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
23
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 23 (17%) 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-1980-2024·2024-06-12

    Vascular Graft Recall for Component Separation in ADVANTA VXT

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could compromise device function.

    Product
    ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. 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-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
  • HighFDA (Devices)·Z-1988-2024·2024-06-12

    Vascular graft component separation risk: ADVANTA VXT slider rod defect

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.

    Product
    ADVANTA VXT, 8X70, 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-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-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-1965-2024·2024-06-12

    Vascular Graft Recall Due to Swivel Rod Separation

    Atrium Medical is recalling the ADVANTA VXT vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This component separation could affect device function.

    Product
    ADVANTA VXT, 6X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1956-2024·2024-06-12

    Vascular Graft Slider Component May Separate from Core

    Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide after reports of the slider swivel rod separating from the swivel core with a notable gap between components.

    Product
    ADVANTA VXT, 7X50, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1961-2024·2024-06-12

    Vascular Graft Recalled Due to Slider Component Separation Risk

    Atrium Medical's ADVANTA VXT vascular grafts are recalled due to reported separation of the slider component from the swivel core. Over 53,000 units worldwide may be affected.

    Product
    ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2024·2024-06-12

    Vascular graft component separation risk prompts medical device recall

    Atrium Medical Corporation recalled FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units are affected worldwide.

    Product
    FLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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…
    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-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
  • 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
  • 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-1432-2023·2023-05-03

    Sterile Surgical Kits Recalled Due to Light Handle Cover Separation Risk

    ROi CPS LLC is recalling 662 sterile surgical convenience kits because light handle covers may separate from the light handle and fall off during use. The kits were distributed in Florida and Missouri.

    Product
    Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E…
    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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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