The Recall Desk

FDA (Devices) recall action 91849

Stryker Corporation recalled 6 products on 2023-04-12

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2023-04-12
Critical
0
Units
—

Why these products were recalled

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

The agency’s own wording, quoted from the enforcement report.

1–6 of 6

  • HighFDA (Devices)··2023-04-12

    Stryker Tourniquet Cuff May Fail to Hold Pressure During Surgery

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or hold pressure during initial surgical setup. This failure could allow blood to flow from the surgical site, potentially causing hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery

    Stryker tourniquet cuffs may fail to maintain proper pressure during initial setup, potentially causing operative blood loss or hemorrhage during surgical procedures.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-04-12

    Stryker Color Cuff Tourniquet Cuff pressure failure recall

    Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss

    Stryker's non-sterile disposable tourniquet cuff may fail to achieve or maintain proper pressure during surgical setup, potentially causing blood loss or hemorrhage. Approximately 1,979 units distributed nationwide are affected.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-04-12

    Stryker Disposable Tourniquet Cuff Recalled for Pressure Regulation Failure

    Stryker recalled 1,617 units of a disposable tourniquet cuff that may fail to achieve or hold pressure during surgery, potentially causing blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2023-04-12

    Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding

    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
    Category
    Distribution
    0 states
Stryker Corporation recalled 6 products on 2023-04-12 · The Recall Desk