The Recall Desk

Archive

August 2016 recalls

766 recalls were announced in August 2016.

What the numbers show

Critical
77
Severe
169
High
248
Moderate
235
Low
37

Of the 766 recalls this month scored against our rubric, 10% are Critical, 22% are Severe.

1–100 of 766

  • CriticalFDA (Food)·F-1986-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Roman Shmaltz Herring for Listeria Risk

    SM Fish Corp. is recalling Ossie's Roman Shmaltz Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S ROMAN SHMALTZ HERRING, NET WT. 7 OZ., UPC 739885109026; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1985-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Shmaltz Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Shmaltz Herring because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S SHMALTZ HERRING, NET WT. 8 OZ., UPC 739885104182; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1981-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Swedish Matjes Herring for Listeria Risk

    SM Fish Corp. is recalling Ossie's Swedish Matjes Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S SWEDISH MATJES HERRING, NET WT. 7 OZ., UPC 739885109101; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2649-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond

    Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2016·2016-08-31

    Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture

    Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1977-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Herring in Sourcream Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Herring in Sourcream because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ., UPC 739885114174; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2665-2016·2016-08-31

    Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity mea
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1463-2016·2016-08-31

    Talon Compounding Pharmacy Recalls Sermorelin Injections Due to Sterility Concerns

    Talon Compounding Pharmacy is recalling Sermorelin and Sermorelin/GHRP-2 injections because the FDA cannot assure the products are sterile.

    Product
    Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1976-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox Dairy because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ., UPC 739885114136; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2610-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture

    Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1980-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Wasabi Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Wasabi Herring because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S WASABI HERRING, NET WT. 7 OZ., UPC 739885109088; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2660-2016·2016-08-31

    Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1989-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED LOX, NET WT. 8 OZ., UPC 739885104137; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2612-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1982-2016·2016-08-31

    SM Fish Corp. Recalls Dublin Herring for Listeria Risk

    SM Fish Corp. is recalling Ossie's Dublin Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S DUBLIN HERRING, NET WT. 7 OZ., UPC 739885109002; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1954-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish and Razor Clams

    Northwest Wild Products is recalling canned fish and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Columbia River Chinook Salmon -Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1952-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Coho Salmon- Custom Smoked, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1988-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Herring Clear due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED HERRING CLEAR, NET WT. 8 OZ., UPC 739885104205; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2618-2016·2016-08-31

    Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture

    Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2620-2016·2016-08-31

    Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture

    Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.

    Product
    Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2596-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-2615-2016·2016-08-31

    Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

    Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

    Product
    FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for eva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2597-2016·2016-08-31

    Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk

    Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • SevereFDA (Devices)·Z-2662-2016·2016-08-31

    Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.

    Product
    Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain informati
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2616-2016·2016-08-31

    Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets

    Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.

    Product
    Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1959-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products due to potential Clostridium botulinum contamination.

    Product
    Oregon Sardines - Spicy Tomato-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2650-2016·2016-08-31

    Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators

    Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.

    Product
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2621-2016·2016-08-31

    Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2666-2016·2016-08-31

    Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

    Product
    Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2661-2016·2016-08-31

    Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.

    Product
    SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain info
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2609-2016·2016-08-31

    Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect

    Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.

    Product
    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2619-2016·2016-08-31

    Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture

    Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2623-2016·2016-08-31

    Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture

    Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1983-2016·2016-08-31

    SM Fish Corp. Recalls Honey Mustard Herring for Listeria Risk

    SM Fish Corp. is recalling 336 containers of Ossie's Honey Mustard Herring due to potential Listeria monocytogenes contamination. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S HONEY MUSTARD HERRING; NET WT. 7 OZ. 739885109019; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2617-2016·2016-08-31

    Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk

    Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2016·2016-08-31

    Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters

    Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.

    Product
    Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1978-2016·2016-08-31

    SM Fish Corp. Recalls Herring Due to Listeria Contamination Risk

    SM Fish Corp. is recalling Ossie's Taam Shabbos Herring because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S TAAM SHABBOS HERRING, NET WT. 7 OZ., UPC 739885109057; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1961-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood for Botulism Risk

    Northwest Wild Products is recalling various canned seafood products due to potential Clostridium botulinum contamination. Consumers should check can codes and stop using affected items.

    Product
    Pacific White Albacore Tuna - Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2614-2016·2016-08-31

    Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture

    Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.

    Product
    Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2613-2016·2016-08-31

    Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture

    Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.

    Product
    Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1960-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products, including sturgeon, due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Sturgeon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1955-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood for Botulism Risk

    Northwest Wild Products is recalling various canned seafood products due to potential Clostridium botulinum contamination. Consumers should check for codes starting with OC.

    Product
    Columbia River Chinook Salmon -Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1964-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling canned fish products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Pacific Black Cod- Custom Smoked -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2651-2016·2016-08-31

    Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

    Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

    Product
    Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardiov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2664-2016·2016-08-31

    Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk

    Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.

    Product
    Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1951-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling canned black cod, salmon, sardines, steelhead, sturgeon, tuna, and razor clams with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Pacific Black Cod, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V634000·2016-08-31

    Daimler Trucks Recalls 2014-2017 Models Due to Front Axle Hub Failure Risk

    Daimler Trucks North America is recalling specific 2014-2017 Freightliner and Western Star trucks because front axle hubs may fail, causing the wheel to separate from the axle.

    Product
    FREIGHTLINER — FREIGHTLINER, WESTERN STAR CORONADO, BUSINESS CLASS M2, 4800, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2663-2016·2016-08-31

    Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating

    Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.

    Product
    Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been d
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1958-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including sardines, due to potential Clostridium botulinum contamination.

    Product
    Oregon Sardines - Mustard-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1956-2016·2016-08-31

    Northwest Wild Products Recalls Canned Fish Due to Botulism Risk

    Northwest Wild Products is recalling various canned fish products because they may be contaminated with Clostridium botulinum.

    Product
    Wild Steelhead Salmon - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1962-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling canned seafood, including razor clams, due to potential Clostridium botulinum contamination. The products were distributed in Oregon via mail order.

    Product
    Wild Northwest Razor Clams - Custom Smoked-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1984-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Lox Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Lox & Cream because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ., UPC 739885104113; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1979-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Stiglitz Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Stiglitz Herring in New York and New Jersey because the manufacturing plant tested positive for Listeria monocytogenes.

    Product
    OSSIE'S STIGLITZ HERRING, NET WT. 7 OZ., UPC 739885109064; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1957-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Steelhead Salmon - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1963-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including razor clams, because they may be contaminated with Clostridium botulinum.

    Product
    Wild Northwest Razor Clams - Custom Packed-NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Package
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2016·2016-08-31

    Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1966-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products, including tuna, salmon, and black cod, due to potential Clostridium botulinum contamination.

    Product
    Pacific White Albacore Tuna - Custom Packed -NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1953-2016·2016-08-31

    Northwest Wild Products Recalls Canned Seafood Due to Botulism Risk

    Northwest Wild Products is recalling various canned seafood products with codes starting with OC due to potential Clostridium botulinum contamination.

    Product
    Wild Columbia River Coho Salmon- Custom Packed, NW Wild Products, 6.5 oz. metal cans. No UPC
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2641-2016·2016-08-31

    Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling two Ziehm Vision RFD mobile C-arms because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-1968-2016·2016-08-31

    English Bay Cinnamon Rolls Recalled for Allergen Labeling Error

    English Bay Batter Inc is recalling cinnamon rolls because the packaging states 'May Contain Milk' instead of 'Contains Milk'.

    Product
    CINNAMON ROLLS WITH CREAM CHEESE ICING Quality & Value pics BY PRICE CHOPPER NET WT 12.4 OZ (351g) INGREDIENTS: ***CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURES***. CONTAINS WHEAT. MAY CONTAIN MILK, EGGS, SOY, PEANUTS AND TREE NUTS. DISTRIBUTED BY: PRICE CHOPPER, INC.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1948-2016·2016-08-31

    Montana Flour & Grains Recalls Organic Spelt Grain for Wheat Mislabeling

    Montana Flour & Grains is recalling 100% Organic Spelt Grain because the label fails to declare wheat, a major allergen.

    Product
    100% Organic Spelt Grain, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2645-2016·2016-08-31

    Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk

    Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.

    Product
    DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimula
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2598-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Potential Burn Risk

    Conmed Corporation is recalling Adult Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, creating a risk of undetected pad lift and potential burns.

    Product
    Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.0
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2602-2016·2016-08-31

    Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage

    Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.

    Product
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1987-2016·2016-08-31

    SM Fish Corp. Recalls Ossie's Pickled Herring Due to Listeria Risk

    SM Fish Corp. is recalling Ossie's Pickled Herring in 8 oz. plastic tubs because the manufacturing plant tested positive for Listeria monocytogenes. The product was distributed in New York and New Jersey.

    Product
    OSSIE'S PICKLED HERRING, NET WT. 8 OZ., UPC 739885104175; -- Far Rockaway, NY 11691 --- The product is packed in a plastic deli tub.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·16V633000·2016-08-31

    Peterbilt 567 Truck Recalled for Tripping Hazard on Left Rail

    PACCAR is recalling one 2017 Peterbilt 567 truck because a bracket protrudes upward, creating a tripping hazard. Dealers will move the connections to the right rail free of charge.

    Product
    PETERBILT — PETERBILT 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2016·2016-08-31

    Medtronic Recalls Tibial Tray Components Due to Passivation Defect

    Medtronic is recalling three units of tibial tray components for total knee replacement because they may not have been passivated correctly.

    Product
    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2599-2016·2016-08-31

    Conmed Pediatric Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling 4,560 pediatric dual dispersive electrodes because they may be incompatible with some generators, risking undetected pad lift and potential burns.

    Product
    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10'
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-1970-2016·2016-08-31

    Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Recalled for Peanut Residue

    Mondelez International is recalling Nabisco Honey Maid Teddy Grahams Cinnamon Cubs because they were produced using flour containing peanut residue.

    Product
    Nabisco Honey Maid Teddy Grahams Cinnamon Cubs Graham Snacks Net Wt .5 oz (14g) Distributed by Mondelez Global LL East Hanover, NJ 07936 USA UPC 019320016769
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1973-2016·2016-08-31

    La Torre Copito Marshmallow Chocolate Cookie Recalled for Milk Allergen Mislabeling

    La Torre Foods is recalling Copito Marshmallow Chocolate Cookies because the label lists calcium caseinate but fails to declare milk, a major allergen.

    Product
    la Torre Copito Marshmallow Chocolate Cookie NET WT 4.94 oz packaged in a cardboard box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2658-2016·2016-08-31

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect

    Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.

    Product
    Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V629000·2016-08-31

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks North America is recalling 2015-2017 Thomas Built Buses equipped with specific Ricon wheelchair lifts. Defective pivot holes may allow bearings to move, causing the lift platform to fall and injure the operator.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER EFX, MINOTOUR, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2648-2016·2016-08-31

    Bovie Precise 360 Handpiece Recalled for Incomplete Adhesive Bond

    Bovie Medical Corporation is recalling 95 units of the BVX-450BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.

    Product
    BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2016·2016-08-31

    Richard Wolf Conical Portio Adapter Recall Due to Weld Defect

    Richard Wolf Medical Instruments Corp. is recalling specific batches of Conical Portio Adapters because an improper weld may cause the device to separate during use.

    Product
    Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecological laparoscopy, to determine patency of the fallopian tubes.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1972-2016·2016-08-31

    Eatin' Alive Recalls Thai Wrap and Noodles for Undeclared Soy

    Paige Common dba Eatin' Alive is recalling Thai Peanut Noodles and Thai Wrap because they contain undeclared soy.

    Product
    Eatin' Alive VEGAN GLUTEN FREE RAW thai wrap. Keep Refrigerated. 6oz UPC 0 91037 56620
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2361-2016·2016-08-31

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate INR Readings

    Alere San Diego is voluntarily recalling INRatio PT/INR test strips and meters because they may display therapeutic INR values that are significantly higher in central laboratory testing.

    Product
    Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time reacti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2643-2016·2016-08-31

    Ziehm Solo Mobile C-arm Recalled for Radiation Warning Timer Malfunction

    Ziehm Imaging Inc is recalling 12 Ziehm Solo Mobile C-arms because the radiation-warning timer and 3D-specific interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighCPSC·16771·2016-08-31

    Salewa Recalls Wild Country Syncro Climbing Harnesses Due to Fall Hazard

    Salewa North America is recalling Wild Country Syncro climbing harnesses because excess materials on the waist belt tab can cause the harness to loosen, posing a fall hazard.

    Product
    Wild Country Syncro Harnesses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2355-2016·2016-08-31

    Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.

    Product
    INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1971-2016·2016-08-31

    Eatin' Alive Recalls Thai Peanut Noodles for Undeclared Soy Allergen

    Paige Common is recalling 24 units of Eatin' Alive Thai Peanut Noodles sold in Oregon due to undeclared soy.

    Product
    Eatin' Alive VEGAN GLUTEN FREE RAW thai peanut noodles. Keep Refrigerated. 8oz UPC 0 91037 56624 9
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2358-2016·2016-08-31

    Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2356-2016·2016-08-31

    Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results

    Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.

    Product
    Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2639-2016·2016-08-31

    Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighNHTSA·16V631000·2016-08-31

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks is recalling 2015-2017 Thomas Built Buses equipped with certain Ricon wheelchair lifts because pivot holes may allow bearings to move, risking platform failure.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2359-2016·2016-08-31

    Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings

    Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.

    Product
    Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for quantitative d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Defect

    Medtronic Sofamor Danek USA Inc is recalling four units of Alpha total knee replacement femoral components that may not have been passivated according to requirements.

    Product
    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2362-2016·2016-08-31

    Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results

    Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.

    Product
    Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is app
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2016·2016-08-31

    Merge Healthcare Recalls RadSuite Software Due to Image Display Error

    Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.

    Product
    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1949-2016·2016-08-31

    Montana Flour & Grains Recalls Organic Spelt Flour for Undeclared Wheat

    Montana Flour & Grains is recalling 100% Organic Spelt Flour because the label does not declare wheat, a major food allergen.

    Product
    100% Organic Spelt Flour, packaged in 10 lbs., 25 lbs. and 50 lbs paper bags, bulk container.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2016·2016-08-31

    Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination

    Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed worldwide.

    Product
    Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2016·2016-08-31

    Conmed Dual Dispersive Electrodes Recalled for Burn Risk

    Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.

    Product
    Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Food)·F-1974-2016·2016-08-31

    Laxmi Nutkhhata Golden Raisins Recalled for Undeclared Sulfites

    House of Spices is recalling Laxmi Nutkhhata Golden Raisins because they contain undeclared sulfites, a major food allergen.

    Product
    LAXMI NUTKHHAT Golden Raisins, Net Wt. 200g (7 oz), Product of USA -- Distributed by House of Spice Flushing, NY
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2640-2016·2016-08-31

    Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction

    Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.

    Product
    Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2638-2016·2016-08-31

    Medtronic Recalls Alpha Total Knee Replacement Tibial Tray Components

    Medtronic is recalling specific Alpha total knee replacement tibial trays that may not have been passivated according to manufacturing requirements.

    Product
    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
    Category
    Medical Device
    Distribution
    3 states

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