The Recall Desk

Archive

September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical
91
Severe
146
High
349
Moderate
125
Low
23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 20% are Severe.

601–700 of 734

  • LowFDA (Drugs)·D-1492-2016·2016-09-14

    Lupin Recalls Amlodipine Besylate Tablets Due to CGMP Deviations

    Lupin Limited is recalling Amlodipine Besylate tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-2719-2016·2016-09-14

    ReliaMed Silver Alginate Dressing Recalled for Missing Instructions

    Advanced Medical Solutions is recalling ReliaMed Silver Alginate dressings because some cartons are missing the required Instructions For Use leaflet.

    Product
    ReliaMed¿ Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1479-2016·2016-09-14

    Stason Recalls Selegiline HCl Tablets Due to Dissolution Failure

    Stason Pharmaceuticals is recalling Selegiline HCl tablets 5mg due to out-of-specification dissolution results for stability samples.

    Product
    Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2740-2016·2016-09-14

    Arrow Arterial Line Catheterization Kits Recalled for Shipping Labeling Error

    Arrow International Inc. is recalling 690 Arterial Line Catheterization Kits due to a shipping carton labeling error. The kits were distributed nationwide to five states.

    Product
    Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V658000·2016-09-13

    Freightliner Trucks Recalled for Brake Caliper Bolt Torque Issues

    Daimler Trucks North America is recalling 2016-2017 Freightliner M2 and 114 SD trucks because brake caliper mounting bolts may be incorrectly torqued, potentially reducing braking ability.

    Product
    FREIGHTLINER — FREIGHTLINER 114SD, BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E071000·2016-09-13

    EVS Emergency Vehicle Seats Recalled for Slide Track Defect

    EVS is recalling emergency vehicle seats with Dometic/Atwood slide tracks that may not engage properly, increasing injury risk in a crash.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V657000·2016-09-13

    Thomas Built Buses Saf-T-Liner C2 School Bus Fuel Leak Recall

    Daimler Trucks North America is recalling 114 model year 2017 Thomas Built Buses Saf-T-Liner C2 school buses due to a potential fuel leak risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V655000·2016-09-13

    Forest River Recalls 2017 Surveyor Trailers Due to Tire Placard Mismatch

    Forest River is recalling 2017 Surveyor recreational trailers because tires and rims may not match the Federal Placard, risking over-inflation and tire failure.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V654000·2016-09-12

    FCCC Motorhome Chassis Recall for Brake Signal Defect

    Daimler Trucks is recalling 2013-2016 FCCC XCM, XCR, and XCL motorhome chassis because a brake signal may remain active, causing towed device brakes to drag and potentially overheat.

    Product
    FCCC — FCCC XCM, XCL, XCR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·079-2016·2016-09-10

    MIH Marketing Recalls Meat and Poultry Products Due to Insanitary Conditions

    MIH Marketing and Sales is recalling approximately 662,049 pounds of raw chicken products stored under insanitary conditions, including rodent activity.

    Product
    MIH Marketing and Sales Recalls Meat and Poultry Products Due To Insanitary Conditions
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·080-2016·2016-09-10

    Savory Foods Recalls Pork Rinds Due to Undeclared Wheat Allergen

    Savory Foods is recalling approximately 32,928 pounds of Hot and Spicy Pork Rinds because the product contains wheat, a known allergen, which is not declared on the label.

    Product
    Savory Foods Recalls Pork Rinds Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·078-2016·2016-09-09

    PT Farm Recalls Lamb Products Due To Possible E. Coli Contamination

    PT Farm, LLC is recalling approximately 15 pounds of raw lamb products sold in Massachusetts due to possible E. coli contamination.

    Product
    Montshire Packing, LLC — PT Farm, LLC Recalls Lamb Products Due To Possible E. Coli Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V653000·2016-09-09

    BMW Recalls M2, M3, and M4 Models for Rear Sub-Frame Bolt Issue

    BMW is recalling specific M2, M3, and M4 vehicles because reused rear sub-frame bolts may loosen, affecting handling and increasing crash risk.

    Product
    BMW — BMW M2, M3, M4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·077-2016·2016-09-08

    Carnival Supermarket Recalls Ground Beef Due To E. Coli O157:H7

    Carnival Supermarket in Chula Vista, California, is recalling approximately 35 pounds of ground beef sold on Sept. 1, 2016, due to possible E. coli O157:H7 contamination.

    Product
    Paradise Valley Market, Inc. (Carnival Supermarket) Recalls Ground Beef Productsdue To Possible E. Coli O157:H7 Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V652000·2016-09-08

    Cambli Recalls 2014-2015 Beverage Industry Trailers Due to Brake Defect

    Cambli is recalling 2014-2015 Beverage Industry trailers because improperly machined spring brake valves may delay braking, causing the trailer to roll away.

    Product
    CAMBLI — CAMBLI BEVERAGE INDUSTRY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V648000·2016-09-08

    Audi Recalls 2017 Q7 Vehicles Due to Electric Power Steering Defect

    Volkswagen Group of America is recalling 2017 Audi Q7 vehicles because the electric power steering control unit may short circuit, causing a loss of steering assist and increasing crash risk.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16258·2016-09-08

    HAUS Mosquito Zapper LED Bulbs Recalled for Electrical Shock Hazard

    Creative Sourcing is recalling HAUS ZapBulb mosquito zapper LED light bulbs because the base can separate from the connector, posing an electrical shock hazard.

    Product
    ZapBulb mosquito zapper LED light bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V651000·2016-09-08

    GM Recalls Vehicles for Frontal Air Bag Software Defect

    General Motors is recalling 2014-2017 Chevrolet, GMC, Cadillac, and Buick vehicles because a software defect may prevent frontal air bags and seat belt pretensioners from deploying in a crash.

    Product
    GMC — GMC, CHEVROLET, CADILLAC SIERRA 3500, SUBURBAN, CHEVEROLET SS, SPARK EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V650000·2016-09-08

    Pleasant Valley T@B Travel Trailer Propane Hose Recall

    Pleasant Valley is recalling 2013-2017 T@B travel trailers with 3-way refrigerators due to a rubber gas hose that may wear and leak propane, increasing fire risk.

    Product
    PLEASANT VALLEY — PLEASANT VALLEY T@B TRAVEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1572-2016·2016-09-07

    Hy-Vee Recalls Maytag Blue Cheese Due to Listeria Risk

    Hy-Vee Stores Inc is recalling Maytag blue cheese products due to potential Listeria monocytogenes contamination. The recall affects specific repackaged wheels and cuts sold in eight states.

    Product
    Whole wheels and cuts of Maytag blue cheese re-packaged in foil or clear plastic wrap with scale labels in various weights. Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-2009-2016·2016-09-07

    Raw Pistachios Recalled Due to Potential Salmonella Contamination

    International Foodsource LLC is recalling raw shelled pistachios due to potential Salmonella contamination found in FDA testing.

    Product
    IFS Web Bulk Pistachio Raw Shelled 80% Wholes Net Wt. 30 lb. (13 kg) International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429239630
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2025-2016·2016-09-07

    Let's Do Lunch Recalls Chili Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling specific lots of Chili Dog, Low Fat/Low Sodium due to potential Listeria monocytogenes contamination.

    Product
    Chili Dog, Low Fat/Low Sodium Product ID 952000
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2001-2016·2016-09-07

    General Mills Recalls Nature Valley Bars Due to Listeria Risk

    General Mills is voluntarily recalling Nature Valley Protein Chewy Bars and Simple Nut Bars due to potential Listeria monocytogenes contamination from sunflower kernels.

    Product
    Nature Valley Protein Chewy Bars, Honey, Peanut & Almond with Pumpkin Seeds, Carton UPC 000-16000-47196, Case UPC 100-16000-47196, 5 bars/carton, 5-1.42 OZ (40 g)BARS, NET WT 7.1 OZ (201 g).
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2027-2016·2016-09-07

    Let's Do Lunch Recalls All American Cheeseburgers for Listeria Risk

    Let's Do Lunch, Inc. is recalling All American Cheeseburgers due to potential Listeria monocytogenes contamination. The product was distributed in nine U.S. states.

    Product
    All American Cheeseburger Product ID 470007
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2029-2016·2016-09-07

    Let's Do Lunch Recalls BBQ Rib Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling 687 cases of BBQ Rib Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed to nine U.S. states.

    Product
    BBQ Rib Sandwich Product ID C46007, 460007
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2006-2016·2016-09-07

    International Foodsource Recalls Raw Pistachios Due to Salmonella Risk

    International Foodsource, LLC is recalling raw pistachios because FDA testing found Salmonella contamination.

    Product
    Sam International Bulk Raw Whole Pistachio 80% VP Net Wt. 30 lb Packaged in Boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1999-2016·2016-09-07

    General Mills Recalls Nature Valley Bars Due to Listeria Risk

    General Mills is voluntarily recalling Nature Valley Simple Nut Bars and Protein Chewy Bars due to potential Listeria monocytogenes contamination from sunflower kernels.

    Product
    Nature Valley Simple Nut Bars, Almond, Cashew & Sea Salt, Carton UPC 000-16000-46474, Case UPC 100-16000-46474, 4 bars/carton, 4 1.17 OZ (33 g) BARS, NET WT 4.68 OZ (132 g). Nature Valley Simple Nut Bars, Almond, Cashew & Sea Salt, Carton UPC 000-16000-41301, Case UPC 00
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2028-2016·2016-09-07

    Let's Do Lunch Recalls Beef Sausage & Cheese Mini Bagel Sandwiches

    Let's Do Lunch, Inc. is recalling Beef Sausage & Cheese Mini Bagel Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed in nine U.S. states.

    Product
    Beef Sausage & Cheese Mini Bagel Sandwich Product ID C80916
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2033-2016·2016-09-07

    Let's Do Lunch Recalls All American Burger for Listeria Risk

    Let's Do Lunch, Inc. is recalling 590 cases of All American Burger due to potential Listeria monocytogenes contamination.

    Product
    All American Burger Product ID 470007, C47007
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2022-2016·2016-09-07

    Awrey's Bakery Recalls Deep Chocolate Sheet Cakes for Undeclared Walnuts

    Minnie Marie Bakers, Inc. dba Awrey's Bakery is recalling Deep Chocolate Sheet Cakes in Ohio due to undeclared walnuts, posing a risk to those with tree nut allergies.

    Product
    Deep Chocolate Sheet Cake 8x12 28.125 lb case 20, 22.5 oz cakes per case
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2026-2016·2016-09-07

    Let's Do Lunch Recalls Cheeseburger Sliders for Listeria Risk

    Let's Do Lunch, Inc. is recalling 2,085 cases of Cheeseburger Sliders due to potential Listeria monocytogenes contamination. The product was distributed to nine U.S. states.

    Product
    Cheeseburger Sliders Product ID C47220, 470220
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2011-2016·2016-09-07

    Pearson Foods Recalls Packaged Kale Due to Salmonella Contamination Risk

    Pearson Foods Inc. is voluntarily recalling specific lots of packaged shredded kale because they may be contaminated with Salmonella.

    Product
    Kale, 4/ 1 lb, & 1 /2 lb shredded packaged in plastic, keep refrigerated
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-2020-2016·2016-09-07

    Awrey's Bakery Recalls White Sponge Cakes Due to Undeclared Walnuts

    Minnie Marie Bakers, Inc. dba Awrey's Bakery is recalling White Sponge Cakes in Ohio because they may contain undeclared walnuts, posing a risk to people with tree nut allergies.

    Product
    White Sponge Cake 8x12 30 lb case 20, 24oz cakes per case
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2031-2016·2016-09-07

    Let's Do Lunch Recalls Beef Sausage Breakfast Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling 167 cases of Beef Sausage Breakfast Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed to nine U.S. states.

    Product
    Beef Sausage Breakfast Sandwich Product ID C99018
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2000-2016·2016-09-07

    General Mills Recalls Nature Valley Bars Due to Listeria Risk

    General Mills is voluntarily recalling Nature Valley Simple Nut Bars and Protein Chewy Bars due to potential Listeria monocytogenes contamination from sunflower kernels.

    Product
    Nature Valley Simple Nut Bars , Roasted Peanut & Honey, Carton UPC 000-16000-46475, Case UPC 100-16000-46475, 4 - 1.17 OZ (33 g) BARS, NET WT 4.68 OZ (132 g), 4 bars/carton. Nature Valley Simple Nut Bars, Roasted Peanut & Honey. Carton UPC 000-16000-41308, Case UPC 100-1
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2002-2016·2016-09-07

    General Mills Recalls Nature Valley Protein Bars for Listeria Risk

    General Mills is voluntarily recalling Nature Valley Protein Chewy Bars and Simple Nut Bars due to potential Listeria monocytogenes contamination from sunflower kernels.

    Product
    Nature Valley Protein Chewy Bars, Peanut, Almond, & Dark Chocolate, Carton UPC 000-16000-45724, Case UPC 100-16000-45724, 5 bars/carton, , 5-1.42 OZ (40g)BARS, NET WT 7.1 OZ (201g).
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-1573-2016·2016-09-07

    Hy-Vee Recalls Maytag Blue Cheese Crumbles Due to Listeria Risk

    Hy-Vee Stores Inc is recalling Maytag Blue cheese crumbles due to potential Listeria monocytogenes contamination. The product was sold in eight states.

    Product
    Maytag Blue cheese crumbles re-packaged and sold in plastic containers with scale labels in various weights. Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001.
    Category
    Food
    Distribution
    8 states
  • CriticalFDA (Food)·F-2032-2016·2016-09-07

    Let's Do Lunch Recalls Chicken Double Dogs for Listeria Risk

    Let's Do Lunch, Inc. is recalling Chicken Double Dogs on Whole Grain Bun due to potential Listeria monocytogenes contamination. The product was distributed to nine U.S. states.

    Product
    Chicken Double Dogs on Whole Grain Bun Product ID 809021
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2021-2016·2016-09-07

    Awrey's Bakery Recalls Devils Food Sheet Cakes Due to Undeclared Walnuts

    Minnie Marie Bakers, Inc. dba Awrey's Bakery is recalling Devils Food Sheet Cakes because they may contain undeclared walnuts, posing a risk to people with tree nut allergies.

    Product
    Devils Food Sheet Cake 8x12 Mega 28.125 lb case 20, 2 2.5oz cakes per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2016-2016·2016-09-07

    Hampton Creek Muffin Mix Recalled for Salmonella in Coconut Milk Powder

    Hampton Creek Foods is recalling JUST Chocolate Chunk Muffin Mix because a positive test result for Salmonella was found in the coconut milk powder used in manufacturing.

    Product
    JUST Chocolate Chunk Muffin Mix; NET WT 20.8 oz. (1 lb 4.8 oz) 590 g); UPC 8 54829 00656 5. Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, n
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2676-2016·2016-09-07

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.

    Product
    STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2008-2016·2016-09-07

    IFS Raw Shelled Pistachios Recalled for Potential Salmonella Contamination

    International Foodsource LLC is recalling raw shelled pistachios due to potential Salmonella contamination found in FDA testing.

    Product
    IFS Club Bag Pistachio Raw Shelled 80% Wholes Net Wt. 3 lb. (1 kg) International Foodsource LLC 52 Richboynton Rd. Dover NJ 07801 UPC 790429243026
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2016·2016-09-07

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.

    Product
    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2012-2016·2016-09-07

    Pearson Foods Recalls Packaged Kale for Potential Salmonella Contamination

    Pearson Foods is voluntarily recalling specific lots of packaged kale due to potential Salmonella contamination. The product was distributed in Illinois, Michigan, and Wisconsin.

    Product
    Nappa Shredded 2/5 lb, packaged in plastic, keep refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2023-2016·2016-09-07

    Awrey's Bakery Recalls Chocolate Roll Cakes Due to Undeclared Walnuts

    Minnie Marie Bakers, Inc. dba Awrey's Bakery is recalling Chocolate Roll Cakes in Ohio because they may contain undeclared walnuts, posing a risk to people with tree nut allergies.

    Product
    Chocolate Roll Cake 15x24 22 lb case 8, 2 lb 12 oz cakes per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2019-2016·2016-09-07

    Hampton Creek Devil's Food Cake Mix Recalled for Salmonella

    Hampton Creek Foods is recalling Devil's Food Cake Mix because a positive test found Salmonella in the coconut milk powder used in manufacturing.

    Product
    JUST Devil's Food Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567 g); UPC 8 54829 00643 5. Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin,
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V647000·2016-09-07

    Volkswagen and Audi Recall 2015-2016 Models for Fuel Leak Fire Risk

    Volkswagen is recalling 2015-2016 Golf, GTI, and Audi A3 vehicles because a faulty fuel pump may cause leaks that increase fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI GOLF, GTI, A3 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2016·2016-09-07

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Due to Fire Risk

    Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer because flammable liquids may contact electrical components, posing a fire hazard.

    Product
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2007-2016·2016-09-07

    Raw Pistachio Kernels Recalled Due to Salmonella Contamination

    International Foodsource LLC is recalling 9,756 bags of Valued Natural Raw Pistachio Kernels due to potential Salmonella contamination.

    Product
    Valued Natural Raw Pistachio Kernels Net Wt 5 oz. (141 g) International Foodsource LLC 52 Richboynton, Rd. Dover, NJ 07801 UPC 790429241428
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2030-2016·2016-09-07

    Let's Do Lunch Recalls Chicken Patty Sandwiches for Listeria Risk

    Let's Do Lunch, Inc. is recalling Chicken Patty Sandwiches on a Whole Grain Bun due to potential Listeria monocytogenes contamination. The product was distributed in nine U.S. states.

    Product
    Chicken Patty Sandwich on a Whole Grain Bun Product ID 400003
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·16V646000·2016-09-07

    Audi Recalls 2012-2013 A6 and A7 for Fuel Hose Leak Risk

    Volkswagen Group of America is recalling 28,249 Audi A6 and A7 vehicles because a fuel hose may degrade and leak, increasing fire risk.

    Product
    AUDI — AUDI A6, A7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2036-2016·2016-09-07

    Warren Produce Recalls Serrano Peppers Due to Salmonella Contamination

    Warren Produce is recalling 14,000 pounds of Primo Fresh Serrano Peppers because the product tested positive for Salmonella.

    Product
    Primo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX packaged in 1/4 bushel waxed cardboard boxes, 1 1/9 bushel waxed cardboard boxes, 10 lb waxed cardboard boxes, 5 lb waxed cardboard boxes and 35 lb RPC crates.
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-2681-2016·2016-09-07

    Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard

    Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.

    Product
    PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-1997-2016·2016-09-07

    Sanwa Organic Hot Finger Peppers Recalled for Salmonella Contamination

    Sanwa International Wholesale Foods is recalling Organic Hot Finger Peppers sold in Florida due to a positive test for Salmonella.

    Product
    Organic Hot Finger Peppers (Florida), sold in 0.5-1 lb plastic bags. Each case will hold approximately 15-20 bags.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2677-2016·2016-09-07

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.

    Product
    CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16C007000·2016-09-07

    Evenflo Recalls Evolve 3-in-1 Booster Seats Due to Harness Loosening Risk

    Evenflo is recalling specific Evolve 3-in-1 Combination Booster Seats because children can access a button to loosen the harness, increasing injury risk in a crash.

    Product
    CHILD SEAT:HARNESS:STRAP/WEBBING recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2016·2016-09-07

    Medical Vision Ab Recalls Double Pump RF Patient Cassettes

    Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.

    Product
    Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2683-2016·2016-09-07

    Teleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking

    Teleflex Medical is recalling 2,700 MAQUET Servo Humidifier 163 units because the ISO female connector may crack. The units were distributed to Florida, Kansas, and West Virginia.

    Product
    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2684-2016·2016-09-07

    Integra Recalls Spinal Trays Due to Lidocaine Component Issue

    Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.

    Product
    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2672-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2691-2016·2016-09-07

    Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

    Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

    Product
    HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2688-2016·2016-09-07

    Invivo Breast MRI Auxiliary Table Recalled Due to Missing Diode

    Invivo Corporation is recalling three breast MRI auxiliary tables because a missing diode may cause the coil to overheat.

    Product
    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2708-2016·2016-09-07

    Alcon AcrySof IQ Intraocular Lens Recall Due to Delivery System Defect

    Alcon is recalling specific lots of AcrySof IQ intraocular lenses because the ULTRASERT delivery system may cause the lens to become lodged during implantation.

    Product
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients fol
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2670-2016·2016-09-07

    Philips Recalls UNIQ 1.0 Fluoroscopy Systems Due to Power Supply Failures

    Philips is recalling 1,536 UNIQ 1.0 fluoroscopy systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2016·2016-09-07

    Elekta Monaco RTP System Software Recall for Contour Deletion Error

    Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.

    Product
    Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-2003-2016·2016-09-07

    Republic of Tea Recalls Organic Turmeric Ginger Green Tea Due to Salmonella

    Republic of Tea is recalling Organic Turmeric Ginger Spice of Life Green Tea because a supplier reported a positive Salmonella result in the organic ginger used.

    Product
    Organic Turmeric Ginger Spice of Life Green Tea; Organic Blend of Tumeric, Spices, Natural Honey Flavor and Fine China Green Tea 50 CT Tin: Net Wt. 2.65 oz.. (75G) UPC: 7-42676-40355-5. The Republic of Tea
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2709-2016·2016-09-07

    Merge Cardio software recall due to incorrect patient data saving

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2016·2016-09-07

    Mindray A7 Anesthesia Delivery System Recalled for Potential Oxygen Leak

    Mindray is recalling 167 A7 Anesthesia Delivery Systems due to a potential leak on the back-up oxygen and air cylinder yokes.

    Product
    A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1992-2016·2016-09-07

    Tippins Cream Cheese Pie Base Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 60 cases of 9-inch cream cheese pie bases because they may contain low levels of peanut residue.

    Product
    Tippins 9" Cream Cheese Base packaged in ?. UPC code is 680816002711. Packaged in 18 pie bases per case. Shipped frozen.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2039-2016·2016-09-07

    Lactalis Recalls President Pub Cheese Spread for Undeclared Wheat

    Lactalis American Group is recalling President brand Pub Cheese Spread due to undeclared wheat. The product was distributed in six states.

    Product
    PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactalis American Group, Inc. Buffalo, NY 14220 --- The product is manufactured approximately every 5 weeks (from 11/02/2015 to 04/06/2016).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2710-2016·2016-09-07

    BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.

    Product
    BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2669-2016·2016-09-07

    Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk

    Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2016·2016-09-07

    DeRoyal recalls two custom surgical kits with potential sterility defect

    DeRoyal Industries Inc is recalling two custom surgical kits containing a BARD Toomey Irrigation Syringe due to a possible package slit that may affect sterility.

    Product
    DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2673-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2674-2016·2016-09-07

    Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reduc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2016·2016-09-07

    DeRoyal Recalls Custom Surgical Kits Due to Sterility Concerns

    DeRoyal Industries is recalling 26 custom surgical kits containing Bard Toomey Irrigation Syringes due to a possible package defect that may affect sterility.

    Product
    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2713-2016·2016-09-07

    Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp

    Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.

    Product
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2687-2016·2016-09-07

    Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise

    Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.

    Product
    Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-2034-2016·2016-09-07

    Hampton Creek White Cake Mix Recalled for Salmonella Risk

    Hampton Creek Foods is recalling JUST White Cake Mix because a positive test for Salmonella was found in the coconut milk powder used in its manufacturing.

    Product
    JUST White Cake Mix; NET WT 20 oz. (1 lb 4 oz) 567 g); UPC 8 54829 00688 6. Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin, reduced Iron, thiamin
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2035-2016·2016-09-07

    Hampton Creek Cinnamon Roll Coffee Cake Mix Recalled for Salmonella

    Hampton Creek Foods is recalling JUST Cinnamon Roll Coffee Cake Mix because a positive test for Salmonella was found in the coconut milk powder used in its manufacturing.

    Product
    JUST Cinnamon Roll Coffee Cake Mix; NET WT 26.9 oz. (1 lb 10.9 oz) 762 g); UPC 8 54829 00644 2. Ingredients: Cake Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1994-2016·2016-09-07

    Tippin's Key Lime Pie Bases Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 8-inch Key Lime Pie Bases because they may contain low levels of peanut residue. The product was distributed to seven states.

    Product
    Tippins 8" Key Lime Base packaged in ?. UPC code is 680816001851. Packaged in 12 pie bases per case. Shipped frozen. Net wt. 21oz each.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1998-2016·2016-09-07

    Wonder Meal Recalled for Undeclared Milk Allergen

    FKC International is recalling Wonder Meal bottles due to undeclared milk from whey protein. Consumers with milk allergies should not consume the product.

    Product
    Wonder Meal Net Weight 455 grams 15.75 oz UPC Code: 6 03808 12813
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2013-2016·2016-09-07

    Big Pig Bacon Seasoning Salt Recalled for E. coli O121 Contamination Risk

    J&D's Down Home Enterprises is recalling Big Pig Original Bacon Flavored Seasoning Salt due to potential E. coli O121 contamination.

    Product
    Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz plastic jars, 3 jars per case. UPC 98300 00110
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1991-2016·2016-09-07

    Tippin's Key Lime Pie Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 8-inch Key Lime Pies because an ingredient may contain low levels of peanut residue.

    Product
    Tippins 8" Key Lime Pie packaged in aluminum pie plates with plastic covers. The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106. UPC code is 680816050057. Packaged in 8 pies per case. Shipped frozen.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2017-2016·2016-09-07

    Hampton Creek Recalls JUST Yellow Cake Mix Due to Salmonella Risk

    Hampton Creek Foods is recalling JUST Yellow Cake Mix because a positive test for Salmonella was found in the coconut milk powder used to make it.

    Product
    JUST Yellow Cake Mix; NET WT 20 z. (1 lb 4oz) 567 g); UPC 8 54829 00642 8. Ingredients: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin, reduced Iron, thiamine
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2018-2016·2016-09-07

    Hampton Creek Blueberry Muffin Mix Recalled for Salmonella Risk

    Hampton Creek Foods is recalling JUST Blueberry Muffin Mix because a positive test for Salmonella was found in the coconut milk powder used to make it.

    Product
    JUST Blueberry Muffin Mix; NET WT 23.3 oz. (1 lb 7.3 oz) 660 g); UPC 8 54829 00685 5. Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2038-2016·2016-09-07

    General Mills Recalls Frozen Beyond Meat Vegetarian Indian Curry

    General Mills is voluntarily recalling frozen Beyond Meat Vegetarian Indian Curry with Beyond Chicken due to potential Listeria monocytogenes contamination in frozen peas.

    Product
    Case: Beyond Meat Vegetarian Indian Curry with Beyond Chicken, GMI Item # 46671000, Frozen. Net WT 5 lbs (2.2 KG) 8 - 10 oz (263 g). Individual items: 21 Grams of Plant Protein, Vegetarian Indian Curry with Beyond Chicken, Net WT 10 oz (263 g), UPC is 000-16000-46671 , Keep F
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2704-2016·2016-09-07

    Siemens ADVIA Chemistry XPT Recall for A1c Calculation Error

    Siemens is recalling ADVIA Chemistry XPT systems due to a software error that causes falsely low Hemoglobin A1c results in IFCC units.

    Product
    ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-2004-2016·2016-09-07

    Republic of Tea Organic Turmeric Ginger Green Tea Recalled for Salmonella

    Republic of Tea is recalling Organic Turmeric Ginger Green Tea because the supplier reported a positive Salmonella result in the organic ginger ingredient.

    Product
    The Republic of Tea - Organic Turmeric Ginger: Green Tea Ingredients: Organic Turmeric, Organic Green Tea, Organic Ginger, Organic Cinnamon and Natural Honey Flavor Packed in 250 CT Bulk Bag (375 g) and and 50 count refill bag. (75 g) UPC - 250 bulk bag: 7-42676-30655-9
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2024-2016·2016-09-07

    Euro Custard Cake Recalled for Undeclared Milk Allergen

    Eastland Food Corporation is recalling Euro Custard Cake because the label failed to declare milk as an allergen. No adverse incidents have been reported.

    Product
    Euro Custard Cake, Plastic wrapped cardboard container (Net Wt. 7.20 oz.)
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1995-2016·2016-09-07

    Tippin's Mini Key Lime Pie Bases Recalled for Potential Peanut Residue

    Tippin's Gourmet Pies is recalling 32 cases of Mini Key Lime Pie Bases because they were manufactured with an ingredient that may contain low levels of peanut residue.

    Product
    Tippins Mini Key Lime Base packaged in ?. UPC code is 680816000106. Packaged in 30 pie bases per case. Shipped frozen. Net wt. 11oz each.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2680-2016·2016-09-07

    Waismed Recalls NIO-P Instant Intraosseous Access Devices Due to Malfunction

    Waismed is recalling 50 units of NIO-P devices because a needle failed to release as expected during operation, posing a risk of injury.

    Product
    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P i
    Category
    Medical Device
    Distribution
    4 states

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