The Recall Desk

Archive

March 2017 recalls

854 recalls were announced in March 2017.

What the numbers show

Critical
90
Severe
216
High
382
Moderate
134
Low
32

Of the 854 recalls this month scored against our rubric, 11% are Critical, 25% are Severe.

101–200 of 854

  • HighFDA (Food)·F-1716-2017·2017-03-29

    Chapis Spice & Tea Recalls Seasoned Bread Crumbs for Undeclared Allergens

    Chapis Spice & Tea is recalling Pan Molido Sazonado Seasoned Bread Crumbs due to undeclared allergens including wheat, milk, eggs, tree nuts, and soybean.

    Product
    Pan Molido Sazonado Seasoned Bread Crumbs, Net Wt. 6oz and 12oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1717-2017·2017-03-29

    Chapis Spice & Tea Recalls Bread Crumbs for Undeclared Allergens

    Chapis Spice & Tea is recalling Pan Molido Natural Bread Crumbs due to undeclared allergens including wheat, milk, eggs, tree nuts, and soybean.

    Product
    Pan Molido Natural Bread Crumbs, Net Wt. 6oz and 12oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1496-2017·2017-03-29

    Merge Cardio software recall due to patient data display error

    Merge Healthcare is recalling Merge Cardio software versions with IPID because the system may display images from different patients as if they belong to the same individual.

    Product
    Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-1627-2017·2017-03-29

    Diamond Crystal Cocoa Powder Recalled for Potential Metal Contamination

    Diamond Crystal Brands is recalling Chef's Companion Natural Cocoa Powder because metal pieces were found missing from a sifter screen during sanitation.

    Product
    Natural Cocoa Powder 22-24% cocoa butter, Net Wt. 5 lbs. (2.27 kg) packaged under the following brand name: Chef's Companion: 1 bag /case, UPC 10719098582240; Diamond Crystal Brands, Inc. Savannah, GA 31405
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1690-2017·2017-03-29

    Lakeside Foods Recalls Frozen Peas and Carrots for Listeria Risk

    Lakeside Foods is voluntarily recalling specific frozen peas and carrots products due to potential Listeria monocytogenes contamination.

    Product
    Kroger Peas & Carrots, Net Wt. 12 oz (340g), UPC 11110-89741; Harris Teeter Peas and Diced Carrots 12 oz, UPC 007203671661
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1667-2017·2017-03-29

    Carriage House Creations Recalls Hot Barbecue Sauce for Undeclared Allergens

    Carriage House Creations is recalling Hot Barbecue Sauce due to undeclared peanuts and soy. The recall was triggered by a notification regarding a Worcestershire sauce ingredient.

    Product
    Hot Barbecue Sauce; Net wt. 16 ounces; Manufactured by Carriage House Creations, 544 Gordon Alley, Reynoldsville, PA 15851;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1628-2017·2017-03-29

    Dito's Strawberry Platters Recalled for Undeclared Milk and Soy

    Dito's is recalling refrigerated strawberry platters with chocolate frosting due to undeclared milk and soy allergens.

    Product
    Ditos Heart shaped plastic Platter of Strawberries with Dip of Chocolate Frosting- Refrigerated. Net wt. 32 oz. UPC 8 93268 00142 7. The label is read in parts: "***Heart Platter Strawberries w/ Dip***32 oz.*** Strawberries USA (dip)***by Dito's LLC, Anchorage, AK 99518***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1675-2017·2017-03-29

    Whole Foods Spinach Orzo Salad Recalled for Undeclared Pine Nuts

    Whole Foods Market is recalling Spinach Orzo Salad sold in New England because it contains undeclared pine nuts, a potential allergen.

    Product
    Whole Foods Spinach Orzo Salad Our Chef's OWN, sold by weight PLU:beginning with 61159
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1242-2017·2017-03-29

    Route 11 Sour Cream & Chive Potato Chips Recalled for Salmonella Risk

    Small Fry Inc. is recalling Route 11 Sour Cream & Chive Potato Chips because an ingredient, nonfat dry milk powder, was found to contain Salmonella.

    Product
    Route 11 Sour Cream & Chive Potato Chips2 oz bag (30/cs) Route 11 Sour Cream & Chive Potato Chips6 oz bag (12/cs)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1516-2017·2017-03-29

    Medtronic Recalls Poly Component Trials Due to Cracked or Broken Dovetails

    Medtronic is recalling 111 units of Poly Component Trials because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, RE
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1543-2017·2017-03-29

    Medtronic Recalls Endurant Bifurcated Stent Grafts Due to Fabric Permeability

    Medtronic is voluntarily recalling specific Endurant and Endurant II bifurcated stent graft systems because fabric permeability variations may be associated with endoleaks during initial implant procedures.

    Product
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology:
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1520-2017·2017-03-29

    CareFusion Alaris System PC Unit Recall for Battery Alarm Failure

    CareFusion is recalling Alaris System PC units because low battery alarms may fail to trigger before the battery discharges, stopping all infusion channels.

    Product
    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2017·2017-03-29

    Merge Eye Station Import Utility Recalled for System Lockup Risk

    Merge Healthcare is recalling the Eye Station Import Utility software because system lockups may cause patient injury or delay diagnosis.

    Product
    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1499-2017·2017-03-29

    Stanley Security Recalls 500 Arial Wireless Call Pendants

    Stanley Security Solutions is recalling 500 Arial Wireless Water-Resistant Call Pendants because they were incorrectly programmed, which may prevent alarms from sounding when the button is pressed.

    Product
    Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1641-2017·2017-03-29

    Manzana Recalls Trader Joe's Apple Sauce Due to Glass Fragments

    Manzana Products Co. is recalling Trader Joe's All Natural Unsweetened Apple Sauce after finding small pieces of glass in the product.

    Product
    Trader Joe's All Natural Unsweetened Apple Sauce; 24 oz. glass jar. Best Before date stamped on top of lid. UPC: 00014359 Distributed by Trader Joe's, Monrovia, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1670-2017·2017-03-29

    Carriage House Creations Recalls Bourbon Basting Sauce for Undeclared Allergens

    Carriage House Creations is recalling specific varieties of Bourbon Basting Sauce and Hot BBQ Sauce due to undeclared peanuts and soy.

    Product
    Carriage House Creations; Bourbon Basting Sauce Hot; Net wt. 12 Ounces; Carriage House Creations, 544 Gordon Alley; Reynoldsville, PA 15851;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1714-2017·2017-03-29

    Country Fresh Marketside Stuffed Baby Bellas Recalled for Listeria Risk

    Country Fresh Inc. is recalling Marketside Garlic & Four Cheese Stuffed Baby Bellas due to possible Listeria monocytogenes contamination.

    Product
    Marketside Garlic & Four Cheese Stuffed Baby Bellas Net Wt. 7 oz. (198g) Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC: 681131148214
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1642-2017·2017-03-29

    Manzana Recalls Trader Joe's Apple Sauce Due to Glass Fragments

    Manzana Products Co. is recalling Trader Joe's Organic Unsweetened Apple Sauce after customer complaints and inspections revealed small pieces of glass in the product.

    Product
    Trader Joe's Organic Unsweetened Apple Sauce; 24 oz. glass jar. Best Before date stamped on top of lid. UPC: 00194877 Distributed by Trader Joe's, Monrovia, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1539-2017·2017-03-29

    Integra Recalls Panta Nails Due to Potential Sterility Seal Issues

    Integra LifeSciences is voluntarily recalling Panta and Panta XI Nails because package seals may not maintain intended sterility.

    Product
    Panta Nail, Rx only, Sterile,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1711-2017·2017-03-29

    Country Fresh Tuscan Style Portabella Mushrooms Recalled for Listeria Risk

    Country Fresh Inc. is recalling Tuscan Style Portabella Mushrooms due to possible contamination with Listeria monocytogenes. The product was distributed across ten southeastern and southern states.

    Product
    Country Fresh Creations Tuscan Style Portabella Mushrooms Net Wt. 8oz (227g) Distributed by Country Fresh, LLC., Houston, TX 77090 UPC: 074641072115
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1669-2017·2017-03-29

    Carriage House Creations Recalls Bourbon Basting Sauce for Undeclared Allergens

    Carriage House Creations is recalling specific varieties of Bourbon Basting Sauce and Hot BBQ Sauce due to undeclared peanuts and soy.

    Product
    Carriage House Creations; Bold N' Spicy Bourbon Basting Sauce; Net wt. 12 Ounces; Carriage House Creations, 544 Gordon Alley; Reynoldsville, PA 15851;
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1626-2017·2017-03-29

    Diamond Crystal Cocoa Powder Recalled for Potential Metal Contamination

    Diamond Crystal Brands is recalling specific lots of Natural Cocoa Powder because metal pieces were found missing from a sifter screen during sanitation.

    Product
    Natural Cocoa Powder 10-12% cocoa butter, Net Wt. 5 lbs. (2.27 kg) packaged under the following brand names: Monarch distributed by U.S. Foodservice UPC 50758108102533; Chef's Companion: 1 bag /case, UPC 10719098582233; and 6 bags/case, UPC 50719098582293 Diamond Crystal Brand
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1712-2017·2017-03-29

    Country Fresh Stuffed Mushrooms Recalled for Possible Listeria Contamination

    Country Fresh Inc. is recalling Stuffed Mushrooms due to possible Listeria monocytogenes contamination. The product was distributed in ten southeastern and southern states.

    Product
    Country Fresh Creations Stuffed Mushrooms Net Wt. 7 oz. (198g) Packed Regionally by Country Fresh LLC Headquarters, Conroe, TX 77384 www.countryfreshinc.com UPC: 074641072078
    Category
    Food
    Distribution
    10 states
  • HighCPSC·17120·2017-03-29

    Juratoys Recalls Janod Push Toy Trolleys Due to Impact Injury Hazard

    Juratoys is recalling four models of Bricolo by Janod push toy trolleys because they can tip backwards, posing an impact injury hazard to children.

    Product
    Bricolo by Janod ® Push toy trolleys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2017·2017-03-29

    Medtronic Poly Component Trial Knee Implants Recalled for Cracked Dovetails

    Medtronic Sofamor Danek USA Inc is recalling 72 units of Poly Component Trial knee implants because the dovetails were observed as cracked or broken.

    Product
    Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial -
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·17V217000·2017-03-29

    2016 Thomas Built Buses Saf-T-Liner C2 Recalled for Transmission Defect

    Daimler Trucks North America is recalling one 2016 Thomas Built Buses Saf-T-Liner C2 school bus because the transmission grade brake may fail to deactivate, increasing crash risk in slippery conditions.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1494-2017·2017-03-29

    Nidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming

    Nidek Inc is recalling Final Fit Software versions 1.11 and 1.12 for the EC-5000 Excimer Laser System because treatment planning could be programmed with an unintended correction.

    Product
    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1517-2017·2017-03-29

    Merge Healthcare Recalls Merge Cardio Software Due to Data Integrity Issues

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 9.0.8 because users can merge device files with confirmed reports, potentially adding unverified information.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1629-2017·2017-03-29

    Dito's Mixed Fruit Platters Recalled for Undeclared Milk and Soy

    Dito's is recalling 40-ounce mixed fruit platters with chocolate frosting due to undeclared milk and soy allergens. The product was distributed in Alaska.

    Product
    Ditos Heart shaped plastic platter of mixed fruits with Dip of Chocolate Frosting- Refrigerated. Net wt. 40 oz. UPC 8 93268 00198 4. The label is read in parts: "***Heart Platter Mixed Fruit w/ Dip***40 oz.*** Cantaloupe (US), Honeneydew (Mexico), Pineapple (Costa Rica)***by
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1525-2017·2017-03-29

    BioMerieux Recalls ETEST Vancomycin Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Vancomycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2017·2017-03-29

    Hitachi Echelon MRI System Recalled for Image Data Transfer Errors

    Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2017·2017-03-29

    Siemens ADVIA Centaur XPT Software Recall for Workflow Issues

    Siemens is recalling ADVIA Centaur XPT software versions V1.0.1 through V1.2 due to issues that may delay testing and affect system workflow.

    Product
    ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagent
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1532-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftriaxone strips because their shelf-life claims are not supported by internal testing. The products were distributed worldwide.

    Product
    ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1526-2017·2017-03-29

    BioMerieux Recalls ETEST Doripenem Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Doripenem DOR32 FOAM packaging strips because internal testing does not support the current shelf-life claims.

    Product
    ETEST Doripenem DOR32 FOAM packaging, Product Name: Etest Doripenem DOR 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2017·2017-03-29

    Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files

    Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.

    Product
    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1523-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftriaxone Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftriaxone antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST¿ Ceftriaxone TXL32 SPB, Product Name: ETEST¿ Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Ent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1638-2017·2017-03-29

    Jugos La Morovena Lemon Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling lemon juice in Puerto Rico because the labels lack the required warning for people with phenylketonuria.

    Product
    Jugos La Morove¿a, Lim¿n (Lemon) ,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1491-2017·2017-03-29

    Siemens Recalls 80 ONCOR MRI Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ONCOR MRI systems nationwide to install a software update.

    Product
    ONCOR" Expression ONCOR" Impression ONCOR" Impression plus
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1540-2017·2017-03-29

    Hitachi Oasis MRI System Recalled for Image Data Transfer Errors

    Hitachi Medical Systems America Inc is recalling 210 Hitachi Oasis MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Oasis MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1486-2017·2017-03-29

    Merge Healthcare Recalls Cardio Software Due to STAT Study Display Issue

    Merge Healthcare is recalling Merge Cardio software versions 9.0 through 10.1.2 because the study list fails to display STAT studies without a manual refresh.

    Product
    Merge Cardio software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2017·2017-03-29

    BioMerieux Recalls ETEST Cephalothin CE 256 Foam Packaging Due to Stability Issues

    BioMerieux SA is recalling ETEST Cephalothin CE 256 Foam packaging because current shelf-life claims are not supported by internal testing.

    Product
    ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1527-2017·2017-03-29

    BioMerieux Recalls Etest Benzyl Penicillin Strips Due to Stability Issues

    BioMerieux SA is recalling Etest Benzyl Penicillin PG256 FOAM packaging because shelf-life claims are not supported by internal testing.

    Product
    ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2017·2017-03-29

    MedComp Recalls 9.6F CT Ports with Incorrect Introducer Size

    Medical Components, Inc. is recalling 71 units of 9.6F CT Ports because they were packaged with 9F introducers instead of the labeled 10F size, preventing proper insertion.

    Product
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids,
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1518-2017·2017-03-29

    Raindrop Near Vision Inlay Recall for Updated Instructions for Use

    ReVision Optics is recalling 1,279 Raindrop Near Vision Inlays to update instructions for use regarding irrigation and medication timing.

    Product
    Raindrop Near Vision Inlay, Model# RD1-1
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-1492-2017·2017-03-29

    Philips CT Scanner Recall for Incorrect 4D CT Image Phase Annotations

    Philips is recalling 11 Brilliance BigBore Oncology CT scanners because retrospective 4D CT scans may display incorrect phase annotations.

    Product
    Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equi
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1487-2017·2017-03-29

    Crossroads MotoCLIP Super Elastic Fusion System Recalled for Incorrect Sizing

    Crossroads Extremity Systems is recalling 20 units of MotoCLIP Super Elastic Fusion Systems because seven implants were incorrectly sized and labeled.

    Product
    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1530-2017·2017-03-29

    BioMerieux Recalls ETEST Gentamicin Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Gentamicin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2017·2017-03-29

    Tearscience LipiFlow System Recalled for Inconsistent Storage Temperature Labeling

    Tearscience is recalling LipiFlow Thermal Pulsation Systems because the labeled storage temperature does not match tested conditions for the full shelf life.

    Product
    LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0604-2017·2017-03-29

    Bayer Recalls A+D Diaper Rash Cream Due to Labeling Error

    Bayer HealthCare Pharmaceuticals is recalling A+D Diaper Rash Cream due to a labeling claim issue regarding undeclared excipients.

    Product
    A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0612-2017·2017-03-29

    Fougera Recalls Desonide Ointment Tubes Due to Labeling Mixup

    Fougera Pharmaceuticals is recalling 14,665 tubes of Desonide Ointment because unit boxes may contain tubes labeled as Ketoconazole Cream.

    Product
    Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2017·2017-03-29

    BioMerieux Recalls ETEST Fosfomycin Strips Due to Unsupported Shelf-Life Claims

    BioMerieux SA is recalling ETEST Fosfomycin FM1024 strips because internal testing does not support the current shelf-life claims.

    Product
    ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1531-2017·2017-03-29

    BioMerieux Recalls ETEST Tobramycin Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Tobramycin antimicrobial susceptibility testing strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0610-2017·2017-03-29

    AvKARE Recalls Famciclovir Tablets Due to Impurity Levels

    AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.

    Product
    Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1500-2017·2017-03-29

    Haag-Streit EyeSuite Software Recalled for Potential Patient Data Misattribution

    Haag-Streit USA Inc is recalling EyeSuite i.8.2.1.0 software due to a risk that patient data may be stored under the wrong patient on the DICOM Server.

    Product
    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1493-2017·2017-03-29

    Philips Recalls Brilliance BigBore CT Scanners Due to Image Reconstruction Error

    Philips is recalling 67 Brilliance BigBore CT scanners because 4D CT images may be reconstructed at a single phase while incorrectly labeled as specific phases.

    Product
    Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equ
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-1484-2017·2017-03-29

    FDA Recalls Microbore Extension Sets Due to Incorrect Priming Volume Labeling

    Vygon MFG is recalling 30,700 AMS-636 Microbore extension sets because the package displays an incorrect priming volume.

    Product
    AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1488-2017·2017-03-29

    Siemens Recalls 80 ARTISTE MV Systems for Software Update

    Siemens Medical Solutions is voluntarily recalling 80 ARTISTE MV Systems to install a software update. The devices were distributed throughout the United States.

    Product
    ARTISTE" MV System
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1415-2017·2017-03-29

    Merge Cardio Software Recall Due to Missing Read-Only Notification

    Merge Healthcare is recalling Merge Cardio software versions 9.0.9 and earlier because a defect allows two physicians to access the same study report without a read-only prompt.

    Product
    Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1533-2017·2017-03-29

    Siemens Syngo.plaza PACS Systems Recalled for Software Update Issues

    Siemens Medical Solutions is recalling 13 Syngo.plaza PACS systems nationwide due to software update issues. The recall is voluntary and has been terminated.

    Product
    Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2017·2017-03-29

    Hitachi Echelon Oval MRI System Recalled for Image Data Errors

    Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval MRI Systems because image data transferred to workstations showed errors on the slice position reference image.

    Product
    Hitachi Echelon Oval MRI System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2017·2017-03-29

    Teleflex Recalls Non-Latex Nasopharyngeal Airways Due to Labeling Error

    Teleflex Medical is recalling 7,600 units of Green Non-Latex Robertazzi Nasopharyngeal Airways due to a labeling error. The voluntary recall covers products distributed in the US, Canada, and Mexico.

    Product
    Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2017·2017-03-29

    BioMerieux Recalls ETEST Ciprofloxacin CI 32 Foam Due to Stability Issues

    BioMerieux SA is recalling ETEST Ciprofloxacin CI 32 Foam products because their shelf-life claims are not supported by internal testing.

    Product
    Ciprofloxacin CI 32 Foam packaging, Product Name: ETEST Ciprofloxacin CI 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2017·2017-03-29

    BioMerieux Recalls ETEST Ceftazidime Strips Due to Stability Issues

    BioMerieux SA is recalling ETEST Ceftazidime TZ256 strips because their shelf-life claims are not supported by internal testing.

    Product
    ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2017·2017-03-29

    BioMerieux Recalls ETEST Imipenem IP32 Foam Packaging Due to Stability Issues

    BioMerieux SA is recalling ETEST Imipenem IP32 Foam packaging because the current shelf-life claims are not supported by internal testing.

    Product
    ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Entero
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1512-2017·2017-03-29

    Devicor Mammotome Revolve Biopsy System Recalled for Missing Labeling

    Devicor Medical Products Inc is recalling 320 Mammotome Revolve Dual Vacuum Assist Biopsy Systems because they lack required probe labeling, product codes, and sterilization stickers.

    Product
    Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Food)·F-1632-2017·2017-03-29

    Jugos La Morovena Grapefruit Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 195 gallons of grapefruit juice in Puerto Rico because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Toronja (Grapefruit),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1635-2017·2017-03-29

    Jugos La Morovena Soursop Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 95 gallons of Soursop juice in Puerto Rico because the labels lack the required phenylalanine warning for people with phenylketonuria.

    Product
    Jugos La Morove¿a, Guanabana (Soursop),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1636-2017·2017-03-29

    Jugos La Morovena Passion Fruit Juice Recalled for Missing Label Warning

    Jugos y Agua La Morovena Inc. is recalling 150 gallons of Passion Fruit Juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Parcha (Passion Fruit),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0608-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension due to failed dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1634-2017·2017-03-29

    Jugos La Morovena Fruit Punch Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling 100 gallons of Fruit Punch juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Fruit Punch,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0609-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling specific lots of Quillivant XR extended-release oral suspension because the product failed to meet dissolution specifications at 12 months.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0607-2017·2017-03-29

    Pfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failure

    Pfizer is recalling Quillivant XR extended-release oral suspension because it failed to meet dissolution specifications at 12 months. The recall affects 28,938 units distributed nationwide.

    Product
    Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1637-2017·2017-03-29

    Jugos La Morovena Acerola Cherry Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling Acerola Cherry Juice because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Acerola (Cherry), Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1633-2017·2017-03-29

    Jugos La Morovena Grape Juice Recalled for Missing Phenylketonuria Warning

    Jugos y Agua La Morovena Inc. is recalling 106 gallons of grape juice in Puerto Rico because the labels lack the required phenylketonuria warning.

    Product
    Jugos La Morove¿a, Uva (Grape),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1631-2017·2017-03-29

    Jugos La Morovena Orange Juice Recalled for Missing Phenylketonuria Warning

    Jugos y Agua La Morovena Inc. is recalling 309 gallons of orange juice in Puerto Rico because the labels lack the required phenylalanine warning for people with phenylketonuria.

    Product
    Jugos La Morove¿a, China (Orange),Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1639-2017·2017-03-29

    Jugos La Morovena Tamarind Juice Recalled for Missing Phenylalanine Warning

    Jugos y Agua La Morovena Inc. is recalling Tamarind Juice in Puerto Rico because the labels lack the required phenylalanine warning for individuals with phenylketonuria.

    Product
    Jugos La Morove¿a, Tamarindo (Tamarind) ,Elaborado y Envasado por Jugos La Morove¿a, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V214000·2017-03-28

    Schwarze Street Sweepers Recalled for Air Brake Line Fitting Defect

    Schwarze is recalling 2013-2017 street sweepers because incorrect air brake fittings may cause air leaks and unexpected vehicle stops.

    Product
    SCHWARZE — SCHWARZE A8 TWISTER STREET SWEEPER, M6 AVALANCHE STREET SWEEP, A7 TORNADO STREET SWEEPER, A9 MONSOON STREET SWEEPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17736·2017-03-28

    SolarWorld Recalls Solar Panel Connectors Due to Electrical Shock Hazard

    SolarWorld is recalling about 97,000 solar panel connectors sold in the U.S. because microscopic cracks can allow moisture to leak in, posing an electrical shock hazard.

    Product
    Connectors sold with solar panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17117·2017-03-28

    Look Cycle Recalls Road Bikes and Aerostems Due to Fall Hazards

    Look Cycle is recalling about 800 road bikes and Aerostems because a stainless steel clamp can corrode and break, posing a fall and crash hazard.

    Product
    Look Cycle road bikes and Aerostems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V209000·2017-03-27

    Ford Recalls 2013-2015 Models Due to Engine Overheating Fire Risk

    Ford is recalling 2013-2015 Escape, Fiesta, Fusion, and Transit Connect vehicles with 1.6L engines because low coolant can cause the engine head to crack, leak oil, and start a fire.

    Product
    FORD — FORD FUSION, ESCAPE, FIESTA, TRANSIT CONNECT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V212000·2017-03-27

    Ford Recalls 2017 F-450 and F-550 Superduty Trucks for Driveline Fracture Risk

    Ford is recalling 2017 F-450 and F-550 Superduty trucks because the driveline may vibrate and fracture at highway speeds, potentially causing loss of motive power and increasing crash risk.

    Product
    FORD — FORD F-450 SD, F-550 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V211000·2017-03-27

    Great Dane Recalls 2018 Everest SS Trailers Due to Brake Plug Issue

    Great Dane is recalling 2018 Everest SS refrigerated trailers because a front brake chamber plug may be loose, potentially reducing brake pressure and increasing stopping distance.

    Product
    GREAT DANE — GREAT DANE EVEREST SS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V205000·2017-03-27

    Ford Recalls 2017 Edge Vehicles for Windshield Welding Defect

    Ford is recalling 2017 Edge vehicles with Panoramic Vista Roofs due to an improperly welded windshield header that reduces lateral structural integrity.

    Product
    FORD — FORD EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V210000·2017-03-27

    Ford Recalls 2013-2014 Vehicles Due to Door Latch Defect

    Ford is recalling 2013-2014 Lincoln MKZ, Ford Fusion, and 2014 Ford Fiesta vehicles because door latches may break, leaving doors unsecured.

    Product
    LINCOLN — LINCOLN, FORD MKZ, FUSION, FIESTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V206000·2017-03-27

    Keystone Recalls 2017 Cougar Trailers Due to Fire Risk

    Keystone is recalling 2017 Cougar recreational trailers because a manual-resetting circuit breaker near propane storage may spark and cause a fire.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·031-2017·2017-03-24

    Ajinomoto Recalls Frozen Beef Taquitos Due to Foreign Matter Contamination

    Ajinomoto Windsor is recalling frozen beef taquitos that may contain rubber and plastic pieces. No illnesses have been reported.

    Product
    Ajinomoto Windsor Inc. — Ajinomoto Windsor, Inc. Recalls Frozen Ready-To-Eat Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    9 states
  • ModerateUSDA FSIS·032-2017·2017-03-24

    Lakes Farm Raised Catfish Recalls Frozen Products Due to Chemical Residues

    Lakes Farm Raised Catfish Inc. is recalling approximately 1,695 pounds of frozen catfish products found to contain residues of Malachite Green and Leucomalachite Green.

    Product
    Lakes Farm Raised Catfish Inc — Lakes Farm Raised Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration
    Category
    Food
    Distribution
    2 states

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