Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1283-2025)

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, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24

Product Classification:

Class I

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1283-2025

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: 1961 units

Code Information:

UDI/DI 10610586012716, Lot Numbers: 3941279, 3969275, 3984421, 4022601, 4136364, 4148590, 4153873, 4196768, 4227788, 4232310, 4235600, 4248718, 4276227, 4302980, 4307478, 4317093, 4325880, 4358053, 4358054, 4395512, 4415445, 4420760, 4437255, 4449234, 4449877, 4460620, 6013083, 6003891, 6053532, 6062026.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated