The Recall Desk

Hazard

Component Separation recalls

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

What the numbers show

Total
138
Critical
0
Severe
21
Most recent
2025-04-24

Of the 138 component separation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (15%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all component separation 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 138

  • HighFDA (Devices)·Z-2003-2024·2024-06-12

    FLIXENE Vascular Graft Recall Due to Swivel Rod Component Separation

    Atrium Medical recalls FLIXENE vascular grafts due to complaints of the Slider GDS Swivel Rod separating from the Swivel Core. Component separation in implanted vascular grafts could compromise device function.

    Product
    FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2024·2024-06-12

    Vascular Graft Component Separation Risk Triggers Worldwide Device Recall

    Atrium Medical recalls FLIXENE vascular grafts due to reported separation of the Swivel Rod from the Swivel Core, creating gaps that could affect device function. Over 53,000 units worldwide are affected.

    Product
    FLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1977-2024·2024-06-12

    Vascular graft slider component separation reported in ADVANTA VXT

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units affected worldwide.

    Product
    ADVANTA VXT, 6X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2024·2024-06-12

    FLIXENE Vascular Graft Slider Rod Separation Defect Recall

    Atrium Medical Corporation has recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the pieces.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2024·2024-06-12

    Vascular graft recalled for reported swivel rod separation from core

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of the swivel rod separating from the swivel core. Patients and healthcare providers should contact the manufacturer for guidance.

    Product
    ADVANTA VXT, 8X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2024·2024-06-12

    Vascular graft devices subject to swivel rod separation from core assembly

    Atrium Medical Corporation is recalling ADVANTA VXT vascular graft devices due to reports of the swivel rod separating from the core. The separation could compromise device function.

    Product
    ADVANTA VXT, 6X100, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2024·2024-06-12

    ADVANTA VXT Vascular Grafts Recalled for Slider Rod Separation

    Atrium Medical is recalling 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the slider rod from the swivel core, with a gap observed between the components.

    Product
    ADVANTA VXT, 6X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2024·2024-06-12

    Vascular graft slider component may separate from core

    Atrium Medical's ADVANTA VXT vascular graft may experience separation of the slider mechanism from its core, affecting over 11,000 US units. No injuries have been reported.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2024·2024-06-12

    Vascular Graft Device Recalled for Slider Rod Separation Risk

    Atrium Medical Corporation is recalling approximately 53,308 FLIXENE vascular graft units worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, creating gaps that could affect device performance.

    Product
    FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2024·2024-06-12

    Vascular Graft Swivel Component Separation Recall Affects Thousands Nationwide

    FDA recalls FLIXENE vascular grafts after complaints that the swivel rod separates from the swivel core. The defect affects over 53,000 units distributed worldwide.

    Product
    FLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2024·2024-06-12

    Vascular Graft Component Separation Recall: ADVANTA VXT Slider

    Atrium Medical recalls ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. The defect affects 53,308 units distributed worldwide.

    Product
    ADVANTA VXT, 6X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2024·2024-06-12

    Vascular graft device recalled due to swivel rod separation

    Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the swivel rod from the core component. This defect could compromise device function.

    Product
    FLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1957-2024·2024-06-12

    Vascular graft recalled due to slider component separation risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider GDS swivel rod separating from the swivel core. Approximately 53,308 units are affected worldwide.

    Product
    ADVANTA VXT, 8X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Component Separation Recall

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the slider rod from its core component. This mechanical failure could compromise device functionality.

    Product
    ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2024·2024-06-12

    ADVANTA VXT Vascular Graft Slider Component Separation Recall

    Atrium Medical Corporation is recalling its ADVANTA VXT vascular graft due to reports that the Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1960-2024·2024-06-12

    Vascular graft devices recalled due to slider component separation

    Atrium Medical is recalling ADVANTA VXT vascular grafts following complaints of separation between the slider component and swivel core.

    Product
    ADVANTA VXT, 7X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2024·2024-06-12

    Vascular graft component separation reported in Advanta VXT devices

    Atrium Medical Corporation recalls Advanta VXT vascular grafts due to separation of internal swivel components. Approximately 53,308 units worldwide are affected, with the slider GDS swivel rod potentially separating from its core.

    Product
    ADVANTA VXT, 6X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2024·2024-06-12

    Vascular Graft Swivel Rod Separation Reported in ADVANTA VXT Devices

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reported separation of the slider swivel rod from its core, creating a gap between components. No injuries reported.

    Product
    ADVANTA VXT, 4-7X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2024·2024-06-12

    Vascular graft component separation reported in ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. No injuries have been reported.

    Product
    ADVANTA VXT, 4-6X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2024·2024-06-12

    Vascular Graft Recalled Due to Potential Component Separation Risk

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.

    Product
    ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1995-2024·2024-06-12

    Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT

    Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.

    Product
    ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2024·2024-06-12

    FDA Recalls Atrium Medical Vascular Graft for Slider Separation Defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of the slider rod separating from the swivel core, which could impair proper device function.

    Product
    ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2024·2024-06-12

    Vascular graft separation issue prompts FDA recall of Atrium Medical ADVANTA VXT units

    Atrium Medical Corporation is recalling its ADVANTA VXT vascular grafts due to complaints of swivel rod separation from the swivel core, which could affect device function and patient safety.

    Product
    ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2024·2024-06-12

    Vascular graft device recalled for swivel component separation

    Atrium Medical recalls ADVANTA VXT vascular grafts due to reports of the Slider GDS Swivel Rod separating from the Swivel Core. The internal component separation could compromise device function.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1974-2024·2024-06-12

    Vascular graft component separation in Atrium Medical ADVANTA VXT devices

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts worldwide due to reports of separation between the swivel rod and swivel core. The component failure could affect graft function.

    Product
    ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide