The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
140
High
292
Moderate
204
Low
34

Of the 688 recalls this month scored against our rubric, 3% are Critical, 20% are Severe.

401–500 of 688

  • SevereNHTSA·14V425000·2014-07-14

    Aston Martin Recalls 2014 DB9 and Rapide S for Transmission Defect

    Aston Martin is recalling 440 model year 2014 DB9 and Rapide S vehicles because a faulty circuit board may cause the transmission to shift to neutral without driver input.

    Product
    ASTON MARTIN — ASTON MARTIN DB9, RAPIDE S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V422000·2014-07-14

    BMW Recalls 2014 i3 and MINI Cooper for Air Bag Defect

    BMW is recalling certain 2014 i3 and MINI Cooper vehicles because the front passenger air bag inflator may not be assembled correctly, potentially preventing proper deployment in a crash.

    Product
    BMW — BMW, MINI I3, COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E040000·2014-07-14

    PACCAR Recalls Mirrex and TRP Warning Triangle Kits for Missing Markings

    PACCAR is recalling aftermarket Mirrex and TRP warning triangle kits sold between 2009 and 2014 because they lack required manufacturer markings, failing to meet federal safety standards.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E038000·2014-07-11

    Tucker Rocky Recalls Cyber River Road Grateful Dead U-6 Motorcycle Helmets

    Tucker Rocky is recalling specific Cyber River Road Grateful Dead U-6 motorcycle helmets because they failed federal safety impact tests. Owners should contact the company for a free replacement.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E037000·2014-07-10

    Airtex E84070 Replacement Fuel Pumps Recalled for Leak Risk

    UCI-Fram Group is recalling Airtex E84070 replacement fuel pumps shipped between December 2013 and June 2014 due to a seal defect that may cause fluid leaks and increase fire risk.

    Product
    FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14228·2014-07-10

    Gemini Recalls Power Adaptor Chargers Due to Burn Hazard

    Gemini is recalling about 31,000 promotional power adaptors/chargers because they can overheat and cause burns. Consumers should stop using and dispose of the units.

    Product
    Power adaptor/chargers (promotional giveaway)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V426000·2014-07-10

    Roush Recalls 2010-2012 Ford E-Series Vans Due to Propane Leak Risk

    Roush is recalling 2010-2012 Ford E-Series vans with specific propane conversion kits due to a potential fuel leak that could cause a fire.

    Product
    FORD — FORD E-250, E-350, E-150, E-450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V419000·2014-07-10

    Nissan Recalls 2014 NV Vans Due to Seat Belt Bolt Defect

    Nissan is recalling 2014 NV vans because seat belt retractor bolts may be loose or missing, potentially compromising occupant restraint in a crash.

    Product
    NISSAN — NISSAN NV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14226·2014-07-10

    Lifeguard Press Recalls Charging Kits Due to Fire and Shock Hazards

    Lifeguard Press is recalling about 25,400 charging kits sold at Dillard's, Lilly Pulitzer, and Nordstrom's because the wall chargers can overheat, spark, or detach prongs, posing fire and shock risks.

    Product
    Charging Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2079-2014·2014-07-09

    Rome Packing Recalls Ocean's Catch Crabmeat Due to Listeria Contamination

    Rome Packing Co., Inc. is recalling Ocean's Catch Ready-to-Eat Fresh Hand Picked Crabmeat because it is contaminated with Listeria monocytogenes.

    Product
    Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2081-2014·2014-07-09

    Rome Packing Recalls Jonah Crab Meat Contaminated with Listeria

    Rome Packing Co. is recalling 300 lbs of Ocean's Catch Jonah Crab Minced Meat contaminated with Listeria monocytogenes. The product was distributed in six states.

    Product
    Ocean's Catch Jonah Crab Minced Meat Crabmeat , Net WT. 10 lb. plastic bag
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-2080-2014·2014-07-09

    Rome Packing Recalls Jonah Crab Meat Due to Listeria Contamination

    Rome Packing Co. is recalling Ocean's Catch Jonah Crab Meat contaminated with Listeria monocytogenes. Consumers should check lot numbers and discard or return affected products.

    Product
    Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container Ingredients; Contains Jonah Rock Crab Meat, Salt
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-2077-2014·2014-07-09

    Olde Thompson Recalls Kirkland Signature Coarse Ground Malabar Black Pepper

    Olde Thompson is recalling Kirkland Signature Coarse Ground Malabar Black Pepper due to potential Salmonella contamination. The product was distributed nationwide in the US and in Canada.

    Product
    Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998. Packaging includes a PET bottle. The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1988-2014·2014-07-09

    GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.

    Product
    GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-2056-2014·2014-07-09

    Whole Foods Recalls Fresh Wild Gulf Amberjack Due to Illness Complaints

    Whole Foods Market South Seafood Distribution is recalling fresh wild Gulf Amberjack in Georgia after receiving complaints of illness from consumers.

    Product
    Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2057-2014·2014-07-09

    Lao Thai Nam Salted Fish Recalled for Botulism Risk

    Lao Thai Nam Corporation is recalling 120 packs of Number One Sompa Salted Fish due to potential Clostridium botulinum contamination. The product was distributed in Texas.

    Product
    Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1991-2014·2014-07-09

    Siemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur TnI-Ultra assay kits because a darker solid phase reagent in some lots may lead to incorrect test results.

    Product
    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2014·2014-07-09

    Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk

    Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.

    Product
    Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1989-2014·2014-07-09

    GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk

    GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.

    Product
    GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose dia
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1985-2014·2014-07-09

    Siemens Mobilett XP X-ray System Recalled for Fire Hazard

    Siemens is recalling 10 Mobilett XP Digital Mobile X-ray Systems due to a potential fire hazard from Lithium-Ion batteries installed between October 2010 and April 2011.

    Product
    Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-5060-2014·2014-07-09

    HK Galleria Recalls Rice Porridge with Abalone Due to Botulism Risk

    HK Galleria Wholesale is recalling Yangban Rice Porridge with Abalone because it may be contaminated with Clostridium botulinum.

    Product
    Yangban Rice Porridge with Abalone, Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1959-2014·2014-07-09

    Atrium Express Dry Seal Chest Drain Recall Due to Leaking Risk

    Atrium Medical Corporation is recalling 1,170 units of the Express Dry Seal Chest Drain ATS Blood Recovery because the tubing may leak or disconnect.

    Product
    Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N. Autotransfusion Apparatus.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-2074-2014·2014-07-09

    Parkers Farm Recalls Hot Salsa Due to Listeria Contamination Risk

    Parkers Farm is recalling 16-ounce Hot Salsa containers in several states as a precaution due to potential Listeria monocytogenes contamination.

    Product
    Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2075-2014·2014-07-09

    Parkers Farm Fire Roasted Salsa Recalled for Listeria Risk

    Parkers Farm is recalling Fire Roasted Salsa due to potential Listeria monocytogenes contamination identified by Minnesota Department of Agriculture testing.

    Product
    Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2073-2014·2014-07-09

    Parkers Farm Recalls Mild Salsa for Potential Listeria Contamination

    Parkers Farm is recalling 1,264 cases of Mild Salsa due to potential Listeria monocytogenes contamination identified during testing by the Minnesota Department of Agriculture.

    Product
    Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2063-2014·2014-07-09

    Jardine Foods Recalls Queso Loco Dip Due to Undeclared Wheat

    Jardine Foods is recalling 14,200 jars of Queso Loco dip because it contains undeclared wheat. The product was distributed in Texas and Canada.

    Product
    DL Jardines Queso Loco (Item#R5230) ; Label: Special Edition D. L. Jardine's Texas Ranch Recipes Queso Loco Cheese Salsa & Dip; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1931-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1952-2014·2014-07-09

    Medical Action Industries Recalls Sterile Suture Sets Due to Seal Defects

    Medical Action Industries is recalling sterile suture sets because incomplete seals may compromise sterility. The recall involves 474 cases distributed across 15 states.

    Product
    Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1955-2014·2014-07-09

    Medical Action Industries Recalls Safety Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling Safety Laceration Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1979-2014·2014-07-09

    Nihon Kohden CNS-6201 Central Nurse Station Software Recall

    Nihon Kohden is recalling CNS-6201 Central Nurse Stations with software version 02-26 due to unexpected reboots that interrupt patient data display and alarms.

    Product
    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1983-2014·2014-07-09

    Anspach Pneumatic and Electric Motor Systems Recalled for Sterility Assurance Failures

    The Anspach Effort, Inc. is recalling 115,988 pneumatic and electric motor systems because certain attachments failed to meet sterility assurance levels during sterilization.

    Product
    Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Food)·F-2068-2014·2014-07-09

    Rite Aid Recalls Thrifty Mint 'N' Chip Ice Cream Due to Undeclared Pistachio

    Rite Aid is recalling 560 pints of Thrifty Mint 'N' Chip ice cream because pistachio was inadvertently packed into the containers without being declared on the label.

    Product
    waxed paperboard int container of frozen ice cream labeled Thrifty Ice Cream Mint 'N' Chip 1 Pint (16 Fl. OZ.) Bottom of container Expiration Date: October 28 2015 Lot #24273 Back of container UPC 1182264327
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1956-2014·2014-07-09

    McKesson Medi-Pak Laceration Trays Recalled for Incomplete Sterile Seals

    Medical Action Industries is recalling 474 cases of McKesson Medi-Pak Laceration Trays because some sterile kits may have incomplete seals that could compromise sterility.

    Product
    McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1921-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathe
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2078-2014·2014-07-09

    Dole Garden Soup Recalled for Undeclared Milk Allergen

    Dole Packaged Foods is recalling Roasted Garlic Tomato Basil soup because it contains undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Dole Garden Soup "Roasted Garlic Tomato Basil", Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1920-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathe
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1981-2014·2014-07-09

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.

    Product
    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1947-2014·2014-07-09

    Alcon Anterior Chamber Cannula Recall Due to Incorrect Component

    Alcon is recalling CUSTOM-PAKs that contain a sharp tip needle instead of the intended anterior chamber cannula.

    Product
    Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2072-2014·2014-07-09

    Parkers Farm Recalls Horseradish Cold Pack Cheese for Listeria Risk

    Parkers Farm is recalling specific pails of Horseradish Cold Pack Cheese due to potential Listeria monocytogenes contamination identified during state testing.

    Product
    Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid (42550); 2. Cobblestone Market in 5 lb. pail pails with snap on lid (42603).
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1961-2014·2014-07-09

    Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment

    Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.

    Product
    MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-2053-2014·2014-07-09

    Baptista's Bakery Recalls Gluten-Free Crackers Due to Salmonella Risk

    Baptista's Bakery is recalling specific lots of Rosemary & Olive Oil Gluten Free Snack Crackers because a seasoning supplier's blend may be contaminated with Salmonella.

    Product
    Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes: 1. glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861; 2. glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863; 3. Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1951-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration and suture removal kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2064-2014·2014-07-09

    Jardine Foods Recalls Mi Queso, Su Queso for Undeclared Wheat

    Jardine Foods Inc. is recalling 6,233 jars of Mi Queso, Su Queso because a supplier accidentally used wheat instead of whey in the cheese premix.

    Product
    Mi Queso, Su Queso (Item#50440) ; Label: Jardine's 7J Ranch Mi Queso, Su Queso; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1990-2014·2014-07-09

    Siemens MicroScan WalkAway Plus Instruments Recalled for Hinge Spring Failure

    Siemens is recalling MicroScan WalkAway-40 and 96 plus instruments because springs in the access door hinge assembly are detaching, causing premature failure and potential safety issues.

    Product
    MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2062-2014·2014-07-09

    Jardines 7J Queso Amarillo Recalled for Undeclared Wheat

    Jardine Foods is recalling 9,649 jars of 7J Queso Amarillo due to undeclared wheat. The product was distributed in Texas and Canada.

    Product
    Jardines 7J Queso Amarillo (Item#50100) ; label: Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2069-2014·2014-07-09

    Parkers Farm Recalls Sharp Cheddar Cheese for Listeria Contamination

    Parkers Farm is recalling Sharp Cheddar Cold Pack Cheese and salsa products due to potential Listeria monocytogenes contamination.

    Product
    Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2. Central Markets in 8 oz cups with snap on lid (27
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2071-2014·2014-07-09

    Parkers Farm Recalls Cheddar Cheese for Listeria Contamination Risk

    Parkers Farm is recalling Olivia Swan Cheddar Cold Pack Cheese due to potential Listeria monocytogenes contamination identified during state testing.

    Product
    Olivia Swan Cheddar Cold Pack Cheese 10 lb. pail with snap on lid (12341os)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2052-2014·2014-07-09

    Savor Brands Large Pitted Kalamata Olives Recalled Due to Glass Contamination

    Dot Foods Inc. is voluntarily recalling Savor Brands Large Pitted Kalamata Olives because they may contain glass.

    Product
    Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1953-2014·2014-07-09

    Medical Action Industries Recalls Port-A-Cath Trays Due to Seal Defects

    Medical Action Industries is recalling Port-A-Cath Trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2070-2014·2014-07-09

    Parkers Farm Recalls Port Wine Cold Pack Cheese for Listeria Risk

    Parkers Farm is recalling Port Wine Cold Pack Cheese and salsa products due to potential Listeria monocytogenes contamination identified during testing.

    Product
    Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), and 5 lb. (11951) white tub with snap on lid; 2. 150+Central Markets in 8 oz cups with snap on lid (27057). 3. Cobblestone Market in
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1950-2014·2014-07-09

    Medical Action Industries Recalls Sterile Laceration Trays Due to Seal Defects

    Medical Action Industries is recalling sterile laceration trays because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2065-2014·2014-07-09

    Jardine Foods Recalls HT Traders Medium Queso Due to Undeclared Wheat

    Jardine Foods is recalling HT Traders Medium Queso because a supplier accidentally used wheat instead of whey in the cheese premix.

    Product
    HT Traders Medium Queso (Item#HT510) ; Label: Medium Queso; Premium Salsa; Net Wt. 16 oz. Distributed by Harris Teeter, Matthews, NC
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2066-2014·2014-07-09

    Jardine Three Compadres Gift Box Recalled for Undeclared Wheat

    Jardine Foods Inc. is recalling Three Compadres Gift Boxes because a supplier accidentally used wheat instead of whey in the cheese premix, creating an undeclared wheat allergen.

    Product
    Three Compadres Gift Box containing a varying combination of three Jardine products in 16 oz. glass jars. Some Gift Boxes included one jar of either Jardine's 7J Ranch Mi Queso, Su Queso (See Product #3) or one jar of Queso Loco Cheese Salsa & Dip (See Product #2)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2076-2014·2014-07-09

    Parkers Farm Garlic Salsa Recalled for Potential Listeria Contamination

    Parkers Farm Inc. is recalling 16-ounce containers of Garlic Salsa due to potential Listeria monocytogenes contamination. The recall is a precautionary measure following testing by the Minnesota Department of Agriculture.

    Product
    Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1924-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subar
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1963-2014·2014-07-09

    Baxter Exactamix Compounder Recall Due to Software Configuration Error

    Baxter Healthcare is recalling Exactamix 1200 and 2400 Compounders because a software error may prevent pump tube flushing, risking cross-contamination of IV solutions.

    Product
    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds mu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2014·2014-07-09

    Ventlab Manual Resuscitator Bags Recalled Due to Valve Defect

    Ventlab LLC is recalling 251,384 manual resuscitator bags because a defective pop-off valve may prevent air delivery during emergency resuscitation.

    Product
    Manual Resuscitator Bag Series: AF1000, AF2000, AF3000, AF4000, AF5000, BT2000, BT3000, BT4000, BT5000, BVM700, CPRM1000, CPRM2000, CPRM3000, PRO-1900, PRO-1000, PRO-2000, SC7000, SC8000, SC8020, SC8120, SC9000, SS3200, VN2000, VN3000, VN4000, VN5000, VT1000 , VN2102, VN2002.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1957-2014·2014-07-09

    Medical Action Industries Recalls Laceration Kits Due to Seal Defects

    Medical Action Industries is recalling sterile laceration kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1923-2014·2014-07-09

    Medtronic Duet External Drainage System Tubing Disconnection Recall

    Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

    Product
    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1940-2014·2014-07-09

    Global Cooling Stirling Ultracold Portable Shuttle Recalled for Overheating

    Global Cooling Inc is recalling 413 Stirling Ultracold Portable Shuttle units because the external power supply input overheats at the connection to the freezer.

    Product
    Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-1944-2014·2014-07-09

    Siemens syngo Lab Data Manager Software Recall for Configuration Errors

    Siemens is recalling syngo Lab Data Manager software because configuration errors may cause test results to bypass manual review and release to the Laboratory Information System.

    Product
    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2014·2014-07-09

    Medical Action Industries Recalls Max Barrier Kits Due to Seal Defects

    Medical Action Industries is recalling Max Barrier Kits because incomplete seals may compromise sterility. The recall affects 474 cases distributed across 15 states.

    Product
    Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1938-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1965-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Endowrist Instrument Manuals

    Intuitive Surgical is recalling Endowrist Instrument and Accessory Manuals for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.

    Product
    Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1966-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Vision Troubleshooting Guides

    Intuitive Surgical is recalling Vision Troubleshooting Guides for the da Vinci Surgical System to remove references to the Emergency Grip Release Wrench.

    Product
    Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

    Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from instructions.

    Product
    IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2014·2014-07-09

    Meridian Bioscience Recalls illumipro-10 Incubator/Reader Units for Calibration Issues

    Meridian Bioscience is recalling 35 illumipro-10 incubator/reader units because Block B chambers may operate at incorrect temperatures due to calibration errors.

    Product
    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1935-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1416-2014·2014-07-09

    Mometasone Irrigation Solution Recalled for Incorrect Solvent

    MD Custom Rx is recalling Mometasone irrigation solution compounded with an incorrect solvent. The product was distributed in Wisconsin.

    Product
    Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1418-2014·2014-07-09

    MD Custom Rx Recalls HCG Drops Due to Incorrect Solvent

    MD Custom Rx is recalling HCG drops compounded with an incorrect solvent. The recall is limited to Wisconsin.

    Product
    HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1945-2014·2014-07-09

    Baxter MiniCap Dialysis Pouch Packaging Adhesion Defect Recall

    Baxter Healthcare is recalling MiniCap dialysis pouches because the paper layer may not be fully adhered to the foil, potentially compromising the protective barrier.

    Product
    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-2061-2014·2014-07-09

    National Vitamin Recalls Ferrous Gluconate Tablets Due to Mislabeled Iron Content

    National Vitamin Co Inc is recalling Nature's Blend Ferrous Gluconate Tablets because the front panel incorrectly lists 65 mg of elemental iron instead of the correct 36 mg.

    Product
    Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2014·2014-07-09

    Blue Belt Technologies Recalls Mislabeled Stride Unicondylar Knee Prosthesis Components

    Blue Belt Technologies is recalling specific lots of Stride unicondylar knee prosthesis femoral components due to packaging mislabeling that may result in the wrong implant being used.

    Product
    Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1413-2014·2014-07-09

    Baxter Recalls Brevibloc Injection Due to Particulate Matter

    Baxter Healthcare is recalling Brevibloc (esmolol hydrochloride) injection due to complaints of discolored solution and subvisible iron oxide particles.

    Product
    BREVIBLOC — BREVIBLOC (ESMOLOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci System Manuals Due to Wrench Removal

    Intuitive Surgical is recalling da Vinci Surgical System manuals and guides to remove references to the Emergency Grip Release Wrench.

    Product
    System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2014·2014-07-09

    Intuitive Surgical Recalls Cautery QRG for da Vinci Surgical Systems

    Intuitive Surgical is recalling Cautery Quick Reference Guides for da Vinci systems to update documentation and remove a specific wrench part.

    Product
    Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1974-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

    Intuitive Surgical is recalling Quick Reference Guides for the da Vinci Surgical System to remove the Emergency Grip Release Wrench from the documentation.

    Product
    Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1960-2014·2014-07-09

    Siemens ADVIA Centaur HCY Diluent Recalled for Inaccurate Dilution Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HCY Diluent because dilution recovery was lower than reported in the instructions for use.

    Product
    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1962-2014·2014-07-09

    Siemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error

    Siemens Medical Solutions is recalling ACUSON S Family ultrasound systems due to a potential measurement error in the Auto-Stats tool.

    Product
    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1958-2014·2014-07-09

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is correcting labeling for 614 Simplexa Flu A/B & RSV Direct kits due to sporadic false signals that may increase false results.

    Product
    Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413  Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1975-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Quick Reference Guides

    Intuitive Surgical is recalling Natural Rubber Latex Quick Reference Guides for the da Vinci Surgical System to update documentation and remove a specific wrench part.

    Product
    Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2054-2014·2014-07-09

    Physique Enhancing Science Recalls ALPHAMINE Powder Due to Unapproved Ingredient

    Physique Enhancing Science is recalling ALPHAMINE thermogenic powder because it contains Aegeline, an unapproved new dietary ingredient.

    Product
    Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2059-2014·2014-07-09

    Brunkow Monterey Jack Cheese Recalled for Mushroom Mislabeling

    Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom & Onion Cheese because it contains a different type of mushroom than listed on the label.

    Product
    Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed. Eight blocks per case. Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1419-2014·2014-07-09

    FDA Recalls HCG Tablets Compounded With Incorrect Solvent

    FDA is recalling HCG 125U/Tab Tablet Tritu compounded by MD Custom Rx due to the use of an incorrect solvent.

    Product
    HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state

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