The Recall Desk

Archive

February 2016 recalls

511 recalls were announced in February 2016.

What the numbers show

Critical
28
Severe
159
High
175
Moderate
135
Low
14

Of the 511 recalls this month scored against our rubric, 5% are Critical, 31% are Severe.

301–400 of 511

  • SevereNHTSA·16V083000·2016-02-11

    Volkswagen Recalls 2009 Routan Vehicles Due to Air Bag Control Unit Defect

    Volkswagen is recalling 2009 Routan vehicles because the air bag control unit may corrode and fail, potentially preventing air bag deployment or causing unintended deployment.

    Product
    VOLKSWAGEN — VOLKSWAGEN ROUTAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V081000·2016-02-11

    Mercedes-Benz and Chrysler Recall Vehicles Due to Air Bag Inflator Defect

    Mercedes-Benz and Chrysler are recalling specific vehicles because the driver's frontal air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ, CHRYSLER E63, ML63, GL350, GL450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V082000·2016-02-11

    Starcraft RV Recalls 2016 Trailers Due to Water Heater Overheating Risk

    Starcraft RV is recalling 2016 Solstice and Travel Star trailers because water heaters may overheat, posing a scalding risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT, STARCRAFT RV FW TRAVEL STAR, SOLSTICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V084000·2016-02-11

    GM Recalls 2016 Vehicles for Missing Audio Safety Warnings

    General Motors is recalling 2016 Chevrolet and GMC vehicles because the radio may fail to provide audio warnings for unbelted drivers or keys left in the ignition.

    Product
    GMC — GMC, CHEVROLET SIERRA, SILVERADO, MALIBU, CAMARO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0532-2016·2016-02-10

    Dove Chocolate Assortment Snowflakes Recalled for Undeclared Peanuts and Eggs

    Mars Chocolate North America is recalling Dove Chocolate Assortment Snowflakes because the product may contain undeclared peanuts and egg ingredients.

    Product
    Dove Chocolate Assortment Snowflakes Net. Wt. 24.0 oz. Distributed by Mars Chocolate na, llc Hackettstown, NJ 07840-1503 USA UPC 400050521
    Category
    Food
    Distribution
    35 states
  • SevereFDA (Food)·F-0523-2016·2016-02-10

    Signature Breads Recalls Frozen French Sub Bread Due to Metal Fragments

    Signature Breads is recalling frozen parbaked French sub bread because it may contain metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V078000·2016-02-10

    Volkswagen and Audi Vehicles Recalled for Air Bag Inflator Rupture Risk

    Volkswagen Group of America is recalling specific 2007-2014 Volkswagen and Audi models because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI EOS, CC, Q5, PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0530-2016·2016-02-10

    Southeastern Grocers Recalls Bakery Cookies Due to Undeclared Walnuts

    Southeastern Grocers is recalling bakery variety pack cookies containing oatmeal raisin cookies due to undeclared walnuts. The recall affects stores in Florida, Georgia, and South Carolina.

    Product
    Bakery Variety Pack Cookies Containing Oatmeal Rasin Cookies packaged in clear plastic clamshell container, 12-count, 18-count, and 20-count
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0518-2016·2016-02-10

    Signature Breads Recalls Frozen French Petit Pain for Metal Fragments

    Signature Breads, Inc. is recalling 1,893 cases of frozen parbaked French Petit Pain bread due to potential metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0517-2016·2016-02-10

    Signature Breads Frozen Parbaked Baguettes Recalled for Metal Fragments

    Signature Breads is recalling frozen parbaked baguettes because they may contain metal fragments. The recall affects 1,893 cases distributed to New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0692-2016·2016-02-10

    Draeger Oxylog 3000 Ventilators Recalled for Software Error

    Draeger Medical is recalling Oxylog 3000 and Oxylog 3000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831. Volume controlled and pressure-controlled emergency and transport ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0691-2016·2016-02-10

    Draeger Oxylog 2000 Plus Ventilator Recalled for Malfunction

    Draeger Medical is recalling Oxylog 2000 Plus ventilators because a software error can stop ventilation and trigger alarms.

    Product
    Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0525-2016·2016-02-10

    Signature Breads Frozen Dinner Rolls Recalled for Metal Fragments

    Signature Breads is recalling frozen parbaked dinner rolls due to potential metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0745-2016·2016-02-10

    Philips Proton Therapy Planning Software Recalled for Dose Calculation Errors

    Philips Medical Systems is recalling DS/US Proton Feature software due to a defect that may cause incorrect dose calculations in radiation therapy planning.

    Product
    DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0526-2016·2016-02-10

    Herbal Supplement Recalled for Unapproved Human Placenta Ingredient

    Madison One Acme Inc. is recalling Tong Ren Tang Shenjing Shuairuo Wan because it contains unapproved human placenta, which may transmit disease.

    Product
    Tong Ren Tang Shenjing Shuairuo Wan Herbal Supplement 240 pills UPC Code: 6 904579 129602 Distributed by: Solstice Medicine Company
    Category
    Food
    Distribution
    27 states
  • SevereNHTSA·16V079000·2016-02-10

    Volkswagen Recalls Audi and Passat Vehicles for Airbag Inflator Defect

    Volkswagen is recalling 151,767 Audi and Volkswagen vehicles because the driver's airbag inflator may rupture during deployment, potentially causing serious injury.

    Product
    AUDI — AUDI, VOLKSWAGEN A3, A4 CABRIOLET, PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0516-2016·2016-02-10

    Signature Breads Recalls Frozen French Dinner Rolls Due to Metal Fragments

    Signature Breads is recalling 1,893 cases of frozen parbaked French dinner rolls because they may contain metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0524-2016·2016-02-10

    Signature Breads Frozen Petit Pain Recalled for Metal Fragments

    Signature Breads is recalling frozen parbaked Petit Pain bread due to potential metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16V077000·2016-02-10

    Daimler Vans Recalls Sprinter Vehicles Due to Air Bag Inflator Rupture Risk

    Daimler Vans is recalling 2007-2014 Dodge, Freightliner, and Mercedes-Benz Sprinter vans because the driver's air bag inflator may rupture during deployment.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ, DODGE SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0519-2016·2016-02-10

    Signature Breads Recalls Frozen French Sub Rolls Due to Metal Fragments

    Signature Breads, Inc. is recalling 1,893 cases of frozen parbaked French sub rolls because they may contain metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0510-2016·2016-02-10

    This Kid Saves Lives Chocolate Chip Bars Recalled for Undeclared Milk

    This Bar Saves Lives is recalling This Kid Saves Lives Chocolate Chip bars because they contain whey protein but do not identify milk on the label.

    Product
    This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0726-2016·2016-02-10

    Philips INTEGRIS Allura 9 Biplane Recalled for Image Interpretation Risk

    Philips is recalling INTEGRIS Allura 9 Biplane systems because still images may be misinterpreted as live images, posing a risk to patient safety.

    Product
    INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2016·2016-02-10

    Philips Recalls Allura Xper FD20 Biplane Systems Due to Image Display Error

    Philips is recalling Allura Xper FD20 Biplane systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent pl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and intervent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0724-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2016·2016-02-10

    Philips Allura Centron Medical Imaging System Recalled for Image Display Error

    Philips is recalling Allura Centron systems because a software error may cause still images to be misinterpreted as live images during medical procedures.

    Product
    Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0728-2016·2016-02-10

    Philips INTEGRIS Allura X-Ray Systems Recalled for Image Display Error

    Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.

    Product
    INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2016·2016-02-10

    Philips Allura Xper FD20/15 Recall for Image Display Error

    Philips is recalling 13,297 Allura Xper FD20/15 systems worldwide because a software error may cause still images to be interpreted as live images.

    Product
    Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0756-2016·2016-02-10

    BioMerieux Recalls API ZYM Bx2 Reagent Due to False Negative Results

    BioMerieux SA is recalling API ZYM Bx2 reagent because it produces false negative results, leading to discrepant identification outcomes in laboratory tests.

    Product
    API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical test including in the involved API strips.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0707-2016·2016-02-10

    Philips Allura Xper FD20 Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 systems because still images may be misinterpreted as live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.

    Product
    INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0714-2016·2016-02-10

    Philips Allura Xper OR Table Recalled for Image Interpretation Error

    Philips is recalling Allura Xper OR Tables because still images may be mistaken for live images, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0727-2016·2016-02-10

    Philips INTEGRIS Allura X-ray Systems Recalled for Image Display Error

    Philips is recalling INTEGRIS Allura X-ray systems because a software error may cause still images to be displayed as live images, potentially leading to misinterpretation.

    Product
    INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0718-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.

    Product
    INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0741-2016·2016-02-10

    Horiba ABX PENTRA Lactic Acid Reagent Recalled for Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Lactic Acid CP reagents because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (ab
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0744-2016·2016-02-10

    Acist Medical Systems Recalls BT2000 and CPT2000 Automated Manifold Kits

    Acist Medical Systems is recalling BT2000 and CPT2000 Automated Manifold Kits due to reports of air ingress into the manifold.

    Product
    ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and d
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0709-2016·2016-02-10

    Philips UNIQ and Allura Systems Recall for Image Interpretation Error

    Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2016·2016-02-10

    Mindray Recalls Panorama Patient Monitoring Network Software Due to Restart Issue

    Mindray is recalling Panorama Patient Monitoring Network software kits because the system may spontaneously restart, causing a temporary loss of monitoring.

    Product
    Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0713-2016·2016-02-10

    Philips Allura Xper FD20/20 Recall for Image Interpretation Error

    Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V075000·2016-02-10

    Toyota Recalls 2013-2016 Scion FR-S for Ignition Key Removal Defect

    Toyota is recalling 2013-2016 Scion FR-S vehicles because the ignition key may be removed without the transmission in Park, increasing the risk of the vehicle rolling away.

    Product
    SCION — SCION FR-S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0462-2016·2016-02-10

    Zatarain's Red Beans and Rice Recalled for Undeclared Milk Allergen

    Zatarain's is recalling Red Beans and Rice Original 8 oz. packages because they may contain an undeclared dairy allergen (milk).

    Product
    Zatarain's New Orleans Style RED BEANS AND RICE, ORIGINAL, NET WT 8 OZ, UPC 7142909849
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0512-2016·2016-02-10

    Signature Cafe Traditional Stuffing Recalled for Undeclared Allergens

    Taylor Farms Pacific is recalling Signature Cafe Traditional Stuffing because the label fails to declare soy, milk, and wheat.

    Product
    Signature Cafe Traditional Stuffing; Turkey Broth, Seasoned Bread Crumb Mix, Celery, Yellow Onion. Net WT. 39 oz. (2 lbs 7 oz) 1.1 kg. Perishable, Keep refrigerated. UPC 21130-08320 Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·16V080000·2016-02-10

    Thomas Built Buses Recall School Buses with Peeling Stop Arm Decals

    Daimler Trucks North America is recalling 878 school buses because reflective decals on stop arms may peel off, reducing visibility and increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0463-2016·2016-02-10

    Sun Noodle Recalls Tonkutsu Ramen for Undeclared Eggs

    Sun Noodle New Jersey, LLC is recalling 34,836 units of Tonkutsu Ramen because the product may contain undeclared eggs.

    Product
    Tonkutsu Ramen, Net Wt. 12 oz. Made by Sun Noodle Honolulu, HI 96819/Rancho Domingo, CA 90220/Teterboro, NJ 07605 UPC 0 85315 40003 5 PACKAGED IN PLASTIC CLEAR CLAMSHELL
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0702-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error

    Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.

    Product
    Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0729-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images.

    Product
    INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2016·2016-02-10

    Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination

    Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected bandages were distributed nationwide.

    Product
    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2016·2016-02-10

    Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

    Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2016·2016-02-10

    Philips UNIQ and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2016·2016-02-10

    Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2016·2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Risk

    Philips is recalling Allura Xper FD20 OR Tables because live and still images may be misinterpreted, potentially affecting diagnostic accuracy.

    Product
    Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placemen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0735-2016·2016-02-10

    MediChoice Cohesive Bandages Recalled for Microbial Contamination

    Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination.

    Product
    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0522-2016·2016-02-10

    Signature Breads Recalls Frozen French Mini Baguettes Due to Metal Fragments

    Signature Breads, Inc. is recalling 1,893 cases of frozen French mini baguettes because they may contain metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0748-2016·2016-02-10

    Radiometer AQURE System Recalled for Sample Type Design Error

    Radiometer America Inc is recalling 375 AQURE Systems (Model 933-599) because a design error may leave the sample type field blank, potentially leading to misinterpretation of blood gas and immunoassay results.

    Product
    AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0520-2016·2016-02-10

    Signature Breads French Dinner Rolls Recalled for Metal Fragments

    Signature Breads, Inc. is recalling Piantedosi French Dinner Rolls because the product may contain metal fragments. The recall affects 1,893 cases distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0722-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk

    Philips is recalling INTEGRIS and Allura medical imaging systems because software issues may cause still images to be misinterpreted as live images during procedures.

    Product
    INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V076000·2016-02-10

    Ram ProMaster Vans Recalled for Electronic Stability Control Defect

    Chrysler is recalling 2016 Ram ProMaster vans with 3.0L diesel engines because the Electronic Stability Control system may fail to reactivate after being disabled, increasing crash risk.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0521-2016·2016-02-10

    Signature Breads Recalls Frozen French Dinner Rolls for Metal Fragments

    Signature Breads is recalling 1,893 cases of frozen parbaked French dinner rolls due to potential metal fragments. The product was distributed in New Hampshire, Pennsylvania, and Florida.

    Product
    Signature Breads Frozen Parbaked French Dinner Rolls 22251; 280 Units - 1 OZ, NET WT. 17.5 LB (7.93 kg), in a cardboard box
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0703-2016·2016-02-10

    Philips Allura Xper X-ray Systems Recalled for Image Display Error

    Philips is recalling Allura Xper FD10/10 systems because a software issue may cause still images to be mistaken for live images during X-ray procedures.

    Product
    Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0705-2016·2016-02-10

    Philips Allura Xper FD20/10 Recalled for Image Display Error

    Philips is recalling 13,297 Allura Xper FD20/10 systems because a software error may cause still images to be interpreted as live images.

    Product
    Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0704-2016·2016-02-10

    Philips Allura Xper OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular procedures.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2016·2016-02-10

    Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation

    The Anspach Effort, Inc. is recalling 599 Synthes Small Electric Drive units because they may malfunction, fail to operate, or start unintentionally.

    Product
    Synthes Small Electric Drive (SED). For use in general traumatology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0746-2016·2016-02-10

    Resmed Recalls Astral 100 and 150 External Batteries Due to Start-Up Issue

    Resmed Corporation is recalling Astral 100 and 150 external batteries because of a start-up issue. The recall affects 14,736 units distributed in the US and internationally.

    Product
    Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breath
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0717-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Display Error

    Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0696-2016·2016-02-10

    Global Healthcare Recalls ET-20 Anesthesia Extension Tubes Due to Kinking

    Global Healthcare Inc. is recalling 2,000 cases of ET-20 Anesthesia Extension Tubes distributed in Georgia due to potential kinking that may pose a health hazard.

    Product
    ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0733-2016·2016-02-10

    Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination

    Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected products were distributed nationwide.

    Product
    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2016·2016-02-10

    Bard Denali Intravascular Filters Recalled for Missing Contraindications

    Bard Peripheral Vascular Inc is recalling 1,183 Denali intravascular filters because the instructions for use are missing critical contraindications regarding sepsis and nickel-titanium allergies.

    Product
    Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0739-2016·2016-02-10

    Horiba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference

    Horiba Instruments Inc. is recalling ABX PENTRA Enzymatic Creatinine CP reagent because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0754-2016·2016-02-10

    Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.

    Product
    ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2016·2016-02-10

    bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.

    Product
    BacT/ALERT¿ SN, bioM¿rieux, Inc. Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0652-2016·2016-02-10

    Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength

    Perrigo is recalling 918 units of Nystatin USP Powder due to a labeling error regarding the declared strength. The product was distributed nationwide.

    Product
    Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0731-2016·2016-02-10

    Baxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim

    Baxter is recalling RAPIDFILL Syringe Strips because the packaging claims a 12-month shelf life without supporting evidence.

    Product
    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2016·2016-02-10

    Perrigo Recalls Nystatin Powder for Labeling Error on Declared Strength

    Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding due to a labeling error regarding the declared strength.

    Product
    Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0699-2016·2016-02-10

    Smith & Nephew Recalls Oversized Biosure Orthopedic Screw Drivers

    Smith & Nephew is recalling 157 Biosure Drivers that are oversized and may fail to insert screws properly or cause screws to stick.

    Product
    Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0648-2016·2016-02-10

    Pfizer Recalls Lyrica Capsules Due to Deformed or Damaged Shells

    Pfizer is recalling specific lots of Lyrica (pregabalin) 50 mg capsules due to the potential presence of deformed or damaged capsules.

    Product
    LYRICA — LYRICA (PREGABALIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2016·2016-02-10

    Smith & Nephew Recalls Oversized Biosure Ratchet Driver for Orthopedic Screws

    Smith & Nephew is recalling nine Biosure Ratchet Drivers because they are oversized and may not fit screws properly or may cause screws to stick.

    Product
    Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0743-2016·2016-02-10

    Horiba ABX PENTRA Uric Acid CP Recalled for Interference

    Horiba Instruments Inc is recalling ABX PENTRA Uric Acid CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0742-2016·2016-02-10

    Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference

    Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.

    Product
    ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with a
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0740-2016·2016-02-10

    Horiba ABX PENTRA Glucose Reagent Recalled for NAC Interference

    Horiba Instruments Inc is recalling ABX PENTRA Glucose reagents because N-acetylcysteine in patient blood can cause falsely low glucose results.

    Product
    ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0755-2016·2016-02-10

    Siemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues

    Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.

    Product
    ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte (IS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2016·2016-02-10

    Olympus TJF-Q180V Duodenoscope Recall for Forceps Elevator Mechanism Replacement

    Olympus is voluntarily removing all TJF-Q180V duodenoscopes to replace the forceps elevator mechanism with a new design consistent with recent 510(k) specifications.

    Product
    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0732-2016·2016-02-10

    JosNoe PS-500 Scope Warmer Recalled for Package Seal Damage

    JosNoe Medical is recalling PS-500 Scope Warmers because damaged package seals may compromise sterility. The recall covers 1,008 boxes distributed in the US and Canada.

    Product
    PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0738-2016·2016-02-10

    Horiba ABX PENTRA Cholesterol CP Reagent Recalled for Interference

    Horiba Instruments Inc is recalling 216 units of ABX PENTRA Cholesterol CP reagent because N-acetylcysteine can cause falsely low results.

    Product
    The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a c
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0736-2016·2016-02-10

    Instrumentation Laboratory Recalls HemosIL Plasminogen IVD Kits

    Instrumentation Laboratory is recalling specific lots of HemosIL Plasminogen kits because they do not meet labeled stability claims.

    Product
    HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0750-2016·2016-02-10

    bioMérieux Recalls BacT/ALERT FA Culture Bottles Due to Shipping Exposure

    bioMérieux is recalling 2,741 BacT/ALERT FA culture bottles because non-normal shipping conditions may have degraded the media, potentially affecting microbial detection performance.

    Product
    BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0650-2016·2016-02-10

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.

    Product
    Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V074000·2016-02-09

    Honda Recalls 2016 Civics Due to Engine Piston Defect

    Honda is recalling 2016 Civic vehicles with 2.0L engines because missing or incorrect piston circlips may cause engine seizure, increasing the risk of a crash or fire.

    Product
    HONDA — HONDA CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide

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