Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1278-2025)

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, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24

Product Classification:

Class I

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1278-2025

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: 643 units

Code Information:

UDI/DI 10610586012532, Lot Numbers: 3968088, 4052396, 4063411, 4101698, 4122782, 4219344, 4232319, 4235596, 4242786, 4317072, 4325879, 4397749, 4420759, 4445594, 4449874.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated