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.

Which agencies issued them

401–500 of 734

  • HighFDA (Food)·F-2117-2016·2016-09-21

    Hostess Zingers Raspberry Recalled for Unlabeled Peanut Allergen

    Hostess Brands is recalling Zingers Raspberry cakes because they were made with flour containing peanut allergen but are not labeled to contain peanuts.

    Product
    Iced Raspberry cake with creamy filling, packaged as Hostess Zingers Raspberry in 10-ct multi-packs of individual cakes, net wt. 13.40oz (360 g), UPC 888109110604; 6-ct. single serving fun size snack packs, 3 cakes per pack net wt. 4.02oz. (108g), UPC 888109010089; with the respo
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2234-2016·2016-09-21

    Pictsweet Mixed Vegetables Recalled for Possible Listeria Contamination

    The Pictsweet Company is recalling Steam'able Mixed Vegetables due to possible Listeria monocytogenes contamination in bulk vegetable ingredients.

    Product
    Pictsweet(R) Steam'able Mixed Vegetables, NET WT 10 OZ. (283g), DISTRIBUTED BY THE PICTSWEET COMPANY, BELLS, TN 38305, UPC 7056097911
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2200-2016·2016-09-21

    National Frozen Foods Recalls IQF Peas and Carrots for Listeria Risk

    National Frozen Foods Corporation is recalling approximately 665,858 lbs of Not Ready to Eat IQF Peas and Carrots due to potential Listeria monocytogenes contamination.

    Product
    Not Ready to Eat, IQF Peas and Carrots. Products' labels contains Cooking Instructions. Bountiful Harvest Peas & Carrots, item # 22486-11902, case & label UPC 30822486119028, Net wt. 12/2.5 LB Bountiful Harvest Peas & Carrots, item # 22486-11913, case & label UPC 008224
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2221-2016·2016-09-21

    General Mills Recalls Flour Products Due to E. coli O121 Outbreak Link

    General Mills is recalling flour products due to a potential link to a multistate E. coli O121 outbreak. The company states the bacteria has not been found in its products or facilities.

    Product
    Expanded Recall: 50 lb Wondra Enriched Unmalted Flour Unit UPC 100-16000-54380 Code Dates/Production Dates 04NOV2015KC, 05NOV2015KC
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2132-2016·2016-09-21

    Panzanella Bread Recalled for Undeclared Soy and Wheat Allergens

    Golden Crown Bakery is recalling all Panzanella bread products due to undeclared soy and wheat allergens and missing ingredient labels.

    Product
    Three Seed - PAN 3 lbs. SLC Bread No ingredient statement on label. No labeling agreement with consignees. Some of the packages list the name of the bread in the paper bag. The 3lb designation is for dough weight, not net wt. Sliced breads are individually wrapped in in pla
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2204-2016·2016-09-21

    Sunrise Foods Recalls Jump Dark Stir Fry Sauce Due to E. Coli Risk

    Sunrise Foods Inc is recalling Jump Dark Stir Fry Sauce because the flour used in the product may be contaminated with E. Coli.

    Product
    Jump Dark Stir Fry Sauce .5 gallon plastic bag Ingredients: WATER, SOY SAUCE***OYSTER FLAVORED SAUCE***MUSHROOM SOY SAUCE***SOYBEAN OIL***ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY JUMP PROPRIETARY PRODUCT Prepared
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-2194-2016·2016-09-21

    Good Neighbor Pharmacy Cranberry Tablets Recalled for Labeling Errors

    Reese Pharmaceutical is recalling Good Neighbor Pharmacy Cranberry Tablets because the label omits calcium and lists the wrong serving size.

    Product
    Good Neighbor Pharmacy Cranberry Tablets, Cranberry Supplement 450mg. Urinary Health. Tablets are packed in a labeled carton, 50 tablets per carton. Distributed by Amerisource Bergen 1300 Morris Drive Chesterbrook, PA 19087.
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2793-2016·2016-09-21

    Siemens Syngo Plaza PACS Recall for Measurement Display Suffix

    Siemens is recalling 101 Syngo Plaza PACS systems because a suffix on DICOM images may indicate that displayed measurements differ from actual values.

    Product
    Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2246-2016·2016-09-21

    Kill Cliff Strawberries & Cream Protein Bars Recalled for Potential Mold

    Kill Cliff is recalling Strawberries & Cream Protein Bars because they may contain mold. The recall started on June 21, 2016.

    Product
    KC (Kill Cliff) Strawberries & Cream Protein Bars, 2.1oz (60g) individually wrapped bar (in cases of 12-2.1 oz (60g) bars).
    Category
    Food
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-1501-2016·2016-09-21

    Amerisource Recalls bupropion Hydrochloride Tablets for Dissolution Failure

    Amerisource Health Services is recalling 2,626 bottles of bupropion hydrochloride extended-release tablets due to failed dissolution specifications.

    Product
    buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2781-2016·2016-09-21

    Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error

    Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.

    Product
    CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·085-2016·2016-09-21

    Black Forest Ham Products Recalled Due To Possible Rubber Contamination

    502 Boundary Blvd. is recalling Black Forest Ham products due to possible rubber contamination. No adverse reactions have been reported.

    Product
    502 Boundary Blvd. Recalls Black Forest Ham Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2771-2016·2016-09-21

    Arrow International Recalls Select Kit Products Due to Molding Abnormality

    Arrow International is recalling 6,121 units of Select Kit products due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2776-2016·2016-09-21

    Biosense Webster Recalls CARTO 3 EP Navigation Systems in China

    Biosense Webster is voluntarily re-installing 338 CARTO 3 EP Navigation Systems in China, Hong Kong, and Brazil that were moved without required testing.

    Product
    CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides i
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2777-2016·2016-09-21

    Integra Meshed Dermal Regeneration Template Recalled for Calculation Error

    Integra LifeSciences is recalling 14 packages of Meshed Dermal Regeneration Template due to an incorrect calculation of peel strength test results.

    Product
    Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2782-2016·2016-09-21

    Trinity Biotech Captia Measles IgM Test Kit Recalled for QC Failure

    Clark Laboratories is recalling specific lots of the Captia Measles IgM test kit because the product failed quality control stability testing.

    Product
    Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2201-2016·2016-09-21

    Van Vogt Mill House Salad Dressing Recalled for Undeclared Sulfites

    Van Vogt Creations is recalling Mill House Salad Dressing & Gourmet Sauce due to undeclared sulfites. The product was sold at the firm's retail store in Washington.

    Product
    Mill House Salad Dressing & Gourmet Sauce 12 FL OZ Plastic Bottles Ingredients: canola oil, garlic, lemon juice, water, salt, pepper.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2791-2016·2016-09-21

    Stryker Recalls Mislabelled T2 Supracondylar Nail System

    Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.

    Product
    Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Patholo
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2792-2016·2016-09-21

    Stryker Recalls Mislabelled Femoral and Tibial Nails

    Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.

    Product
    Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and corr
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2773-2016·2016-09-21

    Arrow Single-Lumen Catheters Recalled for Packaging Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Single-Lumen Catheters due to a molding abnormality in the packaging component supplied by a vendor.

    Product
    Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2775-2016·2016-09-21

    Thermo Fisher Recalls Endura MD Mass Spectrometer Software Due to Data Accuracy Defect

    Thermo Fisher is recalling Endura MD Mass Spectrometer software versions 1.0 and 1.0 SP1 because a defect affects data accuracy.

    Product
    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and qua
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2780-2016·2016-09-21

    Mentor Artoura Breast Tissue Expander Recall for Packaging Error

    Mentor Texas, LP. is recalling 48 Artoura Breast Tissue Expanders because CPX4 devices may have been packaged in Artoura boxes.

    Product
    Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2255-2016·2016-09-21

    Misono Food Recalls Smoked Herring Due to HACCP Violations

    Misono Food Ltd is recalling Smoked Herring Slow Food because the foreign processor failed to meet HACCP requirements. The product was distributed to one retailer in New York City.

    Product
    Smoked Herring Slow Food (Quality: Polar Golden Presidia), Net weight 0.378 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2774-2016·2016-09-21

    Arrow Select Kit Recall Due to Component Molding Abnormality

    Arrow International Inc. is recalling 6,121 Arrow Select Kit units due to a component molding abnormality reported by a supplier.

    Product
    Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2770-2016·2016-09-21

    Sysmex Fluorocell PLT Reagent Recalled for Potential Low Platelet Results

    Sysmex America Inc is recalling Fluorocell PLT reagent because it may produce falsely low platelet results on Sysmex XN-Series analyzers.

    Product
    Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2829-2016·2016-09-21

    AirStrip Sense4Baby Fetal Monitor Recalled for Detaching Belt Clip

    AirStrip Technologies is recalling 42 Sense4Baby Model C fetal monitors because the belt clip may detach, exposing electronic components.

    Product
    AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doct
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2772-2016·2016-09-21

    Arrow Select Kit Ultrasound Catheters Recalled for Packaging Molding Abnormality

    Arrow International Inc. is recalling 6,121 units of Arrow Select Kit ultrasound catheters due to a component molding abnormality in the packaging.

    Product
    Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2794-2016·2016-09-21

    Siemens Syngo.Plaza VB 10 A PACS Recall for Measurement Suffix Display

    Siemens is recalling 101 Syngo.Plaza VB 10 A image processing systems because a suffix on DICOM images may indicate that displayed measurement values differ from real values.

    Product
    Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2778-2016·2016-09-21

    Alere LDX Optical Check Cassettes Recalled for Incorrect Expiration Date

    Alere San Diego, Inc. is recalling LDX Optical Check Cassettes because the expiration date on the magnetic strip does not match the labeled date.

    Product
    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2779-2016·2016-09-21

    Biomerieux Recalls VIDAS NT-pro-BNP Kits Due to Packaging Error

    Biomerieux is recalling 229 VIDAS NT-pro-BNP kits because they contain the incorrect number of control vials.

    Product
    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA techniqu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2804-2016·2016-09-21

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Calibrator Kit 31

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.

    Product
    The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2100-2016·2016-09-21

    WTI All Natural DV Recalled for Foreign Wood Matter

    WTI, Inc. is recalling 308,140 lbs of All Natural DV because wood pieces were found in the product. The affected lots were distributed in Illinois and Canada.

    Product
    WTI (World Technology Ingredients) DV, All Natural, 35 lbs./15.9 kg, WTI, Inc., 281 MLK Ave., Jefferson, GA 30549.
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·16V678000·2016-09-20

    New Flyer Recalls 2016 XN60 and XN40 Buses for CNG Defect

    New Flyer is recalling 38 model year 2016 XN60 and XN40 transit buses because a pressure relief device may fracture, releasing high-pressure gas and increasing fire risk.

    Product
    NEW FLYER — NEW FLYER XN60, XN40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·084-2016·2016-09-20

    Speedy Foods Recalls Chicken Spring Rolls Due To Undeclared Egg Allergen

    Speedy Foods is recalling approximately 920 pounds of chicken spring rolls because they contain eggs, a known allergen not declared on the label.

    Product
    Speedy Foods LLC — Speedy Foods Recalls Chicken Spring Rolls Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·16V679000·2016-09-20

    Ducati Recalls XDiavel Motorcycles for Loose Final Drive Pulley Nut

    Ducati is recalling 2016-2017 XDiavel motorcycles because a loose final drive pulley nut may cause loss of power to the rear wheel, increasing crash risk.

    Product
    DUCATI — DUCATI XDIAVEL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16267·2016-09-20

    Denon Recalls HEOS 1 Go Pack Battery Packs for Fire and Burn Hazards

    Denon is recalling HEOS 1 Go Pack rechargeable battery packs because they can overheat, posing fire and burn hazards. No injuries have been reported.

    Product
    HEOS 1 Go Pack rechargeable battery packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V680000·2016-09-20

    Porsche Recalls 2017 Macan Models Due to Front Suspension Defect

    Porsche is recalling 2017 Macan models because front anti-rollbar links may move out of position, causing oversteer and increasing crash risk.

    Product
    PORSCHE — PORSCHE MACAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E073000·2016-09-20

    Porsche Brake Fluid Recall Due to Missing DOT 4 Labeling

    Porsche is recalling specific 1L and 30L brake fluid containers manufactured between September 2015 and August 2016 because they lack the required 'DOT 4' label, posing a risk of incompatible fluid use.

    Product
    SERVICE BRAKES, HYDRAULIC:FLUID recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V675000·2016-09-19

    Mitsubishi Recalls 2017 Mirage Vehicles for Headlight Adjustment Defect

    Mitsubishi is recalling 2017 Mirage vehicles with HID headlamps because the horizontal adjustment clips may not be secured, potentially reducing visibility or blinding oncoming drivers.

    Product
    MITSUBISHI — MITSUBISHI MIRAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·083-2016·2016-09-17

    Gallo Meats Recalls Sausage, Beef, and Lamb Products Lacking Federal Inspection

    Gallo Meats LLC is recalling approximately 82 pounds of sausage, beef, and lamb products produced without federal inspection. The hot Italian sausage may also contain undeclared allergens.

    Product
    Gallo Meats LLC. Recalls Sausage, Beef and Lamb Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·082-2016·2016-09-16

    Bunge's Meats Recalls Pork Sausage Products Due to Water Contamination

    Bunge's Meats is recalling pork sausage products made with water that failed EPA drinking water standards due to Coliform bacteria.

    Product
    Bunge&#039;s Meats Recalls Pork Products Formulated With Water That Did Not Meet EPA Drinking Water Standards
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·081-2016·2016-09-16

    Tucson Tamale Wholesale Recalls Beef Tamales Lacking Federal Inspection

    Tucson Tamale Wholesale Company is recalling 915 pounds of beef tamales because the meat was produced without federal inspection. No illnesses have been reported.

    Product
    Tucson Tamale Wholesale Company LLC — Tucson Tamale Wholesale Company, LLC Recalls Beef Tamale Products Containing Meat Produced Without Benefit of Federal Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V673000·2016-09-16

    Forest River Recalls 2017 Salem and Wildwood Trailers for Incorrect Tire Placards

    Forest River is recalling 2017 Salem and Wildwood recreational trailers because the Federal Placard lists incorrect tire and rim specifications, which may lead to under-inflation and increased crash risk.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V672000·2016-09-16

    Toyota Recalls 2016 Prius Vehicles Due to Air Bag Inflation Error

    Toyota is recalling 7,817 model year 2016 Prius vehicles because a manufacturing error may cause the front passenger air bag to partially inflate unintentionally.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V671000·2016-09-16

    Jayco Recalls 2017 Octane Travel Trailers for Incorrect Tire Labels

    Jayco is recalling 2017 Octane Super Lite travel trailers because incorrect tire labels may lead to over-inflation and sudden tire failure.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER OCTANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V668000·2016-09-15

    Chrysler Recalls Vehicles Due to Potential Airbag and Seat Belt Failure

    Chrysler is recalling specific 2010-2014 models because a module may short circuit, preventing airbags and seat belt pretensioners from deploying in a crash.

    Product
    JEEP — JEEP, DODGE, CHRYSLER COMPASS, CALIBER, PATRIOT, SEBRING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16264·2016-09-15

    Polaris Recalls Ranger 900 Vehicles Due to Fire and Burn Hazards

    Polaris is recalling about 42,500 model year 2014 Ranger 900 vehicles because a heat shield can fall off, creating fire and burn risks.

    Product
    Polaris Ranger 900 recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16266·2016-09-15

    Samsung Recalls Galaxy Note7 Smartphones Due to Fire and Burn Hazards

    Samsung is recalling Galaxy Note7 smartphones sold before September 15, 2016, because the lithium-ion battery can overheat and catch fire, posing a burn hazard.

    Product
    Samsung Galaxy Note7 smartphones sold prior to September 15, 2016
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·16265·2016-09-15

    GE Profile Top-Loading Clothes Washers Recalled for Fire Hazard

    GE Appliances is recalling about 222,000 Profile top-loading clothes washers because an electrical component can overheat and cause a fire.

    Product
    GE Profile™ top-loading clothes washers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V670000·2016-09-15

    2016 Mercedes-Benz and Freightliner Sprinter Seat Belt Bolt Recall

    Daimler Vans USA is recalling 2016 Mercedes-Benz and Freightliner Sprinter 2500 and 3500 vehicles because rear seat belt bolts may not be properly tightened.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V667000·2016-09-15

    Fiat 500 Recalled for Incorrect Spare Tire Pressure Label

    FCA US LLC is recalling 2016 Fiat 500 vehicles because the spare tire placard lists an inflation pressure exceeding the tire's maximum limit.

    Product
    FIAT — FIAT 500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16263·2016-09-15

    Bungee Chairs Recalled Due to Rivet Breakage and Fall Hazard

    Big 5 Sporting Goods is recalling Captiva Designs bungee chairs because rivets can break, posing a fall hazard. Consumers should stop using them and return them for a refund.

    Product
    Bungee chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V669000·2016-09-15

    Starcraft RV Recalls 2017 AR-ONE MAXX Trailers Due to Incorrect Axle Labeling

    Starcraft RV is recalling 40 model year 2017 AR-ONE MAXX LE trailers because the Federal label incorrectly states they have two axles instead of one, creating an overload risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AR-ONE MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2083-2016·2016-09-14

    Aldi Millville Protein Chew Bars Recalled for Listeria Risk

    Schulze & Burch Biscuit Co is recalling Aldi's Millville protein chew bars because a supplier reported Listeria monocytogenes in an ingredient.

    Product
    Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2082-2016·2016-09-14

    Aldi Millville Protein Chew Bars Recalled for Listeria Risk

    Schulze & Burch Biscuit Co is recalling Aldi's Millville dark chocolate peanut butter protein chew bars because a supplier reported Listeria monocytogenes in an ingredient.

    Product
    Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2699-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Base Components

    MicroPort Orthopedics is recalling Advance II Modular Tibial Base components due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2087-2016·2016-09-14

    ConAgra Recalls PF Chang's Shrimp Lo Mein Due to Metal Fragments

    ConAgra Frozen Foods is recalling PF Chang's Home Menu Shrimp Lo Mein because metal fragments were found in a raw ingredient used during manufacturing.

    Product
    PF Chang's Home Menu Brand Shrimp Lo Mein, UPC 3100067005, 22 oz bag, 4 bags per case, ConAgra Foods, Omaha, NE 68102
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2695-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2701-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2716-2016·2016-09-14

    Aribex Recalls NOMAD Pro X-Ray Systems Due to Battery Fire Risk

    Aribex Inc is recalling NOMAD Pro X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, melting, smoking, or ignition.

    Product
    NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Devices)·Z-2698-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sys
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·16V662000·2016-09-14

    Gillig Recalls 2014-2016 Low Floor Buses Due to Brake Hose Fraying

    Gillig is recalling 2014-2016 Low Floor transit buses because rear brake hoses can fray, potentially causing brake lockup or failure and increasing crash risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1586-2016·2016-09-14

    Schnucks Recalls Maytag Blue Cheese Due to Listeria Risk

    Schnucks Markets is recalling Maytag Blue cheese cut and wrapped in-store due to potential Listeria monocytogenes contamination. The product was sold in Missouri, Illinois, and Iowa.

    Product
    Maytag Blue cheese cut and wrapped in clear plastic wrap at store level, sold in various sizes (approximately 3-4 oz pieces), labeled with company issued Maytag Blue cheese label and Schnuck Markets scale label, UPC 0021806200000.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1482-2016·2016-09-14

    Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors

    Amerisource Health Services is recalling 2,276 cartons of 10 mg amphetamine tablets because blister cavities may contain more than one tablet.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 47 units of Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1487-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 126 cartons of amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain multiple capsules.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health Pa
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2696-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Sy
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2703-2016·2016-09-14

    MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening

    MicroPort Orthopedics is recalling 38 units of Advance II Modular Tibial Bases because they are experiencing a higher than expected revision rate due to component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2693-2016·2016-09-14

    MicroPort Advance II Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2768-2016·2016-09-14

    Bayer Certegra Workstation Recalled for Fire and Smoke Risk

    Bayer Healthcare is recalling 165 Certegra Workstations used with Medrad Stellant CT Injection Systems because they may produce smoke and sparks of fire.

    Product
    Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2697-2016·2016-09-14

    MicroPort Advance II Modular Tibial Base Recalled for Component Loosening

    MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.

    Product
    ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1498-2016·2016-09-14

    Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1489-2016·2016-09-14

    Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules

    Amerisource Health Services is recalling 115 cartons of 25 mg amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2717-2016·2016-09-14

    Aribex Recalls NOMAD Pro2 X-Ray Systems Due to Battery Fire Risk

    Aribex Inc is recalling 16,871 NOMAD Pro2 X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, smoke, or ignition.

    Product
    NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System, GB
    Category
    Medical Device
    Distribution
    52 states
  • SevereFDA (Drugs)·D-1495-2016·2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2069-2016·2016-09-14

    Nature Made Adult Gummies Recalled for Possible Salmonella Contamination

    Pharmavite is recalling specific lots of Nature Made adult gummies due to possible Salmonella contamination. Consumers should check lot numbers and stop using the product.

    Product
    Nature Made(R) adult gummies Multi for Her plus Omega-3, 150 count, UPC 0-31604-04275-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·16V663000·2016-09-14

    Smeal Recalls 2015-2016 Aerial Fire Apparatus Due to Touchscreen Defect

    Smeal is recalling 2015-2016 Aerial fire apparatus vehicles because touchscreen false activations may turn accessories on or off, increasing crash risk.

    Product
    SMEAL — SMEAL AERIAL FIRE APPARATUS, AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2721-2016·2016-09-14

    Elekta Medical Linear Accelerator Recall for Loose Drive Gear Joint

    Elekta is recalling 553 Medical Linear Accelerators because a loose joint between the drive gear and gantry base drive wheel can lead to fatigue failure of securing bolts.

    Product
    Medical Linear Accelerator
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·F-2059-2016·2016-09-14

    Pancake Mix Recalled for Undeclared Soy Allergen in Puerto Rico

    Productos La Finca, Inc. is recalling specific lots of Mr. Special Pancakes & Waffle Mix sold in Puerto Rico due to undeclared soy lecithin.

    Product
    Product label reads in part: "MR.SPECIAL PANCAKES***PANCAKES & WAFFLE MIX***Peso Neto/Net Weight 11 gr"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2088-2016·2016-09-14

    Innovative Food Processors Recalls Prime CAP Sugar Due to Metal Contamination

    Innovative Food Processors, Inc. is recalling specific lots of Prime CAP Sugar because of possible contamination by metal shavings.

    Product
    Prime CAP Sugar, S 95-135, Encapsulated Sugar. Ingredients: Sugar and Hydrogenated Palm Oil, #10040870, Net WT. 125 lbs. Poly lined cardboard drum. DIFP, Inc., 2125 Airport Dr., Ferial, MN 55021
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2736-2016·2016-09-14

    Philips BrightView XCT Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 424 BrightView XCT gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Model 882482, gamma camera for Single Photon Emission Computed Tomography (SPECT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2016·2016-09-14

    Philips BrightView X Gamma Camera Recalled for Software Defect

    Philips Medical Systems is recalling 117 BrightView X gamma cameras due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2062-2016·2016-09-14

    SuperMax Wheat Flour Recalled for Undeclared Soy Lecithin Allergen

    Productos La Finca, Inc. is recalling SuperMax Wheat Flour in Puerto Rico because the product contains undeclared soy lecithin, a major allergen.

    Product
    Product label reads in part: "SuperMax HARINA DE TRIGO***WHEAT FLOUR"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2731-2016·2016-09-14

    GE Healthcare Recalls SIGNA Creator and Explorer MRI Devices

    GE Healthcare is recalling SIGNA Creator and SIGNA Explorer MRI scanners due to an incorrect RF Power Monitor Function that could cause higher than expected thermal dose and localized heating to patients.

    Product
    GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-2037-2016·2016-09-14

    Odyssey King Crab Legs Recalled for Listeria Contamination

    Odyssey Enterprises Inc. is recalling Split Cooked King Crab Leg & Claw due to Listeria monocytogenes contamination. The product was distributed in Wisconsin.

    Product
    Split Cooked King Crab Leg & Claw, repacked by Odyssey, net wt. 20 lbs. per box, keep frozen. UPC 28575 96323 The label is read in parts: "***SPLIT COOKED KING CRAB LEG & CLAW***PRODUCT OF RUSSIA***PACKED IN U.S.A. ***NET WT. 20 LBS***KEEP FROZEN***PACKED FOR: ODYSSEY BY: NO
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2060-2016·2016-09-14

    Wheat Flour Recalled for Undeclared Soy Lecithin Allergen

    Productos La Finca, Inc. is recalling wheat flour in Puerto Rico because the product contains soy lecithin, an allergen not listed on the label.

    Product
    Product label reads in part: "MR.SPECIAL HARINA DE TRIGO***WHEAT FLOUR***Peso Neto/Net Weight 11 gr"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2766-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Localization Systems Due to Tip Breakage

    Hologic is recalling 535 units of SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12MR Handpiece Product Usage: The Sure Sight Obturator Introducer Localization System (ILS-OB) is a Hologic accessory kit. It is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2016·2016-09-14

    Maquet Operating Room Table Connecting Bracket Recall for Welded Joint Failure

    Maquet is recalling Connecting Bracket (Fixture) Devices because post-market surveillance reports indicate the welded joint between the square mount and the first fixable swivel joint is broken.

    Product
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2769-2016·2016-09-14

    Innovision Innocor Cardiopulmonary Testing System Recalled for Electric Shock Risk

    Innovision A/S is recalling eight Innocor Cardiopulmonary Exercise and Lung Function Testing Systems to replace USB cables that lack galvanic isolation, preventing potential electric shock.

    Product
    Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2730-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms or therapy interruption.

    Product
    Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are sel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2079-2016·2016-09-14

    Lysander's Premium Teriyaki Marinade Recalled for Undeclared Allergens

    Geneva Foods is recalling Lysander's Premium Teriyaki Marinade because it contains undeclared soy, wheat, and sulfites.

    Product
    Lysander's Premium Teriyaki Marinade, 1 oz (28 g), polypropylene and clamshell style card, 12 units per case. Manufactured by Geneva Foods, LLC.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2068-2016·2016-09-14

    Nature Made Gummy Multivitamin Recalled for Possible Salmonella Contamination

    Pharmavite is recalling specific lots of Nature Made adult gummy multivitamins due to possible Salmonella contamination. Consumers should check their lot numbers and expiration dates.

    Product
    Nature Made(R) adult gummies Multi for Her plus Omega-3, 100 count, UPC 0-31604-04236-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2071-2016·2016-09-14

    Nature Made Super B-Complex Recalled for Possible Bacterial Contamination

    Pharmavite is recalling Nature Made Super B-Complex vitamins due to possible Staphylococcus aureus and Salmonella contamination in specific lots.

    Product
    Nature Made(R) Super B-Complex, KEY B VITAMINS + VITAMIN C, 460 count, UPC 0-31604-02728-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2086-2016·2016-09-14

    Archer Farms Quinoa Recalled for Undeclared Wheat Allergen

    Superior Foods is recalling Archer Farms Quinoa 10 oz bags due to undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Archer Farms Quinoa 10 oz packaged in flexible plastic bag
    Category
    Food
    Distribution
    7 states

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