The Recall Desk

Hazard

Bleeding recalls

177 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
177
Critical
11
Severe
84
Most recent
2026-09-02

Of the 177 bleeding recalls we have scored against our rubric, 11 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 84 (47%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all bleeding recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 177

  • SevereFDA (Devices)·Z-1383-2021·2021-04-21

    FDA Recalls Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired and causing tissue injury.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1286-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheaths

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1287-2021·2021-03-31

    Biosense Webster Recalls CARTO VIZIGO Bi-Directional Guiding Sheath

    Biosense Webster is recalling CARTO VIZIGO Bi-Directional Guiding Sheaths because the hemostatic valve may dislodge, potentially causing minor bleeding or embolism.

    Product
    Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and a
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2763-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2765-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2761-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2764-2020·2020-08-12

    Boston Scientific Recalls Captiflex Snares Due to Potential Cutting Failure

    Boston Scientific is recalling specific lots of Captiflex Snares because they may fail to cut polyps, potentially causing tissue damage or bleeding.

    Product
    Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snares flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide minimal frict
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2039-2020·2020-06-03

    Medtronic Confida Expandable Sheath Recalled for Vascular Complication Risk

    Medtronic is recalling 103 units of the Confida Expandable Sheath due to an increased risk of vascular complications, including bleeding, hematoma, and dissection.

    Product
    Medtronic Confida Expandable Sheath, REF CES122230. To provide a guide for catheters or devices introduced into the femoral iliac arteries.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1865-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1863-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Gold Knitted Microvel Double Velour Vascular Grafts due to potential small holes at the seam lines that may cause intra-operative bleeding.

    Product
    Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1875-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide