may jam the deadbolt, potentially trapping occupants inside.

    Product
    SHADOW — SHADOW BUMPERPULL, GOOSENECK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V505000·2013-10-17

    Toyota Recalls 2013-2014 Models for Windshield Wiper Switch Defect

    Toyota is recalling specific 2013-2014 Corolla, Camry, and Avalon vehicles because a short circuit in the wiper switch may cause the wipers to stop working, reducing visibility.

    Product
    TOYOTA — TOYOTA COROLLA, CAMRY, CAMRY HYBRID, AVALON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·13V475000·2013-10-17

    Ford Recalls 2012-2013 C-Max and Focus Electric for Missing Door Chime

    Ford is recalling 23,000 vehicles because the door chime does not sound when the driver's door is opened while the vehicle is on, increasing theft risk.

    Product
    FORD — FORD C-MAX, FOCUS ELECTRIC, C-MAX ENERGI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0007-2014·2013-10-16

    Bard Recalls LifeStent Solo Vascular Stents Due to Deployment Issues

    Bard Peripheral Vascular is recalling specific lots of LifeStent Solo Vascular Stents due to a higher incidence of partial stent deployment.

    Product
    Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66295-001·2013-10-16

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns

    Hospira is recalling 187,150 vials of Bupivacaine Hydrochloride with Epinephrine due to a lack of assurance of sterility and potential vial breakage.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2014·2013-10-16

    Draeger Fabius Anesthesia Machines Recalled for Electrical Clearance Defects

    Draeger Medical is recalling 1,127 Fabius anesthesia machines worldwide because some units failed high-voltage tests and did not maintain minimum electrical clearance.

    Product
    Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66360-001·2013-10-16

    Watson Recalls Next Choice Emergency Contraceptive Tablets Due to Breakage

    Watson Laboratories is recalling Next Choice emergency contraceptive tablets because they may break when pushed through the packaging.

    Product
    Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-66373-001·2013-10-16

    Sandoz Recalls Hydroxychloroquine Tablets Due to Illegible Logo

    Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets because the logo on some tablets is illegible.

    Product
    Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2295-2013·2013-10-09

    MedStream Refill Kit Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the fillin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2298-2013·2013-10-09

    MedStream Refill Kit Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff, Inc. is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2297-2013·2013-10-09

    MedStream Refill Kit Recall for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2293-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling two MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2296-2013·2013-10-09

    MedStream Refill Kit Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.

    Product
    MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2300-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1066-2013·2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling specific lots of Ifosfamide Injection because they were not refrigerated at certain distribution centers.

    Product
    Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66241-001·2013-10-09

    Apothecary Shoppe Recalls Estradiol and Progesterone Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling Estradiol and Progesterone injectable vials due to concerns about sterility assurance with its testing laboratory.

    Product
    Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1068-2013·2013-10-09

    Triangle Compounding Recalls Sodium Phosphate Injectable Due to Sterility Concerns

    Triangle Compounding is recalling 54 vials of Sodium Phosphate Injectable because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-66251-001·2013-10-09

    Watson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination

    Watson Laboratories is recalling Oxycodone and Acetaminophen Tablets because foreign tablets were found in a sealed bottle.

    Product
    Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1065-2013·2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL because they were not properly refrigerated at distribution centers.

    Product
    Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0006-2014·2013-10-09

    H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing

    H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.

    Product
    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2294-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the fil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66241-002·2013-10-09

    Apothecary Shoppe Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling 1,430 mL of Testosterone Cypionate 200 mg/mL Injectable in Oklahoma due to concerns about sterility assurance.

    Product
    SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1069-2013·2013-10-09

    Triangle Compounding Recalls Histamine Injectable Due to Sterility Concerns

    Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2299-2013·2013-10-09

    Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66201-001·2013-10-09

    Hospira Recalls Lidocaine Ampuls Due to Visible Particulate Matter

    Hospira is recalling 86,400 ampuls of 5% Lidocaine HCl and 7.5% Dextrose Injection due to reports of visible particulates in the glass ampules.

    Product
    5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2014·2013-10-09

    PhotoMedex Recalls SLT Fiber Delivery Systems Due to Sterility Concerns

    PhotoMedex is recalling 549 units of SLT Fiber Delivery Systems because some may not have been sealed appropriately, compromising the sterile barrier.

    Product
    The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product N
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0001-2014·2013-10-09

    Maquet Recalls Ultima OPCAB Systems Due to Incorrect Blade Labeling

    Maquet Cardiovascular is recalling specific lots of Ultima OPCAB Systems because standard and deep blades were incorrectly labeled, posing a risk during cardiac surgery.

    Product
    Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2013·2013-10-09

    Hologic Selenia Mammography System Software Recall for Image Deletion

    Hologic is recalling 62 Selenia Full Field Digital Mammography Systems because software versions 5.0.x and 5.1.x may delete recent images when the hard drive reaches a 4,000-image threshold.

    Product
    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2272-2013·2013-10-09

    King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling

    King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.

    Product
    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2013·2013-10-09

    McKesson Horizon Medical Imaging System Recalled for Potential Image Loss

    McKesson Information Solutions LLC is recalling Horizon Medical Imaging software versions 4.6.1 to 11.6. because a server configuration malfunction may cause the loss of digital medical images.

    Product
    McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medi
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2292-2013·2013-10-09

    Ebi Solitaire-35 Spinal Fusion Device Recalled for Screw Complaints

    Ebi, LLC is recalling 1,730 units of the Solitaire-35 PEAK Solitaire Anterior Spinal System due to complaints regarding one of the three screws driving through the cage.

    Product
    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2014·2013-10-09

    Cordis ADROIT 6F Guiding Catheter Recalled for Labeling Error

    Cordis Corporation is recalling 1,238 units of ADROIT 6F Guiding Catheters due to a labeling error regarding the conversion of the inner diameter from inches to millimeters.

    Product
    Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0002-2014·2013-10-09

    King Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error

    King Systems Corp. is voluntarily recalling one case of King LTS-D Oropharyngeal Airways because the package label incorrectly identified the size.

    Product
    King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspirati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2013·2013-10-09

    Atrium Flixene IFG Recall Due to Label Adhesion Issue

    Atrium Medical Corporation is recalling Flixene IFG with Assisted Delivery because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1963-2013·2013-10-09

    Novartis Recalls Benefiber Fiber Supplement Due to Consumer Complaints

    Novartis Consumer Health is recalling specific bottles of Benefiber Fiber Supplement Plus Calcium due to a high number of consumer complaints.

    Product
    Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2304-2013·2013-10-09

    Atrium Medical Recalls Advanta VXT Vascular Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta VXT Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Bifurcated Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SST Bifurcated Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2302-2013·2013-10-09

    Medtronic NC Sprinter Balloon Catheter Recalled for Incorrect Size Labeling

    Medtronic is recalling 122 units of NC Sprinter Balloon Dilatation Catheters because the compliance chart lists the size as 2.5mm instead of the correct 2.25mm.

    Product
    NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplas
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2319-2013·2013-10-09

    DeVilbiss Disposable Suction Container Filter Recall Due to Fluid Exposure

    DeVilbiss Healthcare LLC is recalling specific Disposable Suction Container/Filter units because fluid exposure can occlude the bacterial filter, rendering it unusable.

    Product
    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Contain
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2306-2013·2013-10-09

    Atrium Medical Recalls Advanta SuperSoft Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2013·2013-10-09

    Atrium Medical Recalls Advanta VS Grafts Due to Label Adhesion Issue

    Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making removal difficult.

    Product
    Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2303-2013·2013-10-09

    Radiometer Lactate Membrane Units Recalled for Enzyme Residue

    Radiometer America Inc. is recalling Lactate Membrane units for the E7077 Electrode due to potential enzyme residue that may cause inaccurate test results.

    Product
    Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2014·2013-10-09

    ASO Recalls SHOPKO Waterproof Adhesive Pads Labeled as Antibacterial

    ASO, LLC is recalling SHOPKO Waterproof Adhesive Pads because they were labeled as antibacterial but did not contain antibacterial ingredients.

    Product
    SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2314-2013·2013-10-09

    Atrium Flixene Grafts Recalled Due to Difficult Tray Removal

    Atrium Medical Corporation is recalling Flixene Trumpet Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making removal difficult.

    Product
    Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2013·2013-10-09

    Atrium Medical Recalls Advanta VS Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta VS Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1959-2013·2013-10-09

    Novartis Recalls Benefiber Fiber Supplement Due to Consumer Complaints

    Novartis Consumer Health is recalling specific bottles of Benefiber Fiber Supplement because of a high number of consumer complaints.

    Product
    Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Con
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2291-2013·2013-10-09

    GE Healthcare Recalls MR Scanners Due to Exposed Foam on End Bells

    GE Healthcare is recalling specific MRI scanners because yellow foam on the end bells may extend past the covers. The foam itself is not hazardous, but it may absorb fluids.

    Product
    GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa¿ MR 750 System is indicated for use as a diagnostic imaging device to produce axial,
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1064-2013·2013-10-09

    Marlex Acetaminophen Tablets Recalled for Manufacturing Practice Deviations

    Marlex Pharmaceuticals is recalling 28,387 bottles of Acetaminophen Tablets, 500 mg, because the lot was not manufactured under current good manufacturing practices.

    Product
    Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2310-2013·2013-10-09

    Atrium Flixene Grafts Recalled Due to Difficult-to-Remove Inner Tray Label

    Atrium Medical Corporation is recalling Flixene Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2013·2013-10-09

    Atrium Medical Recalls Advanta SuperSoft Grafts Due to Label Adhesion

    Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1966-2013·2013-10-09

    Green Mountain Coffee Recalls Tully's Decaf K-Cup Packs Due to Caffeine Contamination

    Green Mountain Coffee Roasters is recalling Tully's House Blend Decaffeinated K-Cup Packs because regular caffeinated packs were mistakenly included in decaffeinated retail boxes.

    Product
    Tully's House Blend Decaffeinated K-Cup¿ Packs (12-ct retail box) Product Code: 8803; UPC: 099555088038
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2313-2013·2013-10-09

    Atrium Medical Recalls Advanta VXT Grafts Due to Label Adhesion Issue

    Atrium Medical Corporation is recalling Advanta VXT Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2013·2013-10-09

    CareFusion Recalls AVEA Ventilators for Barometric Pressure Error

    CareFusion is voluntarily correcting AVEA ventilators to fix a barometric pressure compensation error identified during a proactive review.

    Product
    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1962-2013·2013-10-09

    Novartis Recalls Benefiber Fiber Drink Mix Due to Consumer Complaints

    Novartis Consumer Health is recalling Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, due to a high number of consumer complaints.

    Product
    Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1961-2013·2013-10-09

    Novartis Recalls Benefiber Fiber Drink Mix Due to Consumer Complaints

    Novartis Consumer Health is recalling Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, due to a high number of consumer complaints.

    Product
    Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1960-2013·2013-10-09

    Novartis Recalls Benefiber Plus Heart Health Powder Due to Consumer Complaints

    Novartis Consumer Health is recalling Benefiber Plus Heart Health Non-Thickening Powder due to a high number of consumer complaints. The product was distributed nationwide and to Panama and Belize.

    Product
    Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622. Made in France.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1964-2013·2013-10-09

    Novartis Recalls Benefiber Non-Thickening Powder Due to Consumer Complaints

    Novartis Consumer Health is recalling Benefiber Non-Thickening Powder, Sugar Free, due to a relatively high number of consumer complaints.

    Product
    Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations: (1) 2.8-oz. (20 servings) bottles, UPC 300670044206; (2) 4.6-oz. (32 servings) bottles, UPC 300670044329; (3) 5.4-oz. (38 servings) bottles, UPC 300670044381; (4) 8.6-oz. (62 ser
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1965-2013·2013-10-09

    Green Mountain Coffee Recalls Tully's House Blend K-Cup Packs

    Green Mountain Coffee Roasters is recalling Tully's House Blend K-Cup packs because regular caffeinated units were packaged in decaffeinated retail boxes.

    Product
    Tullys¿ House Blend Coffee 12-ct K-Cup¿ packs; Product Code: 8802 (Case of 6 - 12 count retail boxes) UPC: 10099555088028
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-2316-2013·2013-10-09

    Atrium Medical Recalls Advanta SST Grafts Due to Label Adhesion Issue

    Atrium Medical Corporation is recalling Advanta SST Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1067-2013·2013-10-09

    Osmotica Recalls Venlafaxine Extended Release Tablets for Dissolution Failure

    Osmotica Pharmaceutical Corp. is recalling specific lots of Venlafaxine extended release tablets because they failed to meet dissolution specifications at 18 months.

    Product
    Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2305-2013·2013-10-09

    Atrium Flixene IFG Vascular Grafts Recalled for Label Adhesion Issue

    Atrium Medical Corporation is recalling Flixene IFG Vascular Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.

    Product
    Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1910-2013·2013-10-02

    Bubbles Baking Blueberry Muffins Recalled for Undeclared Milk and Soy

    Bubbles Baking Co. is recalling First Street Blueberry Muffins Loaf because they may contain undeclared milk and soy allergens.

    Product
    First Street Blueberry Muffins Loaf (S 45383), 16 oz., 12 trays/case, UPC 0 41512 10854 9.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1063-2013·2013-10-02

    Walgreens Recalls Progesterone Injection Lot Due to Sterility Concerns

    Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate injection due to sterility assurance concerns with its testing laboratory.

    Product
    Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1957-2013·2013-10-02

    Blythedale Farm Camembert Recalled for Inadequate Pasteurization

    Blythedale Farm Inc. is recalling 9,078 units of Camembert Vermont due to inadequate pasteurization. The product was distributed across 10 states and DC.

    Product
    Blythedale Farm Camembert Vermont, 7 oz wrapped disc in plastic cup UPC Code: 762713669027
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1956-2013·2013-10-02

    Blythedale Farm Farmstead Brie Recalled for Inadequate Pasteurization

    Blythedale Farm Inc. is recalling 143 units of Farmstead Brie due to inadequate pasteurization. The product was distributed across ten states and Washington, D.C.

    Product
    Blythedale Farm Farmstead Brie, 1 lb white wrapped disc UPC Code:
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2270-2013·2013-10-02

    Invacare Power Wheelchair Recall for Unintended Slowing or Acceleration

    Invacare is recalling power wheelchairs with specific joysticks due to unintended slowing or acceleration. Users should stop using the device and contact Invacare.

    Product
    Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
    Category
    Medical Device
    Distribution
    53 states
  • SevereFDA (Food)·F-1949-2013·2013-10-02

    Mothers Milk Bank Recalls Pasteurized Human Breast Milk Due to Hepatitis B

    Mothers Milk Bank is recalling 70 bottles of pasteurized human breast milk because the donor tested reactive for Hepatitis B. The product was distributed to six hospitals in Honolulu and California.

    Product
    Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1923-2013·2013-10-02

    Healthmaxx Recalls MAX Brand Super Selenium 250 Tablets for Mislabeling

    Healthmaxx Global Inc. is voluntarily recalling MAX Brand Super Selenium 250 tablets because the product label does not match the actual contents.

    Product
    MAX Brand SUPER SELENIUM 250, 180 Count Tablets Product labeling reads in part:"MAX SUPER SELENIUM 250 ***Dietary Supplement 180 Tablet***0 65176 06756 1***Manufactured in FDA Approved Facility For:HealthMax Products Co. Altadena, CA 91001***".
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1955-2013·2013-10-02

    Blythedale Farm Vermont Brie Recalled for Inadequate Pasteurization

    Blythedale Farm Inc. is recalling 11,678 units of Vermont Brie due to inadequate pasteurization. The product was distributed in 10 states and DC.

    Product
    Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1946-2013·2013-10-02

    Irene's Black & White Cookies Recalled for Undeclared Milk Allergen

    Irene's Bakery is recalling Black & White Cookies because they contain undeclared whey powder, a milk allergen, in the chocolate coating.

    Product
    Irene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bi
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2274-2013·2013-10-02

    BD Recalls Epilor Syringes Due to Plunger Sticking Hazard

    Becton Dickinson is recalling BD Epilor syringes because the plunger may stick, preventing users from detecting loss of resistance during epidural procedures.

    Product
    BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Food)·F-1950-2013·2013-10-02

    Snoqualmie Falls Candy Factory Recalls Pecan Brittle for Milk Allergen Mislabeling

    Snoqualmie Falls Candy Factory is recalling Pecan Brittle because the label declares butter or cream but fails to list milk as an ingredient.

    Product
    Pecan Brittle's label is read in parts: "***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1944-2013·2013-10-02

    American Nut Company Recalls Mixed Nuts for Undeclared Wheat Allergen

    American Nut Company is recalling specific 25-pound mixed nut products because they may contain undeclared wheat, a major food allergen.

    Product
    Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2285-2013·2013-10-02

    CareFusion Recalls SmartSite Infusion Sets Due to Tubing Separation Risk

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the tubing sleeve may separate below the drip chamber.

    Product
    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1948-2013·2013-10-02

    Semifreddi's Chocolate Dipped Almond Biscotti Recalled for Undeclared Allergens

    Semifreddi's Inc. is recalling Chocolate Dipped Almond Biscotti due to undeclared milk and soy allergens in ingredients.

    Product
    Chocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with "Enjoy By" dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product Size and UPC codes: 0.65 oz., case of 100 units 758843915943 0.89 oz., tub of 22 units 758843916001 1.3
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2271-2013·2013-10-02

    Stryker Vision Mounting Arm Recalled Due to Display Detachment Risk

    Stryker Endoscopy is recalling 14,271 Vision Mounting Arms because excessive force can cause the display to detach and fall on users or patients.

    Product
    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Food)·F-1953-2013·2013-10-02

    Snoqualmie Falls Candy Factory Recalls Coconut Brittle Due to Undeclared Milk

    Snoqualmie Falls Candy Factory is recalling Coconut Brittle because the label lists butter and cream but omits milk, a major allergen.

    Product
    Coconut Brittle's is labeled in parts: "***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, butter (cream, salt), vanilla, salt***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1911-2013·2013-10-02

    Spartan Fresh Selections American Potato Salad Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Spartan Fresh Selections American Potato Salad due to potential Listeria monocytogenes contamination.

    Product
    spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2265-2013·2013-10-02

    Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw

    Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.

    Product
    ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2263-2013·2013-10-02

    Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect

    Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.

    Product
    Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-criti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2013·2013-10-02

    Elekta Recalls Monaco RTP System Radiation Therapy Treatment Planning System

    Elekta, Inc. is recalling 72 units of the Monaco RTP System Radiation Therapy Treatment Planning System because patients must be positioned as indicated by the treatment plan.

    Product
    Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2275-2013·2013-10-02

    Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button

    Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.

    Product
    TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.co
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2282-2013·2013-10-02

    Synthes Oracle Spacer System Slap Hammer Recalled for Breakage During Use

    Synthes USA HQ, Inc. is recalling 27 units of the Oracle Spacer System Slap Hammer because the proximal end broke during use.

    Product
    Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combi
    Category
    Medical Device
    Distribution
    5 states

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