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.

51–75 of 138

  • 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-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-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-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-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-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-2016-2024·2024-06-12

    FLIXENE Vascular Graft Recalled for Slider Component Separation

    Atrium Medical is recalling the FLIXENE vascular graft due to reported separation of the Slider GDS Swivel Rod from its core. Component separation could affect graft function.

    Product
    FLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2009-2024·2024-06-12

    Vascular graft recalled for swivel rod separation risk

    FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.

    Product
    FLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1985-2024·2024-06-12

    Vascular Graft Swivel Rod Separation Recalled Due to Component Failure

    Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, which could affect device function.

    Product
    ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-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-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·24740·2024-02-22

    Polaris MATRYX Snowmobiles Recalled for Primary Clutch Failure Hazard

    Polaris is recalling Model Year 2022–2024 MATRYX snowmobiles with PATRIOT 650 and 850 engines because the primary clutch can fail and separate from the vehicle, creating an injury hazard. Polaris has received 109 reports of clutch failure, including one incident resulting in a laceration injury.

    Product
    Model Year 2022-2024 MATRYX Snowmobiles equipped with PATRIOT 650 and 850 Engines
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2023·2023-09-13

    Philips 3D9-3v Ultrasound Transducer may separate due to bonding defect

    Philips 3D9-3v Transducer units may separate at the chassis bonding, risking electric shock and tissue damage if safety systems fail. Affected units distributed worldwide.

    Product
    3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1619-2023·2023-05-31

    Medical Device Spine Pack Light Handles May Separate During Surgical Use

    Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.

    Product
    Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1620-2023·2023-05-31

    Aligned Medical Solutions hand pack light covers may separate during use

    Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.

    Product
    Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1494-2023·2023-05-17

    Emboli Capture Guidewire System recalled for component separation risk

    The ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled because the delivery system and capture sheath may separate during procedures, potentially causing stroke or requiring emergency surgical intervention.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2023·2023-05-17

    Emboli Capture Guidewire System Recalled Due to Potential Component Separation

    Cordis US Corp recalls 54 units of the ANGIOGUARD RX/XP Emboli Capture Guidewire System due to potential separation of device components. This could delay procedures or result in unplanned intervention, including possible stroke.

    Product
    ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1431-2023·2023-05-03

    Surgical Convenience Kits Recalled for Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The recall affects 278 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1437-2023·2023-05-03

    Surgical Convenience Kits Recalled Due to Separating Light Handle Covers

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - An
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1433-2023·2023-05-03

    Sterile surgical kit recalled due to light handle cover separation risk

    ROi CPS LLC is recalling sterile surgical convenience kits because light handle covers may separate and fall off during use. Approximately 70 kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1438-2023·2023-05-03

    Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 1,369 sterile surgical convenience kits because light handle covers may separate and fall off during use. The affected kits were distributed nationwide in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1436-2023·2023-05-03

    Sterile surgical C-section kit light handle covers recalled for separation risk

    ROi CPS LLC recalls sterile surgical C-section kits due to light handle covers that may separate and fall during use. The recall affects 1,312 kits distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1435-2023·2023-05-03

    Sterile Surgical Kit Light Handle Covers May Separate During Use

    ROi CPS LLC is recalling 386 sterile surgical convenience kits (WPH GYN Laparoscopy Pack) because light handle covers may separate and fall off during use.

    Product
    Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide