The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

701–800 of 1183

  • HighFDA (Devices)·Z-1936-2015·2015-07-08

    Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 130 cases distributed nationwide and in Canada and Germany.

    Product
    Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 540 Angiographic X-ray Systems

    GE Healthcare is recalling six Innova IGS 540 angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 540. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2015·2015-07-08

    GE Healthcare Recalls Innova 3131IQ Angiographic X-ray Systems

    GE Healthcare is recalling two Innova 3131IQ angiographic X-ray systems due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2015·2015-07-08

    Medtronic Recalls DLP Femoral Arterial Cannulas Due to Connection Issues

    Medtronic is recalling specific lots of DLP Femoral Arterial Cannulas because users reported difficulty connecting the device to perfusion circuit tubing.

    Product
    Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter tran
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z1855-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2015·2015-07-08

    GE Healthcare Recalls Discovery IGS 730 Systems Due to Gantry Motion Loss

    GE Healthcare is recalling four Discovery IGS 730 angiographic X-ray systems worldwide due to a potential safety issue that may result in the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1903-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units distributed in the US and internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2015·2015-07-08

    Covidien Recalls Chronic Catheters That May Not Meet Antimicrobial Specifications

    Covidien LLC is recalling specific lots of Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2015·2015-07-08

    GE Healthcare Recalls Innova 2100IQ Angiographic X-ray Systems

    GE Healthcare is recalling 13 Innova 2100IQ angiographic X-ray systems due to a potential safety issue that may cause the loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2785-2015·2015-07-08

    Sunridge Coconut Chews Recalled for Stainless Steel Wire Fragments

    Falcon Trading Co. is recalling Sunridge Coconut Chews due to the presence of stainless steel wire fragments in the shredded coconut.

    Product
    Sunridge Candy-Coconut Chews, Vanilla. 10 lb. box. Item code: 023617; UPC: 086700936177 Falcon Trading Company Inc/Sun Ridge Farms, Royal Oaks, CA
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1500-2015·2015-07-08

    Snoqualmie Champagne Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Champagne Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Champagne Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1496-2015·2015-07-08

    Snoqualmie Blackberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Blackberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Blackberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1566-2015·2015-07-08

    Snoqualmie Pistachio Gelato Recalled for Listeria Contamination Risk

    Snoqualmie Gourmet Ice Cream is recalling Pistachio Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide in various container sizes.

    Product
    Pistachio Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1 gallon plastic trays; 1.5 and 3 gallon plastic tubs and other unknown container type/sizes. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2015·2015-07-08

    Siemens Rapidlab 1260 Blood Gas Analyzer Recalled for Diagnostic Error Codes

    Siemens Healthcare Diagnostics is recalling 122 Rapidlab 1260 blood gas analyzers because specific diagnostic error codes are not functional.

    Product
    The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1511-2015·2015-07-08

    Snoqualmie Guava Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Guava Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Guava Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1461-2015·2015-07-08

    Snoqualmie 19% Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 19% Ice Cream Mix due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 2.5 gallon bags.

    Product
    19% Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1560-2015·2015-07-08

    Snoqualmie Hazelnut Gelato Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Hazelnut Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Hazelnut Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 gallon plastic tubs, in addition to other unknown size/containers. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1540-2015·2015-07-08

    Snoqualmie Pomegranate Cranberry Sorbet Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Pomegranate Cranberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Pomegranate Cranberry Sorbet, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2015·2015-07-08

    Snoqualmie Soft-Serve Ice Cream Mix Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling 5.5% Soft-Serve Ice Cream Mix due to potential Listeria monocytogenes contamination.

    Product
    5.5% Soft-Serve Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2015·2015-07-08

    JustRight 5mm Stapler Reloads Recalled for Incomplete Staple Formation

    Justright Surgical is recalling JustRight 5mm Stapler Reloads because they may deliver incomplete staple formation and incomplete tissue closure.

    Product
    JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits

    FDA Class II recall of Palindrome Precision SI Chronic Catheter Kits due to potential failure to meet antimicrobial specifications.

    Product
    Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1973-2015·2015-07-08

    GE Healthcare Recalls Optima IGS 320 Angiographic X-ray Systems

    GE Healthcare is recalling three Optima IGS 320 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2015·2015-07-08

    FDA Recalls Palindrome Precision Chronic Catheters for Antimicrobial Specification Failure

    The FDA is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1472-2015·2015-07-08

    Snoqualmie Cookie Dough Custard Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Cookie Dough Custard due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 3-gallon tubs.

    Product
    Cookie Dough Custard, sold under Snoqualmie brand. Product is sold in 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2015·2015-07-08

    Atrium Medical Recalls Ocean Water Seal Chest Drains Due to Missing O-Ring

    Atrium Medical Corporation is recalling Ocean Water Seal Chest Drains because they have a missing o-ring. The recall covers 390 cases distributed nationwide, in Canada, and in Germany.

    Product
    Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2015·2015-07-08

    FDA Recalls Palindrome Precision SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Defects

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2015·2015-07-08

    GE Healthcare Recalls Innova 2121IQ Angiographic X-ray Systems

    GE Healthcare is recalling Innova 2121IQ angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2015·2015-07-08

    Siemens Rapidlab 1265 Blood Gas Analyzer Recalled for Diagnostic Error Code Failure

    Siemens Healthcare Diagnostics is recalling 2,713 Rapidlab 1265 blood gas analyzers because specific diagnostic error codes are not functional.

    Product
    The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1556-2015·2015-07-08

    Snoqualmie Creme Fraiche Gelato Recalled for Listeria Risk

    Snoqualmie Gourmet Ice Cream is recalling Creme Fraiche Gelato due to potential Listeria monocytogenes contamination. The product was distributed nationwide in 1.5 and 3 gallon tubs.

    Product
    Creme Fraiche (with soy lecithin) Gelato, sold under Snoqualmie Ice Cream brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2015·2015-07-08

    Palindrome Precision SI Chronic Catheter Kit Recalled for Antimicrobial Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1948-2015·2015-07-08

    Zimmer Recalls Natural Knee II Revision Femoral Stems Due to Sterility Breach

    Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.

    Product
    Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2015·2015-07-08

    GE Healthcare Recalls Innova IGS 530 Angiographic X-ray Systems

    GE Healthcare is recalling 17 Innova IGS 530 angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.

    Product
    GE Healthcare Innova IGS 530. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheters for Antimicrobial Defects

    The FDA is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2015·2015-07-08

    Abbott ICT Serum Calibrator Recalled for Inaccurate Potassium Results

    Abbott Laboratories is recalling ICT Serum Calibrator REF 146-03 because it may generate lower than expected Potassium results on the Abbott Architect cSystem.

    Product
    ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1507-2015·2015-07-08

    Snoqualmie Cranberry Sorbet Recalled for Potential Listeria Contamination

    Snoqualmie Gourmet Ice Cream is recalling Cranberry Sorbet due to potential Listeria monocytogenes contamination. The product was distributed nationwide.

    Product
    Cranberry Sorbet, sold under Snoqualmie brand. Product is sold in 1.5 and 3 gallon plastic tubs. No UPC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2015·2015-07-08

    Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units distributed worldwide.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1851-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2015·2015-07-08

    New Star Lasers Recalls StoneLight 30 Laser Systems Due to Energy Discrepancy

    New Star Lasers is recalling 52 StoneLight 30 Laser Systems because a software issue may cause the delivered energy to differ from the displayed value.

    Product
    StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, a
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1947-2015·2015-07-08

    BioMerieux Etest Cefotaxime CT 256 In Vitro Diagnostic Recall

    BioMerieux SA is recalling Etest Cefotaxime CT 256 in vitro diagnostic devices because quality control results were out of range, potentially causing false resistant strain results.

    Product
    Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2015·2015-07-08

    Siemens Recalls 37 Cios Alpha Mobile X-ray Systems for Freezing Defect

    Siemens is recalling 37 Cios Alpha mobile X-ray systems because they may freeze during procedures. The recall is classified as Class II.

    Product
    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2015·2015-07-08

    FDA Recalls Palindrome HSI Chronic Catheter Kits for Antimicrobial Spec Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z1856-2015·2015-07-08

    Palindrome SI Chronic Catheter Sport Pack Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome SI Chronic Catheter Sport Packs because they may not meet antimicrobial specifications.

    Product
    Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2015·2015-07-08

    FDA Recalls Palindrome SI Chronic Catheter Kits for Antimicrobial Specification Failure

    The FDA is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1906-2015·2015-07-08

    Palindrome HSI Chronic Catheter Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2015·2015-07-08

    RTI Surgical Recalls Mislabeled Bullet-Tip PEEK VBR Implants

    RTI Surgical is recalling 18 units of three lots of Bullet-Tip PEEK VBR implants distributed in Florida and New York due to incorrect color labeling.

    Product
    Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System,
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1941-2015·2015-07-08

    Boston Scientific Recalls Extractor Pro RX Retrieval Balloon Catheter Due to Labeling Error

    Boston Scientific is recalling one lot of Extractor Pro RX Retrieval Balloon Catheters because the device contains a syringe size larger than what is identified on the label.

    Product
    Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injectio
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1919-2015·2015-07-08

    LifeHealth IRMA TRUPoint 443914 Recalled for Barometric Pressure Drift

    LifeHealth is recalling seven IRMA TRUPoint 443914 devices because their barometric pressure measurements drift over time, potentially affecting critical care analyte results.

    Product
    LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1910-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1928-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling 6,255 units of the LDL-Cholesterol plus gen.2. test due to potential false results caused by drug interference.

    Product
    LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1890-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    The FDA is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2015·2015-07-08

    Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1869-2015·2015-07-08

    Covidien Recalls Palindrome Precision SI Chronic Catheter Kits

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1942-2015·2015-07-08

    Siemens EasyLink Data Management System Recalled for Software Limitations

    Siemens Healthcare Diagnostics is recalling 1,355 units of the EasyLink Data Management System due to software issues affecting reference ranges and sample actions.

    Product
    EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2015·2015-07-08

    Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite 200 in vitro diagnostic. Product Usage: The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2015·2015-07-08

    Roche Lactate Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Lactate reagent due to potential false results caused by drug interference with the Trinder reaction method.

    Product
    Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate concentration in plasm and cerebrospinal fluid.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1940-2015·2015-07-08

    Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

    Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

    Product
    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2015·2015-07-08

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite M1000 PRO microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1912-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1889-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2015·2015-07-08

    Roche HDL-Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol plus gen.3. reagents due to potential false results when used with certain drugs.

    Product
    HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2015·2015-07-08

    Palindrome SI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2015·2015-07-08

    DePuy Synthes Titanium Recon Screws Recalled for Incorrect Insert

    Synthes, Inc. is recalling 276 DePuy Synthes 6.5 mm Titanium Recon Screws because certain lots contain the wrong insert.

    Product
    DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending patholo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1959-2015·2015-07-08

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Data Loss

    Siemens Medical Solutions USA is recalling 573 ACUSON SC2000 ultrasound systems because specific keystrokes during 2D Stress Echo studies may cause selected clips to not be saved.

    Product
    ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1933-2015·2015-07-08

    Siemens SOMATOM Emotion 16 CT Scanners Recalled for Broken Gantry Screws

    Siemens is recalling 40 SOMATOM Emotion 16 CT scanners due to broken or bowed screws in the gantry balance weight assembly.

    Product
    SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1924-2015·2015-07-08

    Roche HDL-Cholesterol gen.3. Recalled for Potential Drug Interference

    Roche Diagnostics is recalling HDL-Cholesterol gen.3. reagents due to potential false results caused by drug interference on Cobas Analyzers.

    Product
    HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2015·2015-07-08

    Intuitive Surgical Recalls da Vinci Xi Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci Xi Instrument Arm Drapes because a pinched drape may cause a 'Missing reload error' on the Vision Cart touchscreen.

    Product
    INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1930-2015·2015-07-08

    Roche Diagnostics Recalls Triglycerides/Glycerol Blanked In Vitro Test Kits

    Roche Diagnostics is recalling 6,255 units of Triglycerides/Glycerol Blanked in vitro test kits due to possible drug interference that may cause falsely decreased results.

    Product
    Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of triglycerides in human serum and plasma or Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2015·2015-07-08

    Roche Cholesterol Gen.2 Cassette Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol Gen.2 cassettes because Trinder reaction tests may yield falsely decreased results when specific drugs are present.

    Product
    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2015·2015-07-08

    Roche Triglycerides GPO Test Recalled for Potential Drug Interference

    Roche is recalling Triglycerides GPO tests because certain drugs may cause falsely decreased results on specific Cobas analyzers.

    Product
    Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1907-2015·2015-07-08

    Palindrome HSI Chronic Catheter Recall for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D1151-2015·2015-07-08

    Qualitest Recalls Disulfiram Tablets Due to Dissolution Failure

    Qualitest Pharmaceuticals is recalling 2,016 bottles of Disulfiram tablets because one lot failed routine stability testing for dissolution specifications.

    Product
    Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2015·2015-07-08

    Roche LDL-Cholesterol Test Recalled for Potential Drug Interference

    Roche Diagnostics is recalling the LDL-Cholesterol gen.2 test because certain drugs may cause falsely decreased results when using the Trinder reaction method.

    Product
    LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density lipoprotein Cholesterol (LDL-C) in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1206-2015·2015-07-08

    Takeda Recalls Contrave Tablets Due to Broken or Split Defects

    Takeda Pharmaceuticals is recalling 3,619 bottles of Contrave extended-release tablets due to potential tablet defects, including broken tablets and equatorial splitting.

    Product
    CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1931-2015·2015-07-08

    Roche Uric Acid Plus Test Recalled for Drug Interference

    Roche Diagnostics is recalling Uric Acid plus ver.2 tests because results may be falsely decreased when used with certain drugs.

    Product
    Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULAR systems, cobas c111, COBAS Integra 800 and 400 plus systems, and cobas c systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2015·2015-07-08

    Siemens CentraLink Data Management System Software Recall

    Siemens recalls CentraLink software because the sample query function may fail to return all samples from Dimension Vista systems under specific configurations.

    Product
    CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2015·2015-07-08

    Axis-Shield Homocysteine Reagent Recalled for Performance Deterioration

    Axis-Shield Diagnostics is recalling Liquid Stable 2-Part Homocysteine Reagents due to performance deterioration that causes under-recovery of test results.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2015·2015-07-08

    Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug

    Tecan US, Inc. is recalling 868 Infinite F500 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.

    Product
    Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2015·2015-07-08

    Roche Cholesterol Reagent Recalled for Potential Drug Interference

    Roche Diagnostics is recalling Cholesterol CHOD-PAP reagents because drug interference may cause falsely decreased test results.

    Product
    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1960-2015·2015-07-08

    Spine Wave Access Kit Recalled for Mislabeled Probe Dimensions

    Spine Wave, Inc. is recalling 121 Spine Wave Access Kits because the outer carton mislabels the monopolar probe dimensions. The probe is listed as 200 x 1.5mm instead of the correct 280 x 1.5mm.

    Product
    Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythml
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1952-2015·2015-07-08

    Milestone Wand STA Handpiece Recalled Due to Mislabeled Packaging

    Milestone Scientific is recalling 165,850 Wand STA handpieces because they were mislabeled as STA handpieces, which cannot be installed in the STA instrument.

    Product
    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
    Category
    Medical Device
    Distribution
    4 states
  • SevereNHTSA·15V431000·2015-07-07

    Dodge Journey Recall: Engine Cover May Detach and Cause Fire

    Chrysler is recalling 2011-2015 Dodge Journey vehicles because the engine cover may detach and contact the exhaust manifold, increasing the risk of a vehicle fire.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·098-2015·2015-07-07

    Bassett and Walker Recalls Beef Lips Lacking Import Inspection

    Bassett & Walker International is recalling approximately 1,540 pounds of beef lip products produced in Australia that were not inspected at the U.S. point of entry.

    Product
    Bassett and Walker International, Inc. Recall Beef Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·15V432000·2015-07-07

    Thomas Built Buses Recall Emergency Door Handle Corrosion Defect

    Daimler Trucks North America is recalling 103,038 Thomas Built Buses because corrosion on the emergency door handle stem could delay evacuation during an emergency.

    Product
    THOMAS — THOMAS, THOMAS BUILT BUSES SAF-T-LINER CONVENTIONAL, SAF-T-LINER C2, SAF-T-LINER FS65, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V434000·2015-07-07

    Fleetwood Southwind Recalled for Missing Emergency Exit Window

    Allied Recreation Group is recalling 2015-2016 Fleetwood Southwind RVs because some may lack a required emergency exit window on the road side bedroom wall.

    Product
    FLEETWOOD — FLEETWOOD SOUTHWIND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V433000·2015-07-07

    Ferrari Recalls 2015 Models Due to Driver Air Bag Assembly Defect

    Ferrari is recalling 814 model year 2015 vehicles because an improperly assembled driver air bag module may deploy in a rotated orientation, increasing injury risk in a crash.

    Product
    FERRARI — FERRARI F12 BERLINETTA, LAFERRARI, 458, CALIFORNIA T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V428000·2015-07-06

    Prevost Recalls 2015 X3-45 Coaches Due to Front Hub Carrier Defect

    Prevost is recalling 68 model year 2015 X3-45 Commuter Coaches because front hub carriers may leak or crack, potentially causing loss of vehicle control.

    Product
    PREVOST — PREVOST X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V429000·2015-07-06

    Entegra Recalls 2015-2016 Cornerstone Motorhomes Due to Brake Hose Rubbing

    Entegra is recalling 2015-2016 Cornerstone motorhomes because rear jack plates may rub against the brake air hose, potentially reducing braking performance and increasing crash risk.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V427000·2015-07-06

    Harley-Davidson Recalls 2014-2015 Motorcycles Due to Saddlebag Mounting Defect

    Harley-Davidson is recalling approximately 185,272 model year 2014-2015 motorcycles because saddlebag mounting receptacles may not adequately secure the saddlebags, creating a road hazard.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLHXSE, FLHP, FLHR, FLHTCU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V426000·2015-07-06

    Mercedes-Benz Recalls 2014 CLA Models Due to Fuse Installation Error

    Mercedes-Benz is recalling 2014 CLA 250 and CLA 45 AMG vehicles because incorrectly installed fuses may cause airbag and instrument cluster failures.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLA250, AMG CLA45
    Category
    Vehicle
    Distribution
    Distributed nationwide

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