The Recall Desk

Archive

October 2014 recalls

501 recalls were announced in October 2014.

What the numbers show

Critical
33
Severe
108
High
200
Moderate
147
Low
13

Of the 501 recalls this month scored against our rubric, 7% are Critical, 22% are Severe.

401–500 of 501

  • HighNHTSA·14V617000·2014-10-03

    Ford E-250 and E-350 Wheelchair Lift Platform Recall

    New England Wheels is recalling 2006-2014 Ford E-250 and E-350 vans with specific Ricon wheelchair lifts because the platform side plate may crack.

    Product
    FORD — FORD E-350, E-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·064-2014·2014-10-02

    Olson Meat Recalls Pork Blood Product Produced Without Federal Inspection

    Olson Meat is recalling 160 pounds of pork blood product produced without federal inspection. The product was shipped to a single retailer in Hawaii.

    Product
    Olson Meat Plant — California Firm Recalls Pork Blood Product Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighCPSC·15001·2014-10-02

    Zazou Women's Silk Scarves Recalled for Burn Hazard

    Zazou Scarves is recalling about 3,800 women's silk scarves because they fail to meet federal flammability standards, posing a risk of burn injury.

    Product
    Zazou women's silk scarves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15002·2014-10-02

    Toys R Us Recalls Koala Children's Sandals Due to Choking Hazard

    Toys R Us is recalling Koala children's sandals because the butterfly wings can detach, posing a choking hazard to young children.

    Product
    Koala children's sandals with butterfly wings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2520-2014·2014-10-01

    Silva Dehydrated Minced Green Onion Recalled for Salmonella Contamination

    Silva International is recalling dehydrated minced green onion due to reported Salmonella contamination. The product was distributed in Wisconsin.

    Product
    Dehydrated minced green onion sold under the Silva brand and packaged in 28 lb. box.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2517-2014·2014-10-01

    Boku Super Food 3.0 Recalled Due to Salmonella Contamination Risk

    BoKU International is recalling 10 oz. Boku Super Food 3.0 because it may be contaminated with Salmonella. The product was sold online directly to customers.

    Product
    Boku Super Food 3.0, Product Sizes: 10 oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2515-2014·2014-10-01

    Boku Super Protein 3.0 Recalled for Potential Salmonella Contamination

    BoKU International is recalling Boku Super Protein 3.0 because it may be contaminated with Salmonella. The product was sold online directly to customers.

    Product
    Boku Super Protein 3.0, Product Sizes: 21.2 oz, 1 oz., bulk.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2518-2014·2014-10-01

    Garden Fresh Egg Salad Recalled for Potential Listeria Contamination

    Garden-Fresh Foods, Inc. is recalling Garden Fresh Egg Salad due to potential Listeria monocytogenes contamination. The product was distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Garden Fresh Egg Salad, Code #2022, Net Wt. 5 lbs. (2.268 Kg) UPC 11596-52022
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-2516-2014·2014-10-01

    Boku Super Food 2.0 Recalled for Potential Salmonella Contamination

    BoKU International is recalling Boku Super Food 2.0 (28.2 oz) because it may be contaminated with Salmonella. The product was sold online directly to customers.

    Product
    Boku Super Food 2.0, Product Sizes: 28.2 oz
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2490-2014·2014-10-01

    Oriya Organics Superfood Protein Medley Recalled for Salmonella Contamination

    Oriya Organics is recalling its Superfood Protein Medley because the product may be contaminated with Salmonella. The product was sold in Texas, Louisiana, and online to consumers in five states.

    Product
    Oriya organics Superfood Protein Medley Sprouted Chia Seeds Spirulina Sprouted Brown Rice Protein Hemp Protein Chlorella in NET WT. 21.2 OZ. (600 g) white poly bottles USDA ORGANIC
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2685-2014·2014-10-01

    Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors

    Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from indiv
    Category
    Medical Device
    Distribution
    25 states
  • SevereFDA (Devices)·Z-2695-2014·2014-10-01

    PDG Fuze Manual Tilt Wheelchairs Recalled for Axle Plate Detachment Risk

    PDG Product Design Group is recalling Fuze T50, T20, and T50 Jr manual tilt wheelchairs because a hex bolt head might shear, causing the axle plate to detach and the wheels to collapse.

    Product
    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-2622-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues

    ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.

    Product
    98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1606-2014·2014-10-01

    Baxter Recalls Potassium Chloride Bags Due to Mispackaging Error

    Baxter Healthcare is recalling 148,632 bags of Potassium Chloride Injection because shipping cartons were incorrectly labeled and contained Gentamicin Sulfate Injection instead.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2702-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leaks

    Vapotherm is recalling 387 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2014·2014-10-01

    Spacelabs Patient Monitor Recall for Missing Audible Alarms in End Case Mode

    Spacelabs Healthcare is recalling 222 patient monitors because they may fail to provide audible alarms in End Case mode, a defect missed in a previous recall.

    Product
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2505-2014·2014-10-01

    Sebastian Supreme Crab Meat Recalled for Potential Botulism Risk

    Supreme Distributors is recalling Sebastian Supreme brand crab meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Sebastian Supreme brand Super Lump Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V615000·2014-10-01

    Entegra Aspire and Anthem Motorhomes Recalled for Fuel Filter Defect

    Entegra is recalling 2015 Aspire and Anthem motorhomes because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    ENTEGRA — ENTEGRA ASPIRE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2519-2014·2014-10-01

    La Orocovena Pound Cake Queso Recalled for Undeclared Allergens

    La Orocovena Biscuit is recalling Pound Cake Queso products due to undeclared milk, wheat, soy, and color additives.

    Product
    La Orocovena, Pound Cake Queso, NET WT. 2 OZ. (56.7 grams)
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2507-2014·2014-10-01

    Supreme Choice Pasteurized Crab Meat Recalled for Botulism Risk

    Supreme Distributors, Inc. is recalling Supreme Choice brand Premium Pasteurized Crab Meat due to a potential hazard of Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Special, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V614000·2014-10-01

    GM Recalls 2013-2014 Vehicles for Chassis Electronic Module Electrical Short Risk

    General Motors is recalling 106,307 vehicles from 2013-2014 because a contaminated chassis electronic module may cause an electrical short, leading to stalling and increased crash risk.

    Product
    CHEVROLET — CHEVROLET, BUICK, GMC IMPALA, ENCLAVE, ACADIA, CTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during attachment or manipulation.

    Product
    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2620-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2014·2014-10-01

    CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

    CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

    Product
    CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2619-2014·2014-10-01

    ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate

    ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

    Product
    STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2696-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheters Recalled for Luer Cracking Risk

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during use.

    Product
    UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2014·2014-10-01

    Siemens Artis zee and zeego X-ray Systems Recalled for Radiation Release Issue

    Siemens is recalling 206 Artis zee and Artis zeego X-ray systems because radiation release can become blocked unnecessarily under certain circumstances.

    Product
    Artis zee and Artis zeego systems. x-ray, angiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2699-2014·2014-10-01

    Vapotherm Precision Flow Patient Circuits Recalled for Water Leakage

    Vapotherm, Inc. is recalling 22,828 Precision Flow Disposable Patient Circuits because they may allow water to leak into the gas lumen.

    Product
    Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2678-2014·2014-10-01

    Philips CT Scanner Recall Due to Inaccurate Extended Display Reconstruction

    Philips Medical Systems is recalling 61 CT scanners because the Extended Display Field of View reconstruction feature produces inaccurate CT numbers and anatomy.

    Product
    No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-2499-2014·2014-10-01

    Roots Lima Bean Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Lima Bean Hummus because the label lists Tamari but fails to state 'Contains Soy.'

    Product
    Roots, Lima Bean Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2691-2014·2014-10-01

    Justright Surgical Recalls 5mm Reloads Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Reloads because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firing is required during a surgery.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2676-2014·2014-10-01

    Peters Surgical Recalls CARDIOFLON Evolution Sutures for Surface Splitting

    Peters Surgical is recalling 22,190 units of CARDIOFLON Evolution sutures due to a potential splitting of the surface treatment on thread ends.

    Product
    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2674-2014·2014-10-01

    DePuy Synthes Recalls TI Vectra Plates Due to Missing Clips

    Synthes, Inc. is voluntarily recalling 16 units of TI Vectra Plates because clips may be missing. The plates are used for cervical spine fixation.

    Product
    DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.257 lot 3693878 TI Vectra" Plate 4 Level / 64 mm part 04.613.364 lot 8143905
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-2675-2014·2014-10-01

    Peters Surgical Recalls CARDIOXYL Sutures Due to Surface Treatment Splitting

    Peters Surgical is recalling 4,976 units of CARDIOXYL synthetic surgical sutures because a potential splitting of the surface treatment on thread ends was identified.

    Product
    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and whit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2491-2014·2014-10-01

    4C HomeStyle Parmesan Grated Cheese Recalled for Salmonella Contamination

    4C Foods Corp. is recalling 4C HomeStyle Parmesan Grated Cheese due to Salmonella contamination. The product was distributed in eight states.

    Product
    4C GRATED CHEESE HOMESTYLE 100% NATURAL PARMESAN, NET WT. 6 OZ. (170g) glass jars, UPC Number:0-41387-32790-8. Manufactured by 4C FOOD CORP., BROOKLYN, NY 11208. Product of USA.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2511-2014·2014-10-01

    Supreme Choice Crab Meat Recalled for Potential Botulism Risk

    Supreme Distributors is recalling Supreme Choice brand crab meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Colossal, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2510-2014·2014-10-01

    Supreme Choice Jumbo Lump Crab Meat Recalled for Botulism Risk

    Supreme Choice Jumbo Lump Crab Meat is being recalled due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Jumbo Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2498-2014·2014-10-01

    Roots Spinach Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Spinach Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Spinach Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 860971000047, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2496-2014·2014-10-01

    Roots Hot Chipotle Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Hot Chipotle Hummus because the label lists Tamari but fails to state 'Contains Soy.'

    Product
    Roots, Hot Chipotle Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000054, and 723175787612, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2508-2014·2014-10-01

    Supreme Choice Backfin Crab Meat Recalled for Botulism Risk

    Supreme Choice brand Backfin crab meat is being recalled due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Backfin, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2709-2014·2014-10-01

    Philips Brilliance CT System Recalled for Finger Squeeze Hazard

    Philips is recalling 364 Brilliance CT systems due to a gap in the tilt stand covers that can squeeze fingers during gantry movement.

    Product
    Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as single unit. Computed tomography scanner intended to provide cross sectional images of the human body and visualization of the internal organs.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2690-2014·2014-10-01

    Justright Surgical Recalls 5mm Staplers Due to Poor Staple Formation

    Justright Surgical is recalling specific lots of JustRight 5mm Staplers because they may deliver poor distal staple formation past the end of the knife cut.

    Product
    Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2621-2014·2014-10-01

    ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk

    ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.

    Product
    83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 865 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2706-2014·2014-10-01

    Vapotherm Precision Flow Patient Circuit Recalled for Potential Water Leakage

    Vapotherm, Inc. is recalling 207 units of Precision Flow Disposable Patient Circuits because water may leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Thera
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2703-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm is recalling 22,042 Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 635 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult pati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2522-2014·2014-10-01

    Southern Home Mozzarella Sticks Recalled for Wheat Allergen Mislabeling

    Great American Appetizers is recalling Southern Home Mozzarella Sticks because the ingredient list includes wheat, but the 'Contains' statement omits it.

    Product
    Product is packaged in a cardboard box and labeled in part, "SOUTHERN HOME Mozzarella Sticks***CONTAINS: WHEY, MILK, EGG, SOY***DISTRIBUTED BY SOUTHERN HOME P.O.BOX 99 MAULDIN, SC 29662***" 6/case 30oz UPC 607880027150
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2494-2014·2014-10-01

    Roots Thai Coconut Curry Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Thai Coconut Curry Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Thai Coconut Curry Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000092, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2670-2014·2014-10-01

    Centurion Medical Products Recalls Saline Flush Syringes Due to Open Seals

    Centurion Medical Products is recalling 21,388 saline flush syringes used in convenience kits because open seals may compromise package integrity and sterility.

    Product
    0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits. Recalled product is attached to the outside of the Convenience Kits.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2704-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recall for Water Leakage

    Vapotherm, Inc. is recalling 360 units of Precision Flow Disposable Patient Circuits because they allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged with compatible cannulas for evaluation of the Precision Flow system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2014·2014-10-01

    Genesys Spine Recalls Circular Lock Screws Due to Material Error

    Genesys Orthopedics Systems is recalling 642 Circular Lock Screws from the TiLock Pedicle Screw System because a portion of the lot was manufactured with stainless steel instead of the specified titanium alloy.

    Product
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2504-2014·2014-10-01

    Supreme Brand Special Crab Meat Recalled for Botulism Risk

    Supreme Distributors is recalling 16 oz cans of Special Crab Meat due to a potential risk of Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme brand Special Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2497-2014·2014-10-01

    Roots Black Bean Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Black Bean Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Black Bean Hummus, Net Wt. 8oz (227 g), and 16 oz. (454 g), Gluten-Free Vegan, UPC: 860971000030, and 723175787636, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2500-2014·2014-10-01

    Roots Organic Gourmet Recalls Oil Free Original Hummus for Missing Soy Labeling

    Roots Organic Gourmet is recalling Oil Free Original Hummus because the label lists Tamari but fails to state 'Contains Soy.'

    Product
    Roots, Oil Free Original Hummus, Net Wt. 8 oz (227 g), Gluten-Free Vegan, UPC: 723175787599, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com.This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2493-2014·2014-10-01

    Roots Roasted Garlic Hummus Recalled for Missing Soy Allergen Labeling

    Roots Organic Gourmet is recalling Roasted Garlic Hummus because the label lists Tamari but lacks a 'Contains Soy' statement.

    Product
    Roots, Roasted Garlic Hummus, Net Wt. 8oz (227 g), Gluten-Free Vegan, UPC: 860971000016, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2700-2014·2014-10-01

    Vapotherm Precision Flow Disposable Patient Circuit Recalled for Water Leakage

    Vapotherm, Inc. is recalling 1,005 units of Precision Flow Disposable Patient Circuits because they may allow water to leak into the center gas lumen.

    Product
    Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2694-2014·2014-10-01

    Alcon Recalls Eye-Pak 7407 Tray Support Covers Due to Seal Issues

    Alcon Research, Ltd. is recalling 2,462 Eye-Pak 7407 Tray Support Covers because insufficiently sealed peel pouches may compromise sterility.

    Product
    eye-pak 7407 Tray Support Cover REF 8065740745
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2014·2014-10-01

    ArjoHuntleigh Recalls Minstrel Mobile Passive Hoists Due to Bolt Failure

    ArjoHuntleigh is recalling 18 Minstrel mobile passive hoists because a bolt under the scale may unscrew, posing a risk of the spreader bar detaching during use.

    Product
    Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to saf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2697-2014·2014-10-01

    Argon UltraStream Hemodialysis Catheter Recall Due to Luer Cracking

    Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because the red arterial luer may crack during attachment or manipulation.

    Product
    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V612000·2014-10-01

    Coach and Equipment Recalls Transit Buses with Cracking Wheelchair Lifts

    Coach and Equipment is recalling 2006-2014 transit buses equipped with certain Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT CONDOR LT, PHOENIX, ALLEY CAT, PEGASUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2014·2014-10-01

    Ortho-Clinical Diagnostics Recalls VITROS Anti-HCV Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Anti-HCV Reagent Packs due to signal loss that may cause false negative test results for hepatitis C.

    Product
    VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagen
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-2506-2014·2014-10-01

    Supreme Choice Crab Meat Recalled for Potential Botulism Risk

    Supreme Distributors, Inc. is recalling Supreme Choice brand Premium Pasteurized Crab Meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Claw , 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2689-2014·2014-10-01

    CareFusion AirLife Heated Infant Breathing Circuit Recalled for Material Change

    CareFusion is recalling approximately 318,280 heated infant breathing circuits due to a regulatory compliance risk involving a material change to the gas pathway.

    Product
    CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2014·2014-10-01

    Siemens AXIOM Artis and Artis zee Systems Recalled for X-Ray Release Issue

    Siemens is recalling AXIOM Artis and Artis zee angiography systems because a hand switch defect may cause uncontrolled x-ray release.

    Product
    AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2501-2014·2014-10-01

    Blue Diamond Nut-Thins Recalled for Gluten Contamination

    Blue Diamond Growers is recalling Artisan Nut-Thins because gluten protein was detected in a product labeled gluten-free.

    Product
    Natural Blue Diamond Almonds Artisan Nut-Thins crafted with brown rice, almonds & Chia Seeds Wheat & Gluten free Net wt. 4.25 oz. Box. (120.5g) Cracker Snacks UPC: 41570 10938 Best Before Dates: AUG 06 15 and AUG 07 15 Manufactured for: Blue Diamond Growers 1802 C St.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2509-2014·2014-10-01

    Supreme Choice Crab Meat Recalled for Potential Botulism Risk

    Supreme Distributors, Inc. is recalling Supreme Choice brand crab meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme Choice brand Super Lump, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2492-2014·2014-10-01

    Roots Organic Gourmet Recalls Original Hummus Due to Missing Soy Labeling

    Roots Organic Gourmet is recalling Original Hummus because the label fails to state 'Contains Soy' despite listing Tamari as an ingredient.

    Product
    Roots, Original Hummus, Net Wt. 8oz (227 g), and 16oz (454 g), Gluten-Free Vegan, UPC: 860971000009, and 723175787629, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2503-2014·2014-10-01

    Supreme Colossal Crab Meat Recalled for Potential Botulism Risk

    Supreme Distributors is recalling 16 oz cans of Colossal Crab Meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Supreme brand Colossal Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2495-2014·2014-10-01

    Roots Roasted Red Bell Pepper Hummus Recalled for Missing Soy Labeling

    Roots Organic Gourmet is recalling Roasted Red Bell Pepper Hummus because the label fails to state 'Contains Soy' despite listing Tamari as an ingredient.

    Product
    Roots, Roasted Red Bell Pepper Hummus, Net Wt. 8oz (227 g), and 16oz. (454 g), Gluten-Free Vegan, UPC: 860971000023, and 723175787605, 166 W. Haywood St., Asheville, NC 2801, RootsFood.com. This product is packaged in 8 oz. and 16 oz. non-flexible plastic tubs.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2512-2014·2014-10-01

    Blue Star Claw Crab Meat Recalled for Botulism Risk

    Supreme Distributors is recalling Blue Star Claw Crab Meat due to potential Clostridium botulinum toxin formation from temperature abuse.

    Product
    Blue Star Claw Crab Meat, 16 oz; Premium Pasteurized Crab Meat. Product of Thailand. Distributed by Supreme Lobster and Seafood Company, Villa Park, IL 60181
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2672-2014·2014-10-01

    Vidacare EZ-IO Needle Set Recalled for Specification Failures

    Vidacare Corporation is voluntarily recalling 172 units of EZ-IO 45mm Needle Sets because they do not meet specifications.

    Product
    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2502-2014·2014-10-01

    Phoenix Produce Recalls Chinese Style Noodles for Undeclared Dyes

    Phoenix Produce & Noodle Company is recalling Chinese Style Noodles in Arizona because they contain undeclared FD&C Yellow No. 5, Yellow No. 6, and Red No. 40.

    Product
    Chinese Style Noodles, 10lbs./bx
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2687-2014·2014-10-01

    Beckman Coulter Recalls Sample Probe Cables for Immunoassay Systems

    Beckman Coulter is recalling sample probe cables for UniCel immunoassay systems because nonconforming units may cause delays in reporting test results.

    Product
    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2514-2014·2014-10-01

    Arise & Shine Bentonite Supplement Recalled for Iron Mislabeling

    Arise & Shine is recalling Hydrated Bentonite dietary supplements because the label incorrectly states 0% Daily Value of iron, while the product actually contains 106%.

    Product
    The product is labeled in part "***Arise & Shine Hydrated Bentonite Dietary Supplement Extra Thick Formula 32 FL OZ ***% Daily Value Iron 0***Distributed by: Arise & Shine Herbal Products 562 Parsons Drive Medford, Oregon 97501***" Product is packaged in a foil pouch with a plas
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2684-2014·2014-10-01

    Nanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors

    Nanosphere is recalling Verigene Respiratory Virus Plus tests because Tip Holder Assemblies caused increased processing errors on the Processor SP.

    Product
    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with sign
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Food)·F-2487-2014·2014-10-01

    Dairy Farmers of America Recalls Raw Milk for Sulfamethazine

    Dairy Farmers of America is recalling raw milk that tested positive for the antibiotic sulfamethazine. The milk was distributed to processors in Ohio, Illinois, Missouri, and Michigan.

    Product
    Raw Milk (Bulk; approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2692-2014·2014-10-01

    Horiba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update

    Horiba Medical is recalling ABX PENTRA Magnesium RTU Reagent to update on-board stability claims from 7 days to 1 day.

    Product
    ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1605-2014·2014-10-01

    Qualitest Recalls Subpotent Methylprednisolone Tablets Due to Stability Issues

    Qualitest Pharmaceuticals is recalling specific lots of Methylprednisolone 4 mg tablets because they may be subpotent due to a 6-month stability time point issue.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2485-2014·2014-10-01

    Dairy Farmers of America Recalls Condensed Skim Milk for Sulfamethazine

    Dairy Farmers of America is recalling condensed skim milk because raw milk tested positive for the antibiotic sulfamethazine. The product was distributed to facilities in Ohio, Illinois, Missouri, and Michigan.

    Product
    Condensed Skim Milk in bulk tanker (approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2679-2014·2014-10-01

    Instratek Recalls Mini Screw Sets with Faded Markings

    Instratek is recalling 96 Mini Screw Sets and gauges due to faded and incorrect markings on instruments.

    Product
    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2688-2014·2014-10-01

    Smith & Nephew Recalls RENASYS EZ Negative Pressure Wound Therapy Systems

    Smith & Nephew is recalling RENASYS EZ Negative Pressure Wound Therapy Systems because modifications were made without required FDA notifications.

    Product
    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2488-2014·2014-10-01

    Lakewood Organic Apple Juice Recalled for Inorganic Arsenic Levels

    Florida Bottling, Inc. is recalling Lakewood Organic Apple Juice because it contains inorganic arsenic levels exceeding FDA limits of concern.

    Product
    Lakewood Organic Fresh Pressed GMO Free Pure Apple Cold Pressed Not from Concentrate Juice Fruit 32 FL OZ (1 QT) 946 mL Lakewood Miami, FL 33127
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-2486-2014·2014-10-01

    Dairy Farmers of America Recalls Bulk Cream Due to Sulfamethazine

    Dairy Farmers of America is recalling bulk cream after raw milk tested positive for the drug Sulfamethazine. The product was distributed to facilities in Ohio, Illinois, Missouri, and Michigan.

    Product
    Cream (Bulk; approximately 40,000 pounds per tanker load)
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2708-2014·2014-10-01

    Dako Autostainer Link 48 Software Recall for Reagent Handling Issues

    Dako is recalling software for the Autostainer Link 48 because an upgrade may cause premature reagent rejection or inadequate aspiration if specific maintenance conditions are met.

    Product
    Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2682-2014·2014-10-01

    Nanosphere Recalls Verigene Clostridium difficile Test Due to Processing Errors

    Nanosphere is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.

    Product
    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PC
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2673-2014·2014-10-01

    Becton Dickinson Recalls BD PosiFlush SF Saline Flush Syringes Due to Open Seals

    Becton Dickinson is recalling 3,088,320 units of BD PosiFlush SF Saline Flush Syringes because some units were found with open seals.

    Product
    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1604-2014·2014-10-01

    Hospira Recalls Buprenorphine Hydrochloride Injection Due to Impurity Failure

    Hospira Inc. is recalling specific lots of Buprenorphine Hydrochloride Injection because the product failed impurity specifications during stability testing.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2683-2014·2014-10-01

    Nanosphere Recalls Verigene Gram-Positive Blood Culture Test Due to Processing Errors

    Nanosphere is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test because Tip Holder Assemblies caused increased processing errors.

    Product
    The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-2686-2014·2014-10-01

    Fresenius Naturalyte Liquid Bicarbonate Concentrate Recalled for Temperature Violation

    Fresenius Medical Care is recalling 72 cases of Naturalyte Liquid Bicarbonate Concentrate distributed in Texas because the product was held at temperatures above the recommended storage range.

    Product
    Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2513-2014·2014-10-01

    Frito-Lay Recalls Oven Baked Lay's BBQ Crisps Due to Packaging Error

    Frito-Lay is recalling Oven Baked Lay's BBQ flavor crisps because a packaging error added a 'GF' symbol to the packages.

    Product
    Oven Baked Lay's BBQ flavor crisps in 1 1/8 oz package, UPC 2840007189
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2680-2014·2014-10-01

    Siemens Ysio Systems Recalled for Potential Image Artifacts

    Siemens is recalling 62 Ysio Systems due to a software error that may cause line artifacts in images, potentially requiring examinations to be repeated.

    Product
    The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1571-2014·2014-10-01

    Akorn Recalls Rifampin for Injection Due to Impurity Specification Failure

    Akorn, Inc. is recalling 5,539 vials of Rifampin for Injection USP, 600 mg, because a stability test showed an impurity level exceeding specifications.

    Product
    Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1608-2014·2014-10-01

    Noven Recalls Daytrana Patches Due to Defective Delivery System

    Noven Pharmaceuticals is recalling 160,800 Daytrana patches because the adhesive release liner may be difficult to remove.

    Product
    DAYTRANA — DAYTRANA (METHYLPHENIDATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2521-2014·2014-10-01

    Purple Corn Drink Recalled for Undeclared Dyes and Unallowable Colorant

    JP Trading and Global Imports LLC is recalling 85 cases of Tradiciones' Andinas Purple Corn Drink Chicha Morada due to undeclared dyes and an unallowable colorant.

    Product
    Tradiciones' Andinas Purple Corn Drink Chicha Morada, Net Wt: 33,81 Fl. oz. (1 Lt.), Distributed by: JP Trading and Global Imports LLc, Newark, NJ 07102 (973) 242-3143, Toll free (888) 606 PERU, NDC 854219002795
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1607-2014·2014-10-01

    Alvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure

    Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg because the lot failed uniformity of dosage units specifications for the oxycodone component.

    Product
    Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2681-2014·2014-10-01

    Nanosphere Recalls Verigene Gram Negative Blood Culture Test Kits

    Nanosphere is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test due to an increased rate of processing errors caused by tip holder assemblies.

    Product
    The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance mark
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Drugs)·D-1609-2014·2014-10-01

    Apotex Recalls Olanzapine Tablets Due to Subpotent Drug Levels

    Apotex Corp. is recalling Olanzapine Orally Disintegrating Tablets 5 mg because testing showed the drug levels were below specification.

    Product
    Olanzapine Orally Disintegrating Tablets 5 mg, 30-count Bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada M9L1T9, Manufactured for Apotex Corp., Weston, Florida 33326, NDC # 60505-3275-03
    Category
    Drug
    Distribution
    Distributed nationwide

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