Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1285-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24

Product Classification:

Class I

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1285-2025

Event ID: 96294

Reason for Recall:

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

Status: Ongoing

Product Quantity: 12 units

Code Information:

UDI/DI 10610586012747, Lot Numbers: 4317077

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated