Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1288-2025)

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 Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24

Product Classification:

Class I

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1288-2025

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: 2236 units

Code Information:

UDI/DI 10610586012839, Lot Numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated