The Recall Desk

Hazard

Bleeding Risk recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2025-10-08

Of the 5 bleeding risk recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 risk 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.

1–5 of 5

  • HighFDA (Devices)·Z-0036-2026·2025-10-08

    Vascular grafts recalled after delamination reports prompt instructions for use update

    W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.

    Product
    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1514-2024·2024-04-17

    PEG Feeding Tube Kit Recalled for Blocked Lumen Preventing Guidewire Advancement

    Boston Scientific is recalling 572 EndoVive PEG feeding tube kits due to a blocked lumen in the barb connector that may prevent guidewire advancement during placement, potentially requiring device exchange and increasing risk of complications.

    Product
    EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2024·2024-02-07

    Endoscopic Surgical Stapler Reload May Fail to Form Complete Staple Line

    An endoscopic surgical stapler reload may fail to properly form staples during use, potentially leaving tissue inadequately sealed. This could lead to bleeding or require additional surgery.

    Product
    ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2024·2024-01-17

    Olympus ENDOEYE HD II Videoscope Image Discoloration Recall

    Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.

    Product
    Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the tho
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2022·2021-11-24

    LEEP PRECISION Generator 120V Hand Switch Coagulation Function Failure

    CooperSurgical is recalling 244 LEEP PRECISION Generator 120V units because the hand switch's coagulation function may fail to operate properly, potentially requiring medical intervention to control bleeding during surgical procedures.

    Product
    LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
    Category
    Medical Device
    Distribution
    Distributed nationwide