The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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25801–25825 of 40233

  • HighFDA (Devices)·Z-2871-2017·2017-08-16

    Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip

    Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.

    Product
    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2017·2017-08-16

    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, 3 CC L/L 22 G X 1.0, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2897-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance

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

    Product
    PALLAS M/MAXIMIS Set 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 spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2017·2017-08-16

    C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach

    C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.

    Product
    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2017·2017-08-16

    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 product's sterility claims.

    Product
    Hypodermic Needle, 20 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
  • HighFDA (Devices)·Z-2821-2017·2017-08-16

    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 product sterility claims.

    Product
    Hypodermic Needle, 27 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
  • HighFDA (Devices)·Z-2910-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.

    Product
    PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 21 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
  • HighFDA (Devices)·Z-2898-2017·2017-08-16

    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 FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. 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
  • HighFDA (Devices)·Z-2813-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

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

    Product
    Hypodermic Needle, 21 G X 1.5 in YALE DISP, 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-2815-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support its product sterility claims.

    Product
    Hypodermic Needle, 22 G X 1.5 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-2932-2017·2017-08-16

    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 FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 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-2807-2017·2017-08-16

    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, 18 G X 1.5 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-2933-2017·2017-08-16

    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 5.5 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-2886-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 50mm MIS Rods for Quality Issues

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

    Product
    PALLAS M/MAXIMIS 50mm 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-2843-2017·2017-08-16

    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 sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 5 CC L/L 22 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-2959-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS 400mm Straight Rods

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 400mm Straight Rods because they are not consistent with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 400mm 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-2940-2017·2017-08-16

    Valorem Surgical Recalls Pallas M 35mm Curved Rods for Quality Issues

    Valorem Surgical is recalling 2,225 Pallas M 35mm Curved Rods because they do not meet FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS 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-2930-2017·2017-08-16

    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 6.5 x 55mm and 6.5 x 5.5 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-2989-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Extension Guide Bushes for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Extension Guide Bush. 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-2844-2017·2017-08-16

    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, 10 CC L/L 20 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-2947-2017·2017-08-16

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

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

    Product
    PALLAS M/MAXIMIS 35mm 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-2968-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Spinal Fixation Devices

    Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Anti Torque devices due to non-compliance with Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Anti Torque. 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-2809-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

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

    Product
    Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2993-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Anti Torque Devices for Quality Issues

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

    Product
    PALLAS M/MAXIMIS Anti Torque Device. 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