The Recall Desk

Hazard

Catheter Leakage recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-10-12

Of the 4 catheter leakage recalls we have scored against our rubric, 0 (0%) 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 leakage 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.

1–4 of 4

  • HighFDA (Devices)·Z-0009-2023·2022-10-12

    Introcan Safety Catheter Recalled for Potential Leakage at Hub

    B. Braun is recalling 94,000 Introcan Safety FEP 14G catheters due to potential leakage at the catheter hub. Affected units were distributed in the US and Canada.

    Product
    Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0066-2022·2021-10-13

    Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

    Product
    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2022·2021-10-13

    Zoll Cool Line IV Disposable Pack Recalled for Potential Leakage Risk

    ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.

    Product
    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2340-2021·2021-09-01

    Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide

    W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.

    Product
    Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
    Category
    Medical Device
    Distribution
    Distributed nationwide