The Recall Desk

Archive

June 2012 recalls

351 recalls were announced in June 2012.

What the numbers show

Critical
12
Severe
110
High
152
Moderate
65
Low
12

Of the 351 recalls this month scored against our rubric, 3% are Critical, 31% are Severe.

101–200 of 351

  • HighFDA (Food)·F-1491-2012·2012-06-27

    Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling lactic acid products contaminated with metal fragments. The recall covers 41 bags distributed across 15 US states, Canada, and Chile.

    Product
    Kerry, NO MSG CHED SC SEAS 01113, CONTAINS MILK, Item # 720061.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1816-2012·2012-06-27

    Stryker Accolade Offset Rasp Handle Recalled for Potential Fracture

    Stryker Howmedica Osteonics is recalling 41 Accolade Offset Rasp Handles due to a potential risk of fracturing during use in total hip arthroplasty.

    Product
    Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1502-2012·2012-06-27

    Kerry Foods Recalls Buffalo Wing Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling Buffalo Wing Seasoning because it is contaminated with metal fragments.

    Product
    KERRY, BUFFALO WING SEASONING , Item # I10256.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1484-2012·2012-06-27

    Kerry Foods Recalls Lasagna Seasoning Contaminated with Metal Fragments

    Kerry Foods is voluntarily recalling Lasagna Sklt Seas 10078 due to contamination with metal fragments. The product was distributed in 15 US states and two countries.

    Product
    KERRY, LASAGNA SKLT SEAS 10078, SE10078, CONTAINS MILK, Item # I10078.859, Net Wt 1600 Lb (725.69Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1495-2012·2012-06-27

    Kerry Foods Recalls Cheddar Broccoli Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling Cheddar Broccoli Seasoning because it is contaminated with metal fragments.

    Product
    KERRY, CHEDDAR BROCCOLI SEAS S25CBROC, CONTAINS MILK, Item # 720175.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1519-2012·2012-06-27

    Kerry Foods Recalls Cheeseburger Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling cheeseburger seasoning products contaminated with metal fragments. The recall covers specific states in the US and international markets.

    Product
    KERRY, CHEESEBURGER SEAS 8543, S20C3, CONTAINS MILK,WHEAT , Item #I8543.465 , Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1480-2012·2012-06-27

    Kerry Cheddar Cheese Recalled Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Cheddar Cheese products contaminated with metal fragments. The recall affects specific lots distributed in the US and Canada.

    Product
    KERRY, CHEDDAR CHEESE, CONTAINS MILK, 701183, R-SE-0056 , Item Number 701183.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1525-2012·2012-06-27

    Kerry Foods Recalls Hot Cheese Products Due to Metal Fragments

    Kerry Foods is voluntarily recalling specific hot cheese products because they are contaminated with metal fragments.

    Product
    KERRY, HOT CHEESE, SEAS, 04-20200, CONTAINS MILK , Item #I10185.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1833-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that can be dislodged.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that could dislodge during use.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MARKING, 10" (25 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1485-2012·2012-06-27

    Kerry Foods Recalls Cheddar and Sour Cream Products Due to Metal Fragments

    Kerry Foods is voluntarily recalling specific lots of Cheddar & Sour Cream products because they are contaminated with metal fragments.

    Product
    KERRY, CHEDDAR & SOUR CREAM 1037, CONTAINS MILK, Item # 717519.360, Net Wt 25 Lb (11.34Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1441-2012·2012-06-27

    Ocean Group Recalls IQF Oysters Due to Insanitary Conditions

    Ocean Group Inc. is recalling IQF oysters from Korea because they were prepared or packed under insanitary conditions, posing a potential health risk.

    Product
    Large IQF Oysters, 6 x 4 lb/cs
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1489-2012·2012-06-27

    Kerry Foods Recalls Sour Cream Chives Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Sour Cream Chives products because they are contaminated with metal fragments.

    Product
    KERRY, SOUR CR 7 CHIVES 718948, S37ASC, CONTAINS MILK, WHEAT, Item # 718948.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1832-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1483-2012·2012-06-27

    Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling lactic acid products contaminated with metal fragments. The affected items were distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, PARM. LING. 5734, SEA 5734, CONTAINS MILK, Item # 15734.607, , Net Wt 1000 Lb (453.556 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1499-2012·2012-06-27

    Kerry Foods Recalls Stroganoff Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Stroganoff Seasoning because it is contaminated with metal fragments. The product was distributed in 15 US states and two countries.

    Product
    KERRY, STROGANOFF SEAS 10079 SE10079, CONTAINS MILK, WHEAT, Item # I10079.859, Net Wt 1600 Lb (725.69 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1510-2012·2012-06-27

    Kerry Foods Recalls Bacon Ranch Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling Bacon Ranch Seasoning because it is contaminated with metal fragments. The product was distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, BACON RANCH SEAS 723951 S57RB, CONTAINS MILK, Item # 723951.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1527-2012·2012-06-27

    Kerry Foods Recalls Cheese Blend Contaminated with Metal Fragments

    Kerry Foods is voluntarily recalling specific lots of Cheese Blend 862B because the product is contaminated with metal fragments.

    Product
    KERRY, CHEESE BLEND 862B , CONTAINS MILK Item # I2065.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1828-2012·2012-06-27

    Biomet 3i Recalls Dental Implants Due to Missing Internal Thread

    Biomet 3i is recalling specific Osseotite dental implants because they may lack an internal thread. The recall affects 219 units distributed in the US and internationally.

    Product
    Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that can be dislodged.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connector surface can be dislodged during use.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1834-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that could be dislodged.

    Product
    SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 11" (28 CM) LONG, WITH XCOATING SURFACE COATING. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1456-2012·2012-06-27

    Aldi Northern Catch Oysters Recalled for Norovirus Contamination

    Camerican International is recalling Aldi-branded oysters due to norovirus contamination and insanitary conditions.

    Product
    Northern Catch Fancy Whole Oysters Net Wt. 8 OZ (227g) Distributed by the Aldi Inc., Batavia, IL 60510 Product of Korea
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2012·2012-06-27

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.

    Product
    SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE RING, 9.5" (24 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.

    Product
    CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1526-2012·2012-06-27

    Kerry Foods Recalls Nacho Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling specific lots of nacho seasoning because they are contaminated with metal fragments.

    Product
    KERRY, NACHO SEASONING 717379, 04-20200, CONTAINS MILK , SOY, Item # 717379.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1496-2012·2012-06-27

    Kerry Foods Recalls Creamy Garlic Product Due to Metal Fragments

    Kerry Foods is voluntarily recalling Creamy Garlic products contaminated with metal fragments. The affected items were distributed in 15 US states and two countries.

    Product
    KERRY, CREAMY GARLIC 720721 S25CG, CONTAINS MILK, SOY, WHEAT, Item # 720721.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1492-2012·2012-06-27

    Kerry Foods Recalls Parmesan Blend Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Parmesan Blend products because they are contaminated with metal fragments. The affected items were distributed in 15 US states and two countries.

    Product
    Kerry, PARMESAN BLEND 720068 CH720068, CONTAINS MILK, WHEAT, Item # 720068.607, Net Wt 1000 Lb (453.556 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1453-2012·2012-06-27

    Casa de Mesquite Mesquite Bean Flour Recalled for Bacillus Cereus Contamination

    Casa de Mesquite is recalling specific lots of Mesquite Bean Flour due to potential contamination with Bacillus cereus, a spoilage organism that can cause gastrointestinal symptoms.

    Product
    Casa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1530-2012·2012-06-27

    Kerry Foods Recalls Jalapeno Cheddar Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Jalapeno Cheddar cheese because it is contaminated with metal fragments. The affected product was distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, JALAPENO CHEDDAR 16975, GCAS# 95546689, CONTAINS MILK, Item # B16975.01, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1500-2012·2012-06-27

    Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling lactic acid-containing products because they are contaminated with metal fragments. The recall affects specific states in the US and Canada.

    Product
    KERRY, NACHO SEAS NAT, CONTAINS MILK, Item # 721108.465, Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1516-2012·2012-06-27

    Kerry Foods Recalls Roasted Garlic Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Roasted Garlic Seasoning because it is contaminated with metal fragments. The product was distributed in 15 US states and two countries.

    Product
    KERRY, ROASTED GARLIC SEAS 10112, S37RG2 , CONTAINS MILK, SOY, Item # I10112.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1839-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.

    Product
    24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2012·2012-06-27

    Medtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues

    Medtronic is recalling three 0-arm Imaging Systems because software version 3.1.1 does not meet navigational accuracy standards.

    Product
    Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2012·2012-06-27

    Natus Olympic Cool-Cap System Recalled Due to Power Supply Failure

    Natus Medical is recalling 181 Olympic Cool-Cap Systems because the power supply may fail without warning, interrupting cooling treatment for infants.

    Product
    Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2012·2012-06-27

    Philips Easy Diagnost Fluoroscopic System Recalled for Measurement Errors

    Philips Healthcare Inc. is recalling six Easy Diagnost stationary fluoroscopic systems because misaligned lead rulers can cause incorrect distance measurements, potentially affecting surgical interventions.

    Product
    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1778-2012·2012-06-27

    Nidek Medical NUVO LITE Oxygen Concentrator Recalled for Fire Hazard

    Nidek Medical is recalling 730 NUVO LITE oxygen concentrators because a capacitor failure could cause a fire or loss of oxygen.

    Product
    NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1508-2012·2012-06-27

    Kerry Foods Recalls Stroganoff Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling Stroganoff Seasoning because it is contaminated with metal fragments. The product was distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, STROGANOFF SEAS 722920 SE722920, CONTAINS MILK, WHEAT, Item # 722920.859, Net Wt 1600 Lb (725.69 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1855-2012·2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect

    Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.

    Product
    seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2012·2012-06-27

    Kerry Foods Recalls 4 Cheese Seasoning Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling 4 Cheese Seasoning products because they are contaminated with metal fragments. The affected items were distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1817-2012·2012-06-27

    American Optisurgical Recalls TX1 Tissue Removal System Consoles

    American Optisurgical Inc is recalling five TX1 Tissue Removal System Consoles due to an incorrect pressure relief valve and inaccurate technical specifications.

    Product
    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2012·2012-06-27

    Philips Digital Diagnost Software Recall for Image Marker Error

    Philips Healthcare Inc. is recalling Digital Diagnost Software releases 2.0.2 and 2.0.2SP1 because a mirrored image marker can be mistaken for a right-side patient indicator.

    Product
    Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2012·2012-06-27

    FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2012·2012-06-27

    Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk

    Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.

    Product
    seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1840-2012·2012-06-27

    Terumo Recalls Sarns High-Flow Aortic Arch Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.

    Product
    SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2012·2012-06-27

    FDA Recalls Covidien Roticalutor Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien Roticalutor 30-V3 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2012·2012-06-27

    Boston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty

    Boston Scientific is recalling 1,340 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1529-2012·2012-06-27

    Kerry Foods Recalls Cheesy Cheddar Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling Cheesy Cheddar Seasoning because the product is contaminated with metal fragments.

    Product
    KERRY, CHEESY CHEDDAR SEAS I10103, CONTAINS MILK, SOY, Item # I10103.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1503-2012·2012-06-27

    Kerry Recalls Cultured Buttermilk Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling specific lots of cultured buttermilk because they are contaminated with metal fragments.

    Product
    KERRY, CULTURED NF BUTTERMILK 986, CODE 031001.010, CONTAINS MILK, Item # I2868.465 , Net Wt 50 Lb (22.68 Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1517-2012·2012-06-27

    Kerry Foods Recalls Double Cheeseburger Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling Double Cheeseburger Seasoning because it is contaminated with metal fragments. The product was distributed in 15 US states and two countries.

    Product
    KERRY, DOUBLE CHEESEBURGER SEAS 8917 , S20DC, CONTAINS MILK, WHEAT, Item #I8917.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1533-2012·2012-06-27

    Kerry Foods Recalls Broccoli and Cheese Seasoning Due to Metal Fragments

    Kerry Foods is voluntarily recalling broccoli and cheese seasoning products contaminated with metal fragments. The affected items were distributed in 15 US states and two countries.

    Product
    KERRY, PL BROC & CHEESE SEAS 8893 , CONTAINS MILK, WHEAT, Item # I8893.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • HighCPSC·12207·2012-06-27

    Big Cat Recalls Musashi Recumbent Bicycles Due to Frame Crack Hazard

    Big Cat Human Powered Vehicles is recalling about 170 Catbike Musashi recumbent bicycles because the frame can crack, causing the rider to lose control and crash.

    Product
    Catbike Musashi recumbent bicycle
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1455-2012·2012-06-27

    FDA Recalls Korean Whole Oysters in Water Due to Norovirus Risk

    Camerican International is recalling Ralph's and Kroger brand whole oysters in water nationwide due to potential norovirus contamination and insanitary conditions.

    Product
    Whole Oysters in Water under the following brand names: 1) Ralph's Whole Oysters in Water, Net Wt. 8 OZ (226 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Kroger Whole Oysters in Water Net Wt. 8 OZ (226g) Distributed by the Kroger Co., C
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1531-2012·2012-06-27

    Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling lactic acid products contaminated with metal fragments. The affected items were distributed to specific US states and international locations.

    Product
    KERRY, CHEZ-TONE 6313, QO-05424 / QO-2200542400, CONTAINS MILK, Item # I6313.465, Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1634-2012·2012-06-27

    Shiitake-Ya Dried Mushroom Slices Recalled for Pesticide Residues

    LA Link Corporation is recalling Shiitake-Ya Dried Shiitake mushroom slices because FDA testing found pesticide and polycyclic aromatic hydrocarbon residues with no established tolerances.

    Product
    Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) I
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1451-2012·2012-06-27

    Reese Medium Smoked Oysters Recalled Due to Norovirus Risk

    World Finer Foods is recalling Reese Medium Smoked Oysters due to inadequate sanitation controls that may have exposed the product to human fecal waste and norovirus.

    Product
    Reese Medium Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00600.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1811-2012·2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.

    Product
    PrepStain Syringing Pipettes 240 (Catalog #490517)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1458-2012·2012-06-27

    Pr Supplies Co. Recalls Queso del Pais Pasta y Queso Guayaba

    Pr Supplies Co. is recalling Queso del Pais Pasta y Queso Guayaba after state sampling found Clostridium Clostridioforme.

    Product
    "***Queso del Pais***TRIDAS***Pasta y Queso "Guayaba"***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1850-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a thre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1459-2012·2012-06-27

    Pr Supplies Co. Recalls Queso del Pais Pasta y Queso Mango

    Pr Supplies Co. is recalling 100 units of Queso del Pais Pasta y Queso Mango in Puerto Rico due to positive Clostridium Clostridioforme test results.

    Product
    "***Queso del Pais***TRIDAS***Pasta y Queso "Mango"***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1387-2012·2012-06-27

    Kutol Hands Down Medicated Lotion Soap Recalled for Unapproved Dye

    Kutol Products Co Inc is recalling Hands Down Medicated Lotion Soap because it contains Red Dye #15, an ingredient not approved for use in drugs.

    Product
    Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1851-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2012·2012-06-27

    Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software

    Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.

    Product
    The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1383-2012·2012-06-27

    Linde Recalls 283 Oxygen Cylinders Due to Calibration Deviations

    Linde Gas LLC is recalling 283 oxygen cylinders in Ohio because expired calibration equipment may have caused incorrect filling levels.

    Product
    LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1812-2012·2012-06-27

    Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.

    Product
    PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1824-2012·2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood s
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1820-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems, Inc. is voluntarily recalling 91 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA regist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1454-2012·2012-06-27

    Camerican International Recalls Smoked Oysters Due to Norovirus Contamination

    Camerican International is recalling smoked oysters in cottonseed oil due to insanitary conditions and norovirus contamination risks.

    Product
    Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2012·2012-06-27

    Physicians Total Care Recalls Lipitor Tablets Due to Chemical Contamination

    Physicians Total Care is recalling specific lots of Lipitor (atorvastatin calcium) 40 mg tablets due to chemical contamination identified as 2,4,6 tribromoanisole.

    Product
    Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1854-2012·2012-06-27

    Accumetrics Recalls VerifyNow System for P2Y12 Test Result Changes

    Accumetrics is recalling 1,167 VerifyNow Systems to correct the P2Y12 test results by removing the BASE and % Inhibition values.

    Product
    VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1819-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems is voluntarily recalling 3,665 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2012·2012-06-27

    Ultradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes

    Ultradent is recalling specific Peak SE Primer Kits because a syringe was mislabeled as Peak LC Bond Resin, posing a risk to dental bonding procedures.

    Product
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with bl
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1450-2012·2012-06-27

    Reese Colossal Smoked Oysters Recalled Due to Sanitation Concerns

    World Finer Foods, Inc. is recalling Reese Colossal Smoked Oysters due to inadequate sanitation controls that may have exposed the product to human fecal waste and norovirus.

    Product
    Reese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1813-2012·2012-06-27

    Tripath PrepStain Installation Kit Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.

    Product
    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1829-2012·2012-06-27

    Philips MultiDiagnost Eleva X-Ray System Cable Damage Recall

    Philips Healthcare is recalling 433 MultiDiagnost Eleva X-ray systems worldwide due to potential damage to system cables from repeated movement.

    Product
    Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. Gen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2012·2012-06-27

    Accumetrics Recalls VerifyNow P2Y12 Assay for Field Correction

    Accumetrics is recalling the VerifyNow P2Y12 Assay to implement a field correction that eliminates the reporting of BASE and % Inhibition results.

    Product
    VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1521-2012·2012-06-27

    Kerry Foods Recalls Lactic Acid Products Due to Metal Fragment Contamination

    Kerry Foods is voluntarily recalling lactic acid products contaminated with metal fragments. The affected items were distributed in 15 US states, Canada, and Chile.

    Product
    KERRY, KF # 11605R, CONTAINS MILK, Item #B18648.02 , Net Wt 50 Lb (22.68Kg)
    Category
    Food
    Distribution
    15 states
  • LowFDA (Devices)·Z-1814-2012·2012-06-27

    Tripath Imaging Recalls 480 Test Kits Due to Leaking Pipettes

    Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.

    Product
    Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1825-2012·2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling specific lots of Heparin Lock Flush Solution because of incomplete documentation associated with test results.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 5 mL Multiple Dose Vial, 500 USP Units/5 mL, plastic vial, vial size 6 mL, ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1815-2012·2012-06-27

    Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect

    Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.

    Product
    PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1390-2012·2012-06-27

    Hospira Recalls Magnesium Sulfate Injection Due to High Potency

    Hospira, Inc. is recalling 164,568 containers of Magnesium Sulfate in Water for Injection because the product contained higher levels of magnesium sulfate than specified.

    Product
    MAGNESIUM SULFATE IN WATER — MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1460-2012·2012-06-27

    FDA Removes Korean Shellfish Shippers from Interstate List

    The FDA removed all Korean certified shippers of molluscan shellfish from the Interstate Shellfish Shippers List because the Korean Shellfish Sanitation Program no longer meets required sanitation controls.

    Product
    Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049.
    Category
    Food
    Distribution
    3 states
  • SevereCPSC·12739·2012-06-26

    Servpro Recalls Notus Air Movers Due to Fire Hazard

    Servpro is recalling about 24,000 Notus air movers/blowers because an internal electrical capacitor can fail and overheat, posing a fire hazard.

    Product
    Notus air movers/blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V295000·2012-06-26

    Prevost Recalls 2009-2012 Volvo 9700 Motor Coaches Due to Software Error

    Prevost is recalling 2009-2012 Volvo 9700 motor coaches because a software error may cause the vehicle to stop suddenly if the wheelchair lift door is not fully closed.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V304000·2012-06-26

    Prevost Recalls Two 2010 Coaches Due to Wheel Separation Risk

    Prevost is recalling two 2010 coaches because loose tag axle hub cap screws may cause wheel separation, increasing crash risk.

    Product
    PREVOST — PREVOST MTH XLII-45E, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V322000·2012-06-26

    Campagna V13R Recalled for Improperly Installed Seat Belt Buckle Hardware

    Campagna is recalling 2011-2012 V13R three-wheel vehicles because the seat belt buckle assembly may have been installed with reversed hardware, potentially compromising occupant restraint.

    Product
    CAMPAGNA — CAMPAGNA V13R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V303000·2012-06-26

    Prevost Recalls Coaches Due to Accelerator Pedal Sensor Defect

    Prevost is recalling certain H3-45 and X3-45 coaches because the accelerator pedal sensor may fail, causing the vehicle to stop responding to input and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide

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