The Recall Desk

Hazard

Tyvek Puncture 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
2025-07-16

Of the 4 tyvek puncture 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 tyvek puncture 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-2105-2025·2025-07-16

    VersaCross transseptal sheath kits may have a punctured sterile barrier pouch

    VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2025·2025-07-16

    Torflex transseptal guiding sheath kits may have a punctured sterile pouch

    Torflex Transseptal Guiding Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2104-2025·2025-07-16

    VersaCross RF wire lots may have a punctured sterile barrier pouch

    The VersaCross RF Wire is being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units are affected.

    Product
    VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2025·2025-07-16

    VersaCross access kits may have a hole in the sterile pouch

    VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.

    Product
    VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
    Category
    Medical Device
    Distribution
    Distributed nationwide