The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

33001–33025 of 50502

  • HighFDA (Devices)·Z-1352-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Windstone Medical Packaging is recalling Opgrande Hand Packs containing Medtronic gloves due to potential splits or holes that may compromise sterility.

    Product
    Opgrande Hand Pack, part number AMS4767
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1369-2017·2017-03-08

    Windstone Medical Packaging Recalls Shoulder Packs with Defective Gloves

    Windstone Medical Packaging is recalling 875 Shoulder Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.

    Product
    Shoulder Pack, part number AMS2936 Shoulder Pack, part number AMS3638 Shoulder Pack, part number AMS3711(B Shoulder Pack, part numbere AMS4212 Shoulder Pack, part number AMS6460 Shoulder Pack, part numberPSS1852(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1255-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A Kits due to a negative bias in FT4 assays and potential calibration failures on certain systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2017·2017-03-08

    Windstone Medical Recalls Anterior Cervical Fusion Packs Due to Sterility Risk

    Windstone Medical Packaging is recalling 51 Anterior Cervical Fusion Packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.

    Product
    Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1304-2017·2017-03-08

    Windstone Medical Recalls General Laparoscopy Packs Due to Sterility Concerns

    Windstone Medical Packaging is recalling 36 General Laparoscopy Packs because the disposable gloves included may have splits or holes that compromise sterility.

    Product
    General Laparoscopy Pack, part number AMS4798 General Laparoscopy Pack, part number AMS4798(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1559-2017·2017-03-08

    Gamay Foods Recalls Cheddar Cheese Seasoning Due to Salmonella Concerns

    Gamay Foods Inc is recalling Original Cheddar Cheese Seasoning because a milk powder ingredient was recalled for potential Salmonella contamination.

    Product
    Original Cheddar Cheese Seasoning, #117059, Net Weight 1600 lbs. bulk tote
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1295-2017·2017-03-08

    Windstone Medical Recalls Extremity Packs Due to Potential Sterility Compromise

    Windstone Medical Packaging is recalling 810 Extremity Packs because the disposable gloves inside may contain splits or holes that compromise sterility.

    Product
    Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1267-2017·2017-03-08

    Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

    Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.

    Product
    Basic Pack, part number AMS1868(B Basic Pack, part number AMS2608(A Basic Pack, part number AMS3861 Basic Pack, part number AMS4309 Basic Pack, part number PSS1833 Basic Pack, part number PSS1833(A Basic Pack, part number PSS1848(A
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1392-2017·2017-03-08

    Cook Inc. Recalls Check-Flo Introducer Devices Due to Blood Loss Reports

    Cook Inc. is recalling 29 Check-Flo Introducer Hausdorf-Lock Atrial devices worldwide due to increased reports of blood loss associated with the hemostatic valve design.

    Product
    Check-Flo Introducer Hausdorf-Lock Atrial, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1276-2017·2017-03-08

    Windstone Medical Packaging Recalls Breast Augmentation Kits Due to Sterility Concerns

    Windstone Medical Packaging is recalling 1,436 breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.

    Product
    Breast Augmentation Pack, part number AMS1786(A Breast Augmentation Pack, part number AMS2790(A Breast Augmentation Pack, part number AMS3324(B Breast Augmentation Pack, part number AMS4382 Breast Augmentation Pack, part number AMS4382(A Breast Augmentation Pack, part…
    Category
    Medical Device
    Distribution
    26 states