The Recall Desk

Hazard

Catheter recalls

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

What the numbers show

Total
7
Critical
4
Severe
0
Most recent
2025-09-17

Of the 7 catheter recalls we have scored against our rubric, 4 (57%) 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 catheter 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.

1–7 of 7

  • 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
  • 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
  • CriticalFDA (Devices)·Z-2482-2025·2025-09-10

    Left heart vent catheters recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2481-2025·2025-09-10

    Left heart vent catheters 10FR recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12110, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 41,200 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2480-2025·2025-09-10

    Left heart vent catheters 13FR recalled because they may not retain shape

    DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2460-2025·2025-09-03

    Reprocessed electrophysiology catheters recalled over small residual particulates in specific lots

    Medline ReNewal reprocessed St. Jude Medical diagnostic electrophysiology catheters are recalled because specific lots may contain small residual particulates. The FDA classified the action as Class I.

    Product
    Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2025·2025-09-03

    Foley catheters recalled because obstructed lumen may prevent bladder drainage

    Bardex Lubri-Sil I.C. Foley catheters and related tray systems are recalled because the catheter may have an obstructed lumen, which may prevent the bladder from draining. 175,158 units are affected.

    Product
    Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and
    Category
    Medical Device
    Distribution
    Distributed nationwide