The Recall Desk

Archive

March 2014 recalls

554 recalls were announced in March 2014.

What the numbers show

Critical
40
Severe
147
High
238
Moderate
117
Low
12

Of the 554 recalls this month scored against our rubric, 7% are Critical, 27% are Severe.

401–500 of 554

  • SevereNHTSA·14E007000·2014-03-07

    Gates Recalls Tru-Flow Water Pumps for Timing Belt Failure Risk

    Gates is recalling specific aftermarket Tru-Flow water pumps for Audi and Volkswagen vehicles because the pulley may develop microfractures, causing the timing belt to fail and the engine to shut down.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI BEETLE, PASSAT, JETTA, TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14720·2014-03-07

    ZLP Hornet Zip Line Trolleys Recalled Due to Fall Hazard

    ZLP Manufacturing is recalling about 2,000 Hornet zip line trolleys because a retaining pin can release, causing the trolley to fall off the line.

    Product
    LP Hornet zip line trolleys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·14125·2014-03-06

    Packaging Tape Recalls Air Movers Due to Fire Hazard

    Packaging Tape is recalling about 2,800 air movers sold from 2008 to 2010 because a thermal switch failure can cause the motor to overheat and start a fire.

    Product
    Air movers/blowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14126·2014-03-06

    Design Ideas Recalls Rubber Ducky, Blowfish, and Splat Magnets Due to Ingestion Risk

    Design Ideas is recalling approximately 26,900 miniature magnets in the shapes of ducks, blowfish, and splats because the small magnets can detach and be swallowed by children.

    Product
    Design Ideas® and Neatlife® Rubber Ducky Magnets, and Design Idea® Blowfish and Splat Magnets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14127·2014-03-06

    Tektro USA and TRP Recall Bicycle Mechanical Disc Brake Calipers

    Tektro USA and TRP are recalling Spyre and Spyre SLC mechanical disc brake calipers because the actuator arm can over-rotate, causing brake failure and a crash hazard.

    Product
    Spyre and Spyre SLC dual-piston mechanical disc brake calipers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·14128·2014-03-06

    Canon Recalls PowerShot SX50 HS Cameras for Chemical Irritation Risk

    Canon is recalling about 14,000 PowerShot SX50 HS digital cameras because a chemical in the viewfinder rubber can cause skin or eye irritation. Consumers should stop using the cameras and contact Canon for a free repair.

    Product
    Canon PowerShot SX50 HS Digital Cameras
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0951-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1543-2014·2014-03-05

    The Cultured Kitchen Recalls Smoked Cheddar Cashew Cheese for Salmonella Risk

    The Cultured Kitchen is recalling Smoked Cheddar Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.

    Product
    The Cultured Kitchen Smoked Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 7362
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0957-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0950-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1544-2014·2014-03-05

    The Cultured Kitchen Recalls Pepper Jack Cashew Cheese Due to Salmonella Risk

    The Cultured Kitchen is recalling Pepper Jack Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.

    Product
    The Cultured Kitchen Pepper Jack Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-0956-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1548-2014·2014-03-05

    UNFI Recalls Kinnikinnick Waffles Due to Undeclared Milk Allergen

    UNFI is recalling Kinnikinnick Original Homestyle Waffles nationwide because the product contains undeclared milk. Consumers should stop eating the product and return it to the store.

    Product
    Kinnikinnick Original Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300198 1
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1105-2014·2014-03-05

    Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.

    Product
    HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1550-2014·2014-03-05

    UNFI Recalls Kinnikinnick Bread Mix for Undeclared Milk Allergen

    UNFI is recalling Kinnikinnick Kinni-Kwik Bread & Bun Mix nationwide due to undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    Kinnikinnick Kinni-Kwik Bread & Bun Mix-Weight 350g/16oz Cardboard Box UPC 62013310550 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1556-2014·2014-03-05

    Unified Grogers Recalls Ginger Snap Cookies for Undeclared Egg

    Unified Grocers is recalling 12 oz. Ginger Snap Cookies because they contain undeclared egg. The recall affects products distributed in California, Arizona, and Nevada.

    Product
    Ginger Snap Cookies, 12 oz., Item Code: 48918, UPC 0-41380-23359
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1089-2014·2014-03-05

    Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk

    Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.

    Product
    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1109-2014·2014-03-05

    Philips HeartStart XL Defibrillators Recalled for Power Board Failure

    Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.

    Product
    Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1102-2014·2014-03-05

    Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.

    Product
    Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1542-2014·2014-03-05

    The Cultured Kitchen Recalls Herb Cashew Cheese Due to Salmonella Risk

    The Cultured Kitchen is recalling six varieties of Herb Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.

    Product
    The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922714
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1551-2014·2014-03-05

    UNFI Recalls Kinnikinnick Pancake Mix for Undeclared Milk

    UNFI is recalling Kinnikinnick Pancake & Waffle Mix nationwide due to undeclared milk, a major allergen.

    Product
    Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2014·2014-03-05

    Philips BrightView Gamma Cameras Recalled for Patient Contact Risk

    Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.

    Product
    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2014·2014-03-05

    Caraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence

    Caraco Pharmaceutical is recalling 2,528 bottles of Metformin HCl ER 500 mg tablets because a customer reported finding Gabapentin tablets in the bottle.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1091-2014·2014-03-05

    Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw

    Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.

    Product
    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which read
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1069-2014·2014-03-05

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.

    Product
    VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V106000·2014-03-05

    Daimler Orion VII Transit Buses Recalled for Exhaust Fire Risk

    Daimler Buses North America is recalling 2007-2012 Orion VII transit buses because condensation in the intake manifold may freeze, causing elevated exhaust temperatures or flames.

    Product
    ORION — ORION VII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14120·2014-03-05

    Twin-Star Recalls Duraflame Electric Space Heaters Due to Fire and Burn Hazards

    Twin-Star is recalling about 31,000 Duraflame electric space heaters because they can overheat, melt, and catch fire. Consumers should unplug the units and contact the company for a refund.

    Product
    Duraflame electric space heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1545-2014·2014-03-05

    The Cultured Kitchen Recalls Cashew Cheese for Salmonella Risk

    The Cultured Kitchen is recalling six varieties of cashew cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.

    Product
    The Cultured Kitchen Habanero Cilantro Lime Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1049-2014·2014-03-05

    Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect

    Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.

    Product
    CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1077-2014·2014-03-05

    DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects

    DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.

    Product
    PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-1549-2014·2014-03-05

    UNFI Recalls Kinnikinnick Waffles for Undeclared Milk Allergen

    UNFI is recalling Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles nationwide due to undeclared milk. The recall is voluntary and classified as Class I.

    Product
    Kinnikinnick Cinnamon & Brown Sugar Homestyle Waffles-Weight: 210 g/7.4oz Qty/Pkg: 6 Cardboard Box-UPC: 62013300199 8
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1552-2014·2014-03-05

    UNFI Recalls Kinnikinnick Panko Bread Crumbs for Undeclared Milk

    UNFI is recalling Kinnikinnick Panko Style Bread Crumbs nationwide due to undeclared milk, a major allergen.

    Product
    Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2014·2014-03-05

    Elekta Recalls DMLC IV-ERGO Systems Due to Gantry Sensor Error

    Elekta, Inc. is recalling 35 DMLC IV-ERGO systems because an intermittent error may occur in the gantry sensor. The devices are used with linear accelerators for radiation therapy.

    Product
    DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2014·2014-03-05

    Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2014·2014-03-05

    Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.

    Product
    Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2014·2014-03-05

    Winco XL Convalescent Recliner Recalled Due to Assembly Defect

    Winco Mfg. is recalling 369 XL Convalescent Recliners due to a manufacturing defect in the right-hand recline mechanism that may cause loss of the position lock bar functionality.

    Product
    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14E006000·2014-03-05

    Meritor Wabco Recalls Trailer Spring Brake Control Valves

    Meritor Wabco is recalling specific trailer spring brake control valves sold as replacement parts because the intake/exhaust valve may come apart, preventing the parking brake from engaging.

    Product
    PARKING BRAKE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2014·2014-03-05

    Fresenius Optiflux F160NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 units distributed in the US and Mexico.

    Product
    Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2014·2014-03-05

    Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.

    Product
    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1554-2014·2014-03-05

    Kinnikinnick Pancake and Waffle Mix Recalled for Undeclared Milk

    Bozzutos Inc. is recalling Kinnikinnick Pancake & Waffle Mix due to undeclared milk, a major food allergen.

    Product
    Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1054-2014·2014-03-05

    Medline Recalls Surgical Kits with Flaking Guidewire Coating

    Medline Industries is recalling five surgical kits containing a guidewire with a potential coating flake-off defect.

    Product
    STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2014·2014-03-05

    Medline Recalls Angio Pack #2 Surgical Kits Due to Coating Defect

    Medline Industries is recalling 768 units of Angio Pack #2 surgical kits because a guidewire component has a potential for its coating to flake off.

    Product
    ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2014·2014-03-05

    Medline Recalls Surgical Kits with Flaking Guidewire Coating

    Medline Industries is recalling 112 surgical kits containing guidewires with a potential for coating to flake off.

    Product
    CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1547-2014·2014-03-05

    The Cultured Kitchen Recalls White Cheddar Cashew Cheese for Salmonella Risk

    The Cultured Kitchen is recalling White Cheddar Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including 4/19/2014.

    Product
    The Cultured Kitchen White Cheddar Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 7945049
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0955-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1555-2014·2014-03-05

    Kinnikinnick Panko Bread Crumbs Recalled for Undeclared Milk Allergen

    Bozzutos' Inc. is recalling Kinnikinnick Panko Style Bread Crumbs due to undeclared milk. The product was distributed in several northeastern states.

    Product
    Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0960-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1050-2014·2014-03-05

    Medline Recalls Surgical Kits With Flaking Guidewire Coating

    Medline Industries is recalling 304 surgical kits containing guidewires with a potential for coating to flake off.

    Product
    CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling specific lots of ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising airway maintenance.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2014·2014-03-05

    Medline Recalls Angiography Drape Packs Due to Guidewire Coating Defect

    Medline Industries is recalling 50 units of CATH ANGIOGRAPHY DRAPE PACKS because a guidewire inside the kits has a potential for its coating to flake off.

    Product
    CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1046-2014·2014-03-05

    Medline Recalls Angiography Packs Due to Guidewire Coating Flaking Risk

    Medline Industries is recalling 1,194 angiography packs because a guidewire component may have flaking coating. The recall covers distribution in seven US states.

    Product
    ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0953-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0959-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2014·2014-03-05

    Smith & Nephew Recalls Reflection Interfit Shell Due to Undersized Radius

    Smith & Nephew is recalling 10 units of Reflection Interfit Shells because the inner spherical radius is undersized. The affected devices were distributed in the US and internationally.

    Product
    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1108-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect

    Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.

    Product
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by tra
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Food)·F-1586-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with coconut-pineapple filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***coconut-pineapple filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1562-2014·2014-03-05

    Newman's Own Salsa Con Queso Recalled for Undeclared Wheat

    Newman's Own is recalling Salsa Con Queso, Medium All Natural, 16 oz. jars nationwide due to undeclared wheat.

    Product
    Newman's Own Salsa Con Queso, Medium All Natural Net Wt.16 oz., packaged in a glass jar UPC 0 20662 00353 9
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1571-2014·2014-03-05

    CSM Bakery Recalls Pistachio Muffins for Undeclared Coconut

    CSM Bakery Products NA is recalling 60 cases of frozen pistachio muffins because they may contain undeclared coconut.

    Product
    Multifoods Bakery Products, Artificial Pistachio Flavored Muffin with Other Nuts, 4.5oz (frozen muffin batter in muffing liner, inside plastic tray, overwrapped with plastic, packaged in corrugate case), 27 lbs case is unit for sale. UPC 024800486383. Manufactured by CSM Bakery
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1092-2014·2014-03-05

    Zimmer Trabecular Metal Shoulder Humeral Stem Recalled for Bond Strength Defect

    Zimmer, Inc. is recalling 10 units of Trabecular Metal Shoulder Humeral Stems because testing found bond strength below the minimum required specification in one zone.

    Product
    00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder p
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1578-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. is recalling Brazo gitano (rolled cake) with cheese filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1097-2014·2014-03-05

    Ossur Recalls Symbionic Leg Due to Battery Warning Failure

    Ossur is recalling 144 Symbionic Leg prosthetics because they fail to display a low battery warning before powering down.

    Product
    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2014·2014-03-05

    Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results

    Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.

    Product
    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1580-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with bavarian cream filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***bavarian cream cake filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1579-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Rolls for Undeclared Wheat

    E. Franco & Co. Inc is recalling approximately 2,300 14-ounce rolls of Brazo Gitano with chocolate cake filling distributed in Puerto Rico due to undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***chocolate cake filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1582-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with guava-cheese filling because it contains undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***guava-cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1546-2014·2014-03-05

    The Cultured Kitchen Recalls Six Cashew Cheese Varieties Due to Salmonella Risk

    The Cultured Kitchen is recalling six varieties of cashew cheese with expiry dates up to April 19, 2014, due to potential Salmonella contamination.

    Product
    The Cultured Kitchen Pesto or Basil Pesto Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UP
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1577-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo gitano (rolled cake) with mango filling due to undeclared wheat allergens. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***mango filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1553-2014·2014-03-05

    Popcorn Factory Recalls Heart-Shaped Popcorn Balls Due to Missing Allergen Labels

    The Popcorn Factory is recalling heart-shaped popcorn balls because the Nutrition Facts and allergen labels were not applied to the individual pieces. The product contains milk and soy allergens.

    Product
    Candy coated popcorn shaped into a heart weighing 1.5 ounces per piece and individually wrapped in clear plastic packaging. There are 24 popcorn balls per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1585-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling Brazo Gitano rolled cakes with chocolate filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***chocolate filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1560-2014·2014-03-05

    Creation Gardens Recalls Bar Star Snack Mix for Missing Allergen Labels

    Creation Gardens is recalling Bar Star Snack Mix because the packaging lacks required ingredient and allergen statements, including peanuts, tree nuts, soy, and wheat.

    Product
    Bar Star Snack Mix, 1 lb plastic bag and 25 lb plastic bags in a cardboard box. Box labeled DAYTON'S ESTABLISHED 1923 DAYTON NUT SPECIALTIES, INC. 919 N. MAIN DAYTON, OHIO 45405 with a white stick on label which reads, "25# BAR STAR MIX
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1559-2014·2014-03-05

    Marlyce's Homemade Style Noodles Recalled for Undeclared Wheat Allergen

    L.M. Noodle Company is recalling Marlyce's Homemade Style Noodles because the label fails to declare wheat flour, a major allergen.

    Product
    Marlyce's Homemade Style Noodles, Net Wt. 8 oz, Packaged in plastic bags, 10 per case, UPC 094219217069. Manufactured by L.M.Noodle Company, LLC, 416 Main Street, Wiggins, CO 80654.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1581-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc is recalling approximately 2,300 rolls of Brazo Gitano lemon filling cakes sold in Puerto Rico due to undeclared wheat.

    Product
    "***Brazo gitano (rolled cake)***lemon filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1572-2014·2014-03-05

    E. Franco & Co. Recalls Rolled Cakes Due to Undeclared Wheat Allergen

    E. Franco & Co. Inc is recalling approximately 2,300 rolls of Brazo gitano (rolled cake) with pineapple paste filling because the product contains undeclared wheat. The recall is limited to Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pineapple paste filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1573-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Cakes for Undeclared Wheat

    E. Franco & Co. Inc. is recalling Brazo gitano (rolled cake) with pumpkin paste filling because it contains undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pumpkin paste filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1589-2014·2014-03-05

    Natural Grocers Recalls Dark Chocolate Almonds for Undeclared Peanuts

    Natural Grocers by Vitamin Cottage is recalling Dark Chocolate Almonds because some bags may contain undeclared peanuts.

    Product
    Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1576-2014·2014-03-05

    E. Franco & Co. Recalls Brazo Gitano Rolls for Undeclared Wheat

    E. Franco & Co. is recalling Brazo Gitano rolled cakes with coconut filling because they contain undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***coconut filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1588-2014·2014-03-05

    E. Franco & Co. Recalls Rolled Cakes with Undeclared Wheat Allergen

    E. Franco & Co. Inc is recalling Brazo gitano rolled cakes with pineapple-cheese filling due to undeclared wheat. The product was distributed in Puerto Rico.

    Product
    "***Brazo gitano (rolled cake)***pineapple-cheese filling***"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1048-2014·2014-03-05

    Medline Recalls Heart Catheter Kits Due to Coating Defect

    Medline Industries is recalling 160 Heart Cath Custom Packs because a guidewire component may have a flaking coating.

    Product
    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1052-2014·2014-03-05

    Medline Recalls Surgical Kits with Potential Coating Defect on Guidewires

    Medline Industries is recalling 10 surgical kits containing guidewires with a potential coating defect. The kits were distributed to specific US states.

    Product
    STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures..
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1051-2014·2014-03-05

    Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect

    Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking defect.

    Product
    CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2014·2014-03-05

    Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints

    Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.

    Product
    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2014·2014-03-05

    Winco Drop-Arm Convalescent Recliners Recalled for Mechanism Defect

    Winco Mfg. is recalling 369 drop-arm convalescent recliners due to a manufacturing defect that may cause the three-position lock bar to lose functionality.

    Product
    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1070-2014·2014-03-05

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda infant resuscitation systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2014·2014-03-05

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination

    Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement because the product may contain high levels of microbial contamination.

    Product
    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samp
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1120-2014·2014-03-05

    Philips HeartStart MRx Defibrillator Batteries Recalled for Shutdown Risk

    Philips is recalling 43,792 HeartStart MRx defibrillator batteries because they may shut down unexpectedly when exposed to high electromagnetic interference.

    Product
    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2014·2014-03-05

    Siemens Artis zee Ceiling Systems Recalled for Cable Damage Risk

    Siemens Medical Solutions USA is recalling 284 Artis zee Ceiling Systems due to potential cable damage from sub-optimal guidance.

    Product
    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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