The Recall Desk

Hazard

Particulate Migration 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
1
Most recent
2025-09-17

Of the 5 particulate migration recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) 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 particulate migration 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-2534-2025·2025-09-17

    Encore Advantage kits recalled over particles migrating from the inflation device

    Boston Scientific Encore Advantage Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 68,347 units are affected.

    Product
    Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2536-2025·2025-09-17

    UroMax Ultra kits recalled over particles migrating from the inflation device

    Boston Scientific UroMax Ultra Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 1,369 units are affected.

    Product
    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2533-2025·2025-09-17

    Encore 26 inflation devices recalled over foreign material particles migrating into catheters

    Boston Scientific Encore 26 Inflation Devices are recalled because foreign material particles could migrate from the device into a balloon dilatation catheter during use. 39,739 units are affected.

    Product
    Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2535-2025·2025-09-17

    NephroMax kits recalled because inflation device particles may enter balloon catheters

    Boston Scientific NephroMax Kits are recalled because foreign material particles could migrate from the Encore 26 Inflation Device into a balloon dilatation catheter. 458 units are affected.

    Product
    Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0085-2014·2013-11-13

    Baylis Medical Recalls TorFlex Transseptal Guiding Sheath Kits

    Baylis Medical is recalling TorFlex Transseptal Guiding Sheath Kits because the sheath may remove particulate from the dilator, which could migrate into a patient's bloodstream.

    Product
    Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide