The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
165
High
268
Moderate
204
Low
33

Of the 688 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

Which agencies issued them

101–200 of 688

  • ModerateFDA (Devices)·Z-2101-2014·2014-07-30

    Terumo Recalls Sarns Venoatrial Cannulae Due to Loose Fiber Particulate

    Terumo CVS is recalling 3,040 Sarns Venoatrial Cannulae units because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1450-2014·2014-07-30

    Shamrock Recalls Mislabelled Sulfamethoxazole and Trimethoprim Tablets

    Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim tablets due to a labeling error where 800 mg/160 mg tablets were labeled as 400 mg/80 mg.

    Product
    SULFAMETHOXAZOLE AND TRIMETHOPRIM — SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2113-2014·2014-07-30

    Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval

    Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.

    Product
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2103-2014·2014-07-30

    Terumo TenderFlow Pediatric Venous Cannulae Recalled for Loose Fiber Particulate

    Terumo CVS is recalling specific lots of TenderFlow Pediatric Venous Cannulae due to loose fiber particulate exceeding specifications found during inspection.

    Product
    Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2220-2014·2014-07-30

    Land O'Lakes Recalls Yellow Process Cheese Due to Plastic Contamination

    Land O'Lakes is recalling specific lots of yellow process cheese due to potential contamination with large pieces of plastic.

    Product
    Item: 48770 Land O'Lakes, Pasteurized Process Cheese Product, Yellow, NET WT 5 LBS (2.27 KG).
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-2209-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Temperature Storage Violations

    Kraft Foods is voluntarily recalling multiple brands of cottage cheese because ingredients were not stored at proper temperatures, creating a potential safety risk.

    Product
    Cottage cheese, 4% milkfat, sold under the Daily Chef, Knudsen, or Kraft brand and packaged in a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2208-2014·2014-07-30

    Kraft Recalls Cottage Cheese Due to Improper Ingredient Storage

    Kraft Foods is voluntarily recalling cottage cheese sold under Breakstone's, Daily Chef, Knudsen, and Kraft brands because ingredients were not stored at proper temperatures.

    Product
    Low fat cottage cheese, 2% milkfat, sold under the Breakstone's brand, Daily Chef brand, Knudsen brand, or Kraft brand packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g), a tray of 8 plastic containers each with a net weight of 4 oz. (113 g), a…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2214-2014·2014-07-30

    Kraft Recalls Knudsen and Other Cottage Cheese Due to Temperature Storage Issues

    Kraft Foods is voluntarily recalling multiple cottage cheese brands produced in Tulare, CA, because ingredients were not stored at proper temperatures.

    Product
    Cottage Doubles - cottage cheese, 2% milkfat, with raspberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1451-2014·2014-07-30

    Shamrock Medical Recalls Docusate Calcium Softgels Due to Labeling Error

    Shamrock Medical Solutions is recalling Docusate Calcium Softgel Capsules because they were mislabeled as Docusate Sodium. The error involves a label mix-up for the specific active ingredient.

    Product
    Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-1444-2014·2014-07-30

    X-Gen Recalls Clonidine HCl Injection Due to Labeling Error

    X-Gen Pharmaceuticals is recalling Clonidine HCl Injection vials because the side label incorrectly states the drug strength.

    Product
    CLONIDINE — CLONIDINE (CLONIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2200-2014·2014-07-30

    Dolci Gelati Recalls YES Green Tea Gelato for Organic Mislabeling

    Dolci Gelati LLC is recalling YES Green Tea Gelato because it was mislabeled as organic. The product was sold exclusively at Yes Organic Market in the MD/DC area.

    Product
    YES Green Tea Gelato
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-2090-2014·2014-07-30

    Zoll Circulation Recalls AutoPulse Accessories Due to Japanese Label Typo

    Zoll Circulation is recalling 161 NiMH batteries and 40 LifeBand packs distributed in Japan due to a typographical error on the Japanese legal label.

    Product
    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1445-2014·2014-07-30

    Sandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures

    Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets because they failed dissolution specifications during stability testing.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1452-2014·2014-07-30

    Estee Lauder Recalls DENBLAN Toothpaste Due to Stability Data Issues

    Estee Lauder Inc is recalling 3,791 tubes of DENBLAN Anticavity Fluoride Toothpaste because stability data does not support the product's expiry date.

    Product
    DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2201-2014·2014-07-30

    Dolci Gelati Recalls Sea Salt Caramel Gelato for Organic Mislabeling

    Dolci Gelati LLC is recalling YES Sea Salt Caramel Gelato because it was mislabeled as organic. The product was sold exclusively at Yes Organic Market in the MD/DC area.

    Product
    YES Sea Salt Caramel Gelato
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14E051000·2014-07-29

    Cummins Fleetguard Fuel Filter Recall for Engine Stalling Risk

    Cummins is recalling specific Fleetguard UFF-XT fuel filters installed on ISB and ISL engines because the filter shell may separate, causing the engine to stall without warning and increasing crash risk.

    Product
    FUEL SYSTEM, DIESEL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V460000·2014-07-29

    GM Recalls 2009-2010 Chevrolet Aveo and Pontiac G3 for Brake Defect

    General Motors is recalling 2009-2010 Chevrolet Aveo and 2009 Pontiac G3 vehicles because brake fluid may corrode ABS valves, potentially reducing braking performance.

    Product
    CHEVROLET — CHEVROLET, PONTIAC AVEO, G3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E050000·2014-07-29

    Dana Commercial Vehicle Driveshaft Recall for Welded Bond Failure

    Dana is recalling commercial vehicle lightweight driveshafts where the welded bond may fail, potentially causing loss of torque to the rear wheels.

    Product
    POWER TRAIN:DRIVELINE:DRIVESHAFT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14242·2014-07-29

    Philips Recalls Lightolier Glass Lenses Due to Laceration Hazard

    Philips Lighting is recalling Lightolier AF4SY decorative glass lenses because they can shatter and cause cuts. Consumers should remove the lenses and contact Philips for a free replacement.

    Product
    Philips "Lightolier" brand AF4SY Decorative Glass Lens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V457000·2014-07-28

    Porsche Recalls 2015 918 Spyder for Rear Axle Control Arm Defect

    Porsche is recalling 2015 918 Spyder vehicles because rear-axle control arms may break, potentially causing loss of vehicle control and increasing crash risk.

    Product
    PORSCHE — PORSCHE 918 SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V459000·2014-07-28

    Gillig Recalls 2013-2014 Low Floor Buses for Brake Valve Defect

    Gillig is recalling 252 Low Floor transit buses from 2013-2014 because they may lack a rear brake quick release valve, potentially causing rear wheel lockup.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E049000·2014-07-28

    Delphi Recalls Fuel Pump Modules for 2005-2010 Honda Odyssey Vehicles

    Delphi is recalling replacement fuel pump modules for 2005-2010 Honda Odysseys that may display incorrect fuel levels, increasing the risk of stalling and crashes.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·049-2014·2014-07-26

    Puritan Foods Recalls Raw Turkey Breasts for Undeclared Milk Allergen

    Puritan Foods Co. is recalling raw boneless turkey breasts because the product contains milk, a known allergen, that is not declared on the label.

    Product
    Puritan Foods Co., Inc. — Massachusetts Firm Recalls Raw Boneless Turkey Breasts Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V492000·2014-07-25

    Wilson Trailer Company Recalls 2014-2015 Grain and Livestock Trailers

    Wilson Trailer Company is recalling 2014-2015 Grain and Livestock trailers due to a defect in pivot bolts that could cause the suspension to separate.

    Product
    WILSON — WILSON LIVESTOCK TRAILER, GRAIN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V455000·2014-07-25

    KME Fire Fighting Vehicles Recalled for Seat Belt Latch Defect

    Kovatch is recalling 2013-2014 KME Panther and Predator fire fighting vehicles because seat belt buckles may fail to release, hindering emergency egress.

    Product
    KME — KME PANTHER, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-072514·2014-07-25

    Processed Breaded Chicken Products Produced Without Inspection

    USDA FSIS issued a public health alert for breaded chicken products from VU Foods, LLC, produced without inspection and deemed unfit for human consumption.

    Product
    FSIS Issues Public Health Alert for Processed Breaded Chicken Products Produced Without the Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·14E048000·2014-07-25

    Triangle Warning Signs Recalled for Inadequate Light Reflection

    W.W. Grainger is recalling triangle warning signs that may not reflect enough light, potentially failing to warn other drivers of parked vehicles.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·048-2014·2014-07-24

    Great American Marketing Recalls Ready-to-Eat Sandwiches for Listeria Risk

    Great American Marketing is recalling approximately 475 pounds of ready-to-eat sandwiches and wraps due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Great American Marketing Co. — Texas Firm Recalls Ready-To-Eat Products for Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14E046000·2014-07-24

    SKF Recalls Axle Seals for Chevrolet and GMC Vehicles

    SKF is recalling axle seals for 1999-2013 Chevrolet and GMC vehicles because leaking gear oil can contaminate brakes and increase crash risk.

    Product
    POWER TRAIN:AXLE ASSEMBLY:AXLE SHAFT:SEAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V453000·2014-07-24

    Godwin Recalls Modified Ford Super Duty Trucks Due to Fire Risk

    Godwin is recalling certain modified Ford Super Duty trucks because oil from a PTO pressure switch may leak onto the exhaust, increasing fire risk.

    Product
    FORD — FORD F-550 SD, F-450 SD, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14241·2014-07-24

    Metabo Recalls Electric Angle Grinders Due to Laceration Hazard

    Metabo is recalling about 4,300 Ergo series 6-inch angle grinders because the on/off switch can stick in the "On" position, posing a laceration hazard.

    Product
    Metabo Ergo series 6-inch angle grinders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2176-2014·2014-07-23

    Six Dog LLC Recalls Owl Canyon Whole Eggs Due to Salmonella Risk

    Six Dog, LLC is recalling 220 packages of Owl Canyon Whole Eggs due to potential Salmonella Enteritidis contamination. The eggs were distributed in Colorado and possibly other states.

    Product
    Certified Organic, Owl Canyon Whole Eggs, packed in one dozen and half-dozen cardstock packages, with a packing date of 93, 94, 97, or 98.
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2046-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 136 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V450000·2014-07-23

    GM Recalls 2014 Chevrolet Impala for Power Steering Loss Risk

    General Motors is recalling 2014 Chevrolet Impalas due to a poor electrical ground connection that may cause loss of power steering assist, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET IMPALA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V447000·2014-07-23

    GM Recalls 414,333 Vehicles for Power Seat Height Adjuster Bolt Defect

    General Motors is recalling 414,333 vehicles because a power seat height adjuster bolt may fall out, causing the seat to drop suddenly and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, BUICK, GMC CAMARO, REGAL, TERRAIN, EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-201·2014-07-23

    Hospira Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Hospira is recalling 47,400 vials of Fentanyl Citrate Injection because loose or missing vial crimps raise concerns about sterility.

    Product
    FENTANYL CITRATE — FENTANYL CITRATE (FENTANYL CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2173-2014·2014-07-23

    Caromont Farm Plank Road Round Cheese Recalled for Pasteurization Failure

    Caromont Farm is recalling Plank Road Round cheese because it may not have been properly pasteurized due to temperature or time errors.

    Product
    Plank Road Round (Pasteurized Cows Milk Cheese).4 oz. plastic sealed with protective band.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2058-2014·2014-07-23

    Siemens Coat-A-Count Direct Androstenedione Assay Recalled for Inaccurate Results

    Siemens Healthcare Diagnostics is recalling Coat-A-Count Direct Androstenedione assays because they show higher frequency of results greater than 10 ng/mL compared to other platforms.

    Product
    Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2195-2014·2014-07-23

    Oaxaca Mexican Products Recalls Mango Enchilado for Lead and Sulfites

    Oaxaca Mexican Products is recalling Botanos Los 3 Chavos Mango Enchilado due to undeclared colors, sulfites, and lead contamination.

    Product
    Botanos Los 3 Chavos Mango Enchilado Net Wt. 1 1/2 OZ. (42 g) Oaxaca Mexican Products 100 8th Street, Passaic, NJ 07055
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2181-2014·2014-07-23

    Pearl Valley Walnut Creek Marble Cheese Recalled for Antibiotic Residue

    Pearl Valley Cheese Inc is recalling Walnut Creek Marble Cheese because the milk used in the product tested positive for antibiotics.

    Product
    Walnut Creek Marble Cheese-- 6lbs of cheese in plastic bags; 4 per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1442-2014·2014-07-23

    CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns

    CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.

    Product
    ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V452000·2014-07-23

    Collins Recalls 2012-2014 School Buses for Propane Fuel Line Defect

    Collins Bus Corporation is recalling 374 model year 2012-2014 school buses because a propane fuel line may rub against a frame bolt, potentially causing a leak, stall, or fire.

    Product
    COLLINS — COLLINS DH516, DH516WR, DH500, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2175-2014·2014-07-23

    Vita Classic Smoked Salmon Recalled for Listeria Contamination

    Vita Food Products is voluntarily recalling 7,512 packages of sliced smoked salmon due to a positive Listeria monocytogenes test.

    Product
    Vita Classic Premium Sliced Smoked Atlantic Nova Salmon, packaged in a black vacuum-sealed, plastic film package for retail sale. Product is labeled "ready to serve" and each package contains 4 ounces of product.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2190-2014·2014-07-23

    Wegmans Cinnamon Raisin Buns Recalled for Undeclared Eggs

    Wegmans is recalling Cinnamon Raisin Buns because they contain undeclared eggs, which may be raw, posing a health risk to consumers.

    Product
    Wegmans Cinnamon Raisin Buns, NET WT. 12 OZ (340g), UPC 77890 92218 ---Baked by Wegmans Food Markets Inc. - Rochester, NY 14603
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·14V454000·2014-07-23

    Greenfield Recalls 2013-2014 Boom Dollys Due to Suspension Pivot Bolt Failure

    Greenfield is recalling specific 2013-2014 Boom Dollys because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    GREENFIELD — GREENFIELD D3 BOOM DOLLY, C3 BOOM DOLLY, B2 BOOM DOLLY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2191-2014·2014-07-23

    Nestle Recalls Häagen-Dazs Ice Cream Due to Peanut Mislabeling

    Nestle is recalling Häagen-Dazs Chocolate Chocolate Chip Ice Cream because the ingredient label fails to identify peanuts, posing a risk to consumers with peanut allergies.

    Product
    H¿agen-Dazs Chocolate Chocolate Chip Ice Cream, 14 oz, UPC of 74570-08400
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-2174-2014·2014-07-23

    Caromont Farm Recalls Pasteurized Goats Milk Cheese Due to Pasteurization Failure

    Caromont Farm is recalling specific lots of Chevre (pasteurized goats milk cheese) because the product failed to achieve proper pasteurization.

    Product
    Chevre (Pasteurized Goats Milk Cheese) Four oz. cups Fresh Chevre / Bulk Chevre - One, two, and five pound sizes
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·14V446000·2014-07-23

    GM Recalls 2013-2015 Vehicles Due to Incomplete Seat Weld

    General Motors is recalling specific 2013-2015 Buick, Cadillac, Chevrolet, and GMC vehicles because an incomplete weld may cause front seats to detach during a crash.

    Product
    CADILLAC — CADILLAC, BUICK, CHEVROLET ATS, ENCORE, SILVERADO, CTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2014·2014-07-23

    Terumo Cardiovascular Procedure Kit Recall for Pumphead Leaks

    Terumo is recalling 256 Cardiovascular Procedure Kits because leaks were detected on the centrifugal pumphead during set-up and priming of the bypass circuit.

    Product
    Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V451000·2014-07-23

    GM Recalls 2015 SUVs for Unreinforced Roof Rail Air Bags

    General Motors is recalling 2015 Chevrolet and GMC SUVs because roof rail air bags may be punctured by roof carrier hardware, increasing injury risk.

    Product
    CHEVROLET — CHEVROLET, GMC TAHOE, YUKON, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments

    Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP (Base), automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Monitor Mounts

    Stryker Communications is recalling SHAPE Arm monitor mounts because the mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE WITH GCX MOUNT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682400256…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2014·2014-07-23

    Stryker SHAPE Arm Recall for Potential Monitor Mount Detachment

    Stryker Communications is recalling 953 SHAPE Arm components because the monitor mount may detach if a lock washer and screw are missing.

    Product
    SHAPE ARM, SINGLE, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400253 and the Arm part…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2074-2014·2014-07-23

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Packaging Defects

    Baxter Healthcare is recalling 585,360 units of MiniCap with Povidone-Iodine Solution due to inadequate iodine and packaging defects.

    Product
    Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments

    Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 300 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2187-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk in Vegan Products

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars labeled as vegan or dairy-free because they contain undeclared milk.

    Product
    There are three different labels for this product. Label #1 individual bar 100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWER MINT, Gluten Free & Vegan, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1 display Carton 100% Natural…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2076-2014·2014-07-23

    Pioneer Surgical Technology Recalls Tritium Sternal Plate System Due to Sterility Concerns

    Pioneer Surgical Technology is recalling 5 units of the Tritium Sternal Plate System in Texas and Florida due to a lack of sterility assurance.

    Product
    Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2051-2014·2014-07-23

    Shape HF Cardiopulmonary System Recalled for Software Upgrade Requirement

    Shape Medical Systems is recalling 800 Shape HF Cardiopulmonary Systems because a mandatory software upgrade is required before using specific Disposable Patient Interface lots to prevent erroneous testing results.

    Product
    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2047-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach

    Smith & Nephew is recalling 907 units of SUTUREFIX Ultra S devices because a breach in the sterile barrier compromises the device's sterility.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V449000·2014-07-23

    Forest River Recalls 2013-2014 RVs with Defective Microwaves

    Forest River is recalling specific 2013-2014 recreational vehicles because the installed Frigidaire microwaves may start heating on their own, posing a fire risk.

    Product
    FOREST RIVER — FOREST RIVER SUNSEEKER, CEDAR CREEK, PATHFINDER, GEORGETOWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2014·2014-07-23

    Excelsior Medical Recalls Sterile Triple Lead Tubing Sets Due to Leak Risk

    Excelsior Medical is recalling sterile triple lead tubing sets because a molding defect may allow fluid leaks or air entry during use.

    Product
    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling specific lots of Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2186-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars because they contain undeclared milk despite being labeled as dairy-free or vegan.

    Product
    There are two different labels for this product same UPC codes. Version #1 individual bars: 100% natural Zing Complete Nutrition, CHOCOLATE COCONUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g). Version # 1 display carton: Zing Complete Nutrition, Gluten, Soy &…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-2192-2014·2014-07-23

    Schnucks Bakery Devil's Food Cake Recalled for Undeclared Pecan Allergen

    Schnucks Markets is recalling Devil's Food Cakes because the label fails to list pecan pieces, a tree nut allergen.

    Product
    Schnucks Bakery 8" Devil's Food Cake, net wt. 2 lb 13 oz, UPC: 04131831186. Also packaged as Schnucks Bakery Half Devil's Food Cake, net wt. 1 lb 7 oz plastic, UPC: 04131831078 Schnuck Markets, Inc., St. Louis, MO.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2064-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 500 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2185-2014·2014-07-23

    Zing Dark Chocolate Hazelnut Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Dark Chocolate Hazelnut bars because they contain undeclared milk despite being labeled as dairy-free or vegan.

    Product
    There are 2 different labels for this same product with the same UPC. Label #1 Individual Bars: 100% natural Zing Complete Nutrition, DARK CHOCOLATE HAZELNUT, Gluten, Soy & Dairy Free, NET WT. 1.76 OZ. (50g), Manufactured For: Zing Bars Seattle, WA 98125. Label #1…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Food)·F-2188-2014·2014-07-23

    Zing Nutrition Bars Recalled for Undeclared Milk

    NW Nutritional Foods LLC is recalling Zing Nutrition Bars labeled 'dairy free' because they contain undeclared milk.

    Product
    Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured For: Zing Bars Seattle, WA 98125. Display Carton: Zing Complete Nutrition, Gluten, Soy & Dairy Free, 100% natural CASHEW CRANBERRY…
    Category
    Food
    Distribution
    46 states
  • HighFDA (Devices)·Z-2028-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2189-2014·2014-07-23

    Betty Lou's Chocolate Dream Greens Recalled for Undeclared Milk

    Betty Lou's, Inc. is recalling Just Great Stuff Chocolate Dream Greens bars due to undeclared milk, a contaminant of the dark chocolate ingredient.

    Product
    Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The displays are shrink wrapped.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach

    Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems

    Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.

    Product
    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2014·2014-07-23

    Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment

    Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.

    Product
    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment

    Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.

    Product
    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments

    Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments

    Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 LAS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2014·2014-07-23

    Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors

    Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.

    Product
    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2049-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach

    Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.

    Product
    SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2014·2014-07-23

    Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval

    Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.

    Product
    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-2193-2014·2014-07-23

    Ducal Prepared Sauce Queso Recalled for pH Above 4.4

    Industrias Alimenticias Kern's y Cia. S.C.A. is recalling Ducal Brand Prepared Sauce Queso/Cheese because lab analysis detected a pH greater than 4.4.

    Product
    Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was…
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2178-2014·2014-07-23

    Naturex Echinacea Powder Recalled for Azoxystrobin Residue

    Naturex Inc. is recalling Echinacea powder containing Azoxystrobin, a pesticide for which no tolerance is allowed.

    Product
    Echinacea Agustifolia PE 4& echinosides The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-2177-2014·2014-07-23

    Naturex Echinacea Root Powder Recalled for Azoxystrobin Residue

    Naturex Inc. is recalling Echinacea Agustifolia Root Powder because it contains Azoxystrobin, a pesticide for which no tolerance is allowed.

    Product
    Echinacea Agustifolia Root PE 4:1 The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2043-2014·2014-07-23

    Siemens Symbia E Camera System Recalled for Loose Rear Casters

    Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.

    Product
    Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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