The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

1–100 of 1183

  • SevereCPSC·15204·2015-07-31

    NVIDIA Recalls SHIELD Tablet Computers Due to Fire Hazard

    NVIDIA is recalling approximately 83,000 SHIELD tablet computers because the lithium-ion batteries can overheat and pose a fire hazard.

    Product
    NVIDIA SHIELD tablet computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2015·2015-07-31

    Good Food Made Simple Recalls Turkey and Pork Products Lacking Inspection

    Good Food Made Simple is recalling approximately 3,574 pounds of turkey and pork breakfast products that were distributed in California without U.S. inspection.

    Product
    Good Food Made Simple Recalls Turkey and Pork Products Distributed Without the Opportunity for Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-073115·2015-07-31

    USDA Issues Public Health Alert for Pork Due to Salmonella

    USDA FSIS issued a public health alert for whole pigs used for roasts due to possible Salmonella contamination linked to illness clusters in Washington.

    Product
    FSIS Issues Public Health Alert for Pork Due to Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·105-2015·2015-07-30

    Greenland Trading Corp. Recalls Squab Products Produced Without Import Inspection

    Greenland Trading Corp. is recalling approximately 12,672 pounds of squab products imported from France without U.S. inspection. The recall addresses a potential risk of adverse health consequences due to the lack of full inspection.

    Product
    Greenland Trading Corp. Recalls Squab Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V482000·2015-07-30

    Heartland Recalls Trailers With Inaccurate Tire Certification Labels

    Heartland is recalling various trailer models because tire certification labels may contain inaccurate sizing or inflation information, potentially leading to tire failure.

    Product
    HEARTLAND — HEARTLAND TORQUE, BIG HORN, PROWLER, TRAIL RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V478000·2015-07-30

    Forest River Recalls 160 Motorhomes Due to Back-Up Camera Image Reversal

    Forest River is recalling 160 motorhomes because the back-up camera system may display reversed images, increasing the risk of a crash.

    Product
    STARCRAFT BUS — STARCRAFT BUS, ELKHART, GLAVAL BUS STARLITE, STARQUEST, ECE4, ALLSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15202·2015-07-30

    Nipponflex Recalls Smart Flex and Smart Care Mattresses for Fire Hazard

    Nipponflex is recalling about 400 Smart Flex and Smart Care mattresses because they fail to meet federal flammability standards, posing a fire hazard.

    Product
    Nipponflex Smart Flex and Smart Care mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V480000·2015-07-30

    Forest River Recalls Sandpiper and Sierra RVs for Inaccurate Weight Labels

    Forest River is recalling 2014-2016 Sandpiper and Sierra recreational vehicles because inaccurate gross vehicle weight rating labels could mislead owners about capacity.

    Product
    FOREST RIVER — FOREST RIVER SANDPIPER, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2069-2015·2015-07-29

    Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk

    Western / Scott Fetzer Company is recalling OxyTOTE Portable Oxygen System regulators due to a risk of ignition and rupture of the oxygen cylinder.

    Product
    Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-2111-2015·2015-07-29

    FDA Recalls Sterile Surgical Kits with Compromised Gloves

    The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.

    Product
    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2156-2015·2015-07-29

    FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2136-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·15200·2015-07-29

    Jenn-Air Wall Ovens Recalled for Burn Risk from Roller Rack

    Whirlpool is recalling Jenn-Air wall ovens because the extendable roller rack can unexpectedly disengage, posing a burn risk. Consumers should stop using the rack and contact Whirlpool for a free repair.

    Product
    Jenn-Air Single, Double Wall Ovens and Combination Microwave/Wall Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2195-2015·2015-07-29

    Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

    Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

    Product
    GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2161-2015·2015-07-29

    FDA Recalls Sureflex 910 Lithotripsy Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Sureflex 910 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2138-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil may detach and be left in patients during surgery.

    Product
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2198-2015·2015-07-29

    Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects

    Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2107-2015·2015-07-29

    FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves

    The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2194-2015·2015-07-29

    Philips Gemini LXL CT/PET Systems Recalled for Software Defects

    Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.

    Product
    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2015·2015-07-29

    Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.

    Product
    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2865-2015·2015-07-29

    GloryBee Recalls Turkish Organic Diced Apricots Containing Rocks and Metal

    GloryBee Inc is recalling 107 boxes of Turkish Organic Diced Apricots with Rice Flour due to the presence of rocks and metal.

    Product
    Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net wt. 28 lbs.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2116-2015·2015-07-29

    FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves

    The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.

    Product
    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2857-2015·2015-07-29

    Marine Harvest Recalls Kirkland Signature Fresh Farmed Atlantic Salmon Fillets

    Marine Harvest is recalling Kirkland Signature fresh farmed Atlantic salmon fillets due to potential Listeria monocytogenes contamination.

    Product
    Kirkland Signature Fresh Farmed Atlantic Salmon Fillet Product of Chile Processed in USA approx 2lbs. Packaged in a styrofoam tray and wrapped in plastic.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2174-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2015·2015-07-29

    FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves

    The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2197-2015·2015-07-29

    Philips GEMINI TF Ready CT/PET System Software Defect Recall

    Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.

    Product
    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2137-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2175-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2196-2015·2015-07-29

    Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall

    Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.

    Product
    GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2015·2015-07-29

    GE Healthcare Precision RXi Digital System Monitor Suspension Recall

    GE Healthcare is recalling Precision RXi Digital systems because a monitor fell from its suspension, posing an injury risk to patients or operators.

    Product
    GE Healthcare Precision RXi Digital system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2855-2015·2015-07-29

    La Mexicana Spinach Dip Recalled for Undeclared Milk Allergen

    Pages Produce Company is recalling La Mexicana Spinach Dip because milk is not declared as a sub-ingredient in the sour cream.

    Product
    La Mexicana Spinach Dip Net Wt. 14oz. clear, plastic cup Product is packaged in plastic white container.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2135-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling specific software versions for its s5 and CORE Intravascular Ultrasound Systems because they may calculate inaccurate FFR/iFR values under certain circumstances.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2015·2015-07-29

    FDA Recalls Sterile Single Basin Kits with Compromised Gloves

    The FDA is recalling 77,588 sterile single basin kits because the Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2015·2015-07-29

    Philips Gemini GXL CT/PET System Software Recall for Tumor LOC Defects

    Philips is recalling two Gemini GXL 16 Slice CT/PET systems due to software defects in the Tumor LOC application that may cause incorrect tissue irradiation.

    Product
    GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2189-2015·2015-07-29

    Argon Medical Devices Recalls T-Lok Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling specific T-Lok bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2142-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2119-2015·2015-07-29

    FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise

    The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.

    Product
    Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2856-2015·2015-07-29

    Marine Harvest Recalls Raw Chilean Salmon Due to Listeria Risk

    Marine Harvest is recalling raw, fresh, farmed Chilean Atlantic salmon fillets due to potential Listeria monocytogenes contamination. The affected product was distributed in California, Arizona, and Nevada.

    Product
    Raw, Fresh, Farmed Chilean Atlantic Salmon -Atl Fs Sal Chilean Fill Tr D 3-4 lbs 40lbs -Atl Fs Sal Chilean Fill Deep Skinned Tr E 3-4 lbs 10LBS -Atl Fs Sal Chilean Fill Tr E 3-4 lbs 40lbs -Chilean Fresh Atl Trim D 1-6 Factory 40lbs -Chilean Fresh Atl Factory 1-6 SK off 40lbs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2117-2015·2015-07-29

    FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.

    Product
    NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2015·2015-07-29

    American Catheter Recalls Cholangiogram Catheters Due to Sterilization Seal Failure

    American Catheter Corp is recalling 890 Cholangiogram Catheters because they were not sealed before sterilization. The defect was not detected during acceptance or release activities.

    Product
    American Catheter / Cholangiogram Catheter 9100 Series.
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2199-2015·2015-07-29

    Philips Recalls GEMINI TF Big Bore CT/PET Systems Due to Software Defects

    Philips is recalling 44 GEMINI TF Big Bore CT/PET systems worldwide because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2139-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Su
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2118-2015·2015-07-29

    FDA Recalls Non-Sterile Subassemblies Due to Sterility Compromise

    FDA is recalling specific non-sterile subassemblies from Covidien LLC because they contain splits or holes that compromise sterility.

    Product
    Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2178-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2015·2015-07-29

    FDA Recalls Devon Light Gloves for Sterility Compromising Defects

    The FDA is recalling specific lots of Devon Light Gloves because splits or holes may compromise sterility. The recall affects 559,108 kits distributed worldwide.

    Product
    Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2121-2015·2015-07-29

    GE Healthcare Precision RXi 23A/32A Analog System Monitor Suspension Recall

    GE Healthcare is recalling Precision RXi 23A/32A Analog Systems because a monitor suspension failure could cause a monitor to fall and injure a patient or operator.

    Product
    GE Healthcare Precision RXi 23A/32A Analog System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2015·2015-07-29

    Recall of Sterile Major Kits with Defective Devon Light Gloves

    FDA is recalling sterile Major Kits containing Devon Light Gloves due to splits or holes that compromise sterility.

    Product
    Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2190-2015·2015-07-29

    Mermaid Medical M-Biopsy Coaxial Introducer Needles Recalled for Plastic Debris

    Mermaid Medical A/S is recalling M-Biopsy Coaxial Introducer Needles due to the potential for small plastic pieces to be present in the luer of the cannula.

    Product
    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2144-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to pro
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2188-2015·2015-07-29

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2176-2015·2015-07-29

    FDA Recalls American Medical Systems Fiber Stripper Tools Due to Sterilization Issues

    American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.

    Product
    Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2015·2015-07-29

    ArthroCare Plasma Wand Devices Recalled for Dielectric Specification Failures

    ArthroCare Corporation is recalling 733 EVac 70 XTRA and PROcise EZ View plasma wand devices because they were released without meeting dielectric specifications.

    Product
    EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2140-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient.

    Product
    ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2187-2015·2015-07-29

    FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2143-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2200-2015·2015-07-29

    Philips Pinnacle3 Radiation Treatment Planning Software Recalled for Dose Inconsistency

    Philips is recalling Pinnacle3 Radiation Treatment Planning System software versions 8.0 and 9.0 due to potential dose inconsistencies with density-overridden ROIs.

    Product
    Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2166-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    Fiber Stripper, 273¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2015·2015-07-29

    Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling Volcano s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2132-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5, s5i, and CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2015·2015-07-29

    Hitachi PROBEAT Proton Beam System Recalled for Radiation Delivery Issues

    Hitachi America is recalling three PROBEAT proton beam systems due to potential radiation delivery inconsistencies during system reboots.

    Product
    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2106-2015·2015-07-29

    FDA Recalls Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling sterile Devon Light Gloves because splits or holes compromise their sterility. The recall covers 26,108,946 units distributed worldwide.

    Product
    Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2015·2015-07-29

    Stryker SelectCore Biopsy Device Recalled for Stylet Ejection Risk

    Stryker is recalling 55 units of the SelectCore Variable Throw Biopsy Device because the stylet may eject during use.

    Product
    Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. Fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualita
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2015·2015-07-29

    FDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Sure F!ex reusable laser fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    200¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V476000·2015-07-29

    Ford Recalls 2015 Lincoln MKT Vehicles Missing Second Row Seats

    Ford is recalling 2015 Lincoln MKT vehicles delivered without second-row seats, creating a safety compliance issue and increased crash injury risk.

    Product
    LINCOLN — LINCOLN MKT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2015·2015-07-29

    Biomet Polaris 4.75 TI Spinal System Multiaxial Screws Recalled for Fatigue Strength

    Biomet Spine is recalling 4,765 units of Polaris 4.75 TI Spinal System multiaxial screws because they may not meet internal fatigue strength requirements.

    Product
    Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2015·2015-07-29

    Bausch & Lomb SoFlex SE Intraocular Lens Recall for Haptic Breakage

    Bausch & Lomb is recalling SoFlex SE foldable intraocular lenses because haptics may break during loading and insertion.

    Product
    Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may cause inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2859-2015·2015-07-29

    Golden Plains Recalls Roseli Sundried Tomato Pesto Sauce for Salmonella

    Golden Plains Frozen Foods is recalling Roseli Sundried Tomato Pesto sauce because it tested positive for Salmonella. The product was contained and not distributed to consumers.

    Product
    Roseli Sundried Tomato Pesto sauce. #408744 (Dot Item) , # 627328 (Roseli item),3- 2 lbs tubs (poly) packed in corrugated shipper. Keep Frozen - Thaw under refrigeration.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2202-2015·2015-07-29

    Abbott ARCHITECT c8000 System Recalled for Tubing Leak Risk

    Abbott Laboratories is recalling five ARCHITECT c8000 systems because the tubing may not meet specifications and could leak.

    Product
    ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling two WIZARD2 gamma counters due to a barcode label error that may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2141-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE RP CR Articulation Surface trial instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surf
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-2097-2015·2015-07-29

    Maquet Magnus Hybrid OR Table Column Recalled for Collision Risk

    Maquet is recalling 12 Magnus Hybrid OR Table Columns due to a potential collision risk with the C-arm of the Siemens Artis Zeego Angiography System.

    Product
    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2015·2015-07-29

    American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Fiber Stripper, 365¿m, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2858-2015·2015-07-29

    Marine Harvest Recalls Kirkland Signature Salmon Milano Due to Listeria Risk

    Marine Harvest is recalling Kirkland Signature Salmon Milano with Basil Pesto Butter due to potential Listeria monocytogenes contamination. The product was distributed in California, Arizona, and Nevada.

    Product
    Kirkland Signature Salmon Milano with Basil Pesto Butter approx 1.5 lbs. Packaged in a metal tray with plastic cover.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2112-2015·2015-07-29

    Surgical Kits Recalled Due to Glove Splits Compromising Sterility

    The FDA is recalling 114,813 surgical kits containing Devon Light Gloves due to splits or holes that compromise sterility.

    Product
    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 74
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V474000·2015-07-29

    Harley-Davidson Recalls 2015 XG500 and XG750 Motorcycles for Fuel Pump Defect

    Harley-Davidson is recalling 2015 XG500 and XG750 motorcycles because a poor fuel pump seal may interrupt fuel supply, causing abrupt power restoration and loss of control.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG500, XG750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2120-2015·2015-07-29

    GE Healthcare Precision 500D Monitor Suspension Recall

    GE Healthcare is recalling Precision 500D and related fluoroscopic systems because monitor suspensions may fail, posing a risk of injury to patients or operators.

    Product
    GE Healthcare Precision 500D Classical R & F system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2015·2015-07-29

    Stryker Neptune 2 Waste Management System Recalled for Diverter Valve Failures

    Stryker is recalling the Neptune 2 Waste Management System due to installation failures of the diverter valve assembly during docking.

    Product
    0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-0
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-1271-2015·2015-07-29

    Wockhardt Recalls Metoprolol Succinate Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Metoprolol Succinate Extended-Release Tablets because the firm did not adequately investigate customer complaints.

    Product
    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2185-2015·2015-07-29

    FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1250-2015·2015-07-29

    Wockhardt Recalls Famotodine Tablets Due to CGMP Deviations

    Wockhardt USA Inc. is recalling Famotodine Tablets, USP, 40 mg due to inadequate investigation of customer complaints.

    Product
    Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1264-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA is recalling 7,584 bottles of Azithromycin 600 mg tablets because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2207-2015·2015-07-29

    Siemens Recalls ADVIA Centaur Tni-Ultra Assay Due to System Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Tni-Ultra Assay kits due to system-to-system bias between different ADVIA Centaur platforms.

    Product
    ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2130-2015·2015-07-29

    Perkin Elmer WIZARD2 Gamma Counter Recalled for Barcode Label Error

    Perkinelmer is recalling 179 WIZARD2 gamma counters because a barcode label error may produce erroneous results.

    Product
    Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2181-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, correspond
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1263-2015·2015-07-29

    Wockhardt Recalls Azithromycin Tablets Due to Complaint Investigation Failures

    Wockhardt USA LLC is recalling Azithromycin Tablets, USP, 500 mg because the firm did not adequately investigate customer complaints.

    Product
    Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1275-2015·2015-07-29

    Wockhardt Recalls Captopril Tablets Due to CGMP Deviations

    Wockhardt USA is recalling Captopril Tablets, USP, 25 mg due to inadequate investigation of customer complaints.

    Product
    Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
    Category
    Drug
    Distribution
    Distributed nationwide

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