FDA Device Recall Z-1286-2025

Smiths Medical ASD, Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Lot / serial / GTIN: UDI/DI 10610586012754, Lot Numbers: 4196769

Quantity: 0 units

Reason for recall

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Recall record

Recall number: Z-1286-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2025-02-13
Classified by FDA Center: 2025-03-18
FDA published: 2025-03-26
Recalling firm: Smiths Medical ASD, Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All device recalls