The Recall Desk

Archive

August 2017 recalls

1,004 recalls were announced in August 2017.

What the numbers show

Critical
75
Severe
178
High
462
Moderate
267
Low
22

Of the 1,004 recalls this month scored against our rubric, 7% are Critical, 18% are Severe.

Which agencies issued them

601–700 of 1004

  • ModerateFDA (Devices)·Z-2891-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 35mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2854-2017·2017-08-16

    International Medsurg Piston Syringes Recalled for Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2955-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 35mm Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 35mm Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2944-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 60mm Spinal Fixation Rods

    Valorem Surgical LLC is recalling 2,225 units of Pallas M/MAXIMIS 60mm curved and precontoured rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2849-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3359-2017·2017-08-16

    ISABEL Octopus in Garlic Sauce Recalled for Mislabeling as Squid

    ISABEL North America is recalling Octopus in Garlic Sauce because the label states Octopus but the actual content is Squid.

    Product
    ISABEL, Octopus in garlic sauce, Pulpo al ajillo, Net wt - Peso Neto 4 oz(115g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2884-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 40mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm MIS rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 40mm MIS rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2819-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2935-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2957-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 40mm Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 40mm Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Spinal Fixation Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2840-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2903-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 6.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2888-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 70mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm MIS Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2839-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles nationwide because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2965-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Poly Screw Driver for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Poly Screw Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3010-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS C. Spinal Fixation Probes

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS C. probes used in spinal fixation systems because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2953-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 80mm Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2951-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 60mm Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 60mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2911-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Polyaxial and MIS Screw, 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2999-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Alignment Drivers

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Alignment Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2992-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Poly Screw Drivers for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Poly Screw Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2941-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2912-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1060-2017·2017-08-16

    AtHome Medical Recalls Liquid Oxygen Due to GMP Deviations

    AtHome Medical, Inc. is recalling 80 lbs of Oxygen Refrigerated Liquid USP due to a lack of standard operating procedures for testing out-of-specification products.

    Product
    Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2981-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Cut Devices for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MIS Pedicle Cut devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2927-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Defects

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2846-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles nationwide because of insufficient documentation to support sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2979-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Dilator A Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Dilator A due to quality system non-compliance. The devices are used for spinal fixation.

    Product
    PALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2829-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because documentation supporting sterility claims is insufficient.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 20 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2994-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Nut Drivers for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2983-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 6.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS MIS Tapper 6.5mm devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2906-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 7.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3355-2017·2017-08-16

    Duy Drugs Recalls Viva ben Femenine Supplement for CGMP Violations

    Duy Drugs Inc. is recalling 1,800 bottles of Viva ben Femenine Supplement because the product failed to meet current good manufacturing practices (CGMPs) for identity, purity, and composition.

    Product
    Viva ben Femenine Supplement, Dietary Supplement 30 Softgels
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2874-2017·2017-08-16

    Valorem Surgical Recalls Pallas M 50mm Curved Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 50mm Curved Rods because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 50mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 units of piston syringes and hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 7.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2904-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Poly Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2823-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2998-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Compressor and Rod Tightener

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS MISS/MIS Compressor and Rod Tighteners because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2817-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling hypodermic needles because the company lacks documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2991-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Compass Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Compass devices because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3001-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Pusher for Quality System Issues

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS Rod Pusher Angled because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2842-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2909-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3002-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Torque Handles for Quality System Issues

    Valorem Surgical is recalling 262 Pallas M/MAXIMIS Torque Handles because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-201·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3356-2017·2017-08-16

    Duy Drugs Recalls Cardiovid Plus Dietary Supplement for CGMP Violations

    Duy Drugs Inc. is recalling 411 bottles of Cardiovid Plus dietary supplements because they failed to meet FDA current good manufacturing practice requirements.

    Product
    Cardiovid Plus, Cardiovascular Active Dietary Supplement, 60 Softgels
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2822-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million hypodermic needles because documentation supporting their sterility claims is insufficient.

    Product
    Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2946-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 80mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 80mm Curved Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3358-2017·2017-08-16

    ISABEL Octopus in Marinera Sauce Recalled for Mislabeling as Squid

    ISABEL North America is recalling Octopus in marinera sauce because the label states Octopus but the actual content is Squid.

    Product
    ISABEL, Octopus in marinera sauce, Pulpo en salsa marinera, Net wt - Peso Neto 4 oz(115g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2880-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Curved Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 5.5 x 35mm Curved Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2824-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2915-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm and 6.5 x 4.5 screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2895-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 60mm MIS Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 60mm MIS Rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2975-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screw Fixation Components

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Reduction A components due to quality system non-compliance.

    Product
    PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2857-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 piston syringes nationwide because documentation supporting their sterility claims is insufficient.

    Product
    Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2977-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Cross Link Torque Handles

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Cross Link Torque Handles because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2970-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Compressor for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Compressors because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2894-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 55mm MIS Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 55mm MIS Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 55mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1059-2017·2017-08-16

    X-Gen Recalls Nystatin Topical Powder Due to Potential Plastic Particles

    X-Gen Pharmaceuticals is recalling Nystatin Topical Powder due to the potential presence of plastic particles. The recall covers 9,816 bottles distributed nationwide.

    Product
    Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2907-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3006-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Tapper for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MISS/MIS Tapper 7.5 mm due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2954-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Spinal Fixation Rods

    Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 250mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2966-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Nut Drivers for Quality Issues

    Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2919-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Screw 7.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2841-2017·2017-08-16

    FDA Recalls Piston Syringes Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because the company lacks documentation to support the products' sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2958-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 350 Straight Rods for Quality Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 350 Straight Rods because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3017-2017·2017-08-16

    Elekta Recalls iGUIDE Software 2.2 Due to Incorrect PEC Values

    Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.

    Product
    iGUIDE Software 2.2 Product Usage: Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2982-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS MIS Tapper 5.5mm Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2995-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Bender for Quality System Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements. The devices are used for spinal fixation.

    Product
    PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Rod Bender for Quality Issues

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2816-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54.2 million hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2945-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 70mm Curved Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Curved Rods due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1058-2017·2017-08-16

    Teva Recalls Glipizide Extended-Release Tablets Due to Moisture Limit Failures

    Teva Pharmaceuticals USA is recalling 2,880 cartons of Glipizide Extended-Release Tablets, 5 mg, because stability testing revealed out-of-specification water content.

    Product
    Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg, packaged in 30-unit dose blister pack per carton, Rx only, Mfd for: Watson Laboratories, Inc., Corona, CA 92880, Mfd by: Patheon Pharmaceuticals, Inc., Cincinnati, OH 43215, NDC 0591-0844-15
    Category
    Drug
    Distribution
    6 states
  • HighCPSC·17207·2017-08-15

    BRIO Recalls Soft Hammer Baby Rattles Due to Choking Hazard

    BRIO is recalling soft hammer baby rattles because wooden rings can crack, posing a choking hazard to children. No injuries have been reported.

    Product
    BRIO soft hammer rattles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17206·2017-08-15

    Laura Ashley Girl's Dresses Recalled Due to Choking Hazard

    Pastourelle is recalling Laura Ashley girl's dresses because flower petals can detach, posing a choking hazard to children.

    Product
    Girl's dresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·093-2017·2017-08-15

    Missa Bay Recalls Chicken Caesar Salad Due to Undeclared Wheat Allergen

    Missa Bay LLC is recalling chicken caesar salad products because they contain wheat, a known allergen, that is not declared on the label.

    Product
    Missa Bay LLC — Missa Bay, LLC Recalls Chicken Products Due To Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·17V505000·2017-08-14

    Keystone Recalls 2018 Crossroads Trailers Due to Propane Line Fire Risk

    Keystone RV is recalling 2018 Crossroads Redwood and Cameo trailers because the propane manifold may contact the floor, potentially damaging the line and causing a leak that increases fire risk.

    Product
    CROSSROADS — CROSSROADS CAMEO, REDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V502000·2017-08-14

    BMW Recalls 2014-2017 R NINE T Motorcycles for Swingarm Bolt Issue

    BMW is recalling 2014-2017 R NINE T motorcycles because swingarm pivot pin bolts may loosen, increasing crash risk. Dealers will repair the issue free of charge.

    Product
    BMW — BMW R NINE T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V506000·2017-08-14

    Mercedes-Benz Recalls AMG GLE43 Vehicles Due to Engine Shutdown Risk

    Mercedes-Benz is recalling 2016-2017 AMG GLE43 vehicles because software conflicts may cause the engine to shut down while driving, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V406000·2017-08-14

    2018 International LT and HX Trucks Recalled for Fuel Pump Defect

    Navistar is recalling 2018 International LT and HX trucks because a fuel pump gear may slip, causing engine stalls that increase crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL LT, HX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V504000·2017-08-14

    KME Predator Aerial Vehicles Recalled for Ladder Speed Software Error

    KME is recalling 2012-2017 Predator Aerial vehicles because a software error may cause the ladder to accelerate unexpectedly, increasing injury risk.

    Product
    KME — KME PREDATOR SS AERIAL, PREDATOR AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·092-2017·2017-08-12

    Luvo Recalls Poultry Products Due to Misbranding and Undeclared Allergens

    Luvo Inc. is recalling approximately 4,805 pounds of mislabeled poultry products containing undeclared allergens. The products were distributed to 11 states.

    Product
    Luvo Inc. (USA) Recalls Poultry Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    11 states
  • SevereNHTSA·17V500000·2017-08-10

    Forest River Berkshire Recall: Battery Cable Fire Risk

    Forest River is recalling 2016-2017 Berkshire vehicles because an improperly installed battery cable bracket may cause chafing and short circuits, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V499000·2017-08-10

    AEV Recalls Modified RAM 2500 and 3500 Trucks Due to Wheel Fracture Risk

    Streetcar ORV LLC is recalling 2013-2017 RAM 2500 and 3500 trucks modified with specific cast aluminum wheels that may fracture, causing rapid air loss and potential loss of vehicle control.

    Product
    RAM — RAM 2500, 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V498000·2017-08-10

    Temsa Recalls 2014-2018 TS45 Buses Due to Steering Hose Leak Risk

    Temsa is recalling 2014-2018 TS45 coach buses because the tag axle steering hydraulic hose may leak or burst, potentially causing loss of control or fire.

    Product
    TEMSA — TEMSA TS45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17204·2017-08-10

    Kawasaki Recalls All-Terrain Vehicles Due to Fuel Leak Fire Hazard

    Kawasaki is recalling approximately 15,000 KFX50 and KFX90 all-terrain vehicles because a leaking fuel tap poses a fire hazard. No injuries have been reported.

    Product
    All-terrain vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3346-2017·2017-08-09

    Woodstock Farms Recalls Cranberry Mix Due to Listeria Risk

    Woodstock Farms is recalling Wholesome Pantry Cape Cod Cranberry Mix because a supplier found Listeria monocytogenes in their facility.

    Product
    Wholesome Pantry Cape Cod Cranberry Mix 8oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2961-2017·2017-08-09

    Clif Builders Chocolate Mint Bars Recalled for Undeclared Peanuts and Tree Nuts

    Clif Bar & Company is recalling Clif Builders Chocolate Mint bars due to undeclared peanuts and/or tree nuts. The recall covers multiple pack sizes distributed nationwide and internationally.

    Product
    Clif Builders Chocolate Mint 12-count, 6-pack, 7-pack, Snack Size 200-count
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3341-2017·2017-08-09

    Woodstock Farms Recalls Cascade Trail Mix Due to Listeria Risk

    Woodstock Farms is recalling Natures Promise Cascade Trail Mix because a supplier found Listeria monocytogenes in their facility.

    Product
    Natures Promise Cascade Trail Mix 12oz.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2964-2017·2017-08-09

    Primavera Nueva Tamales Recalled for Undeclared Milk Allergen

    Primavera Nueva is recalling Black Beans Bonanza Tamales because they contain undeclared milk. Consumers with milk allergies should not eat the product.

    Product
    Black Beans Bonanza Tamales with black beans. No Dairy:
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-3347-2017·2017-08-09

    Woodstock Farms Organic Trail Mix Recalled Due to Listeria Risk

    Woodstock Farms is recalling Wholesome Pantry Organic Trail Mix 8oz. because a supplier found Listeria monocytogenes in their facility.

    Product
    Wholesome Pantry Organic Trail Mix 8oz.
    Category
    Food
    Distribution
    0 states

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