Smiths Medical ASD, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1287-2025)

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, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24

Product Classification:

Class I

Date Initiated: February 13, 2025

Date Posted: March 26, 2025

Recall Number: Z-1287-2025

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: 8515 units

Code Information:

UDI/DI 10610586012778, Lot Numbers: 3916028, 3969277, 4006477, 4022602, 4036895, 4057818, 4060894, 4096338, 4108453, 4114117, 4146468, 4153874, 4163556, 4196775, 4221727, 4235565, 4235567, 4235601, 4248694, 4256927, 4256928, 4256964, 4276228, 4294894, 4294895, 4364693, 4366695, 4366696, 4378523, 4382349, 4392370, 4395513, 4405010, 4420761, 4426418, 4434230, 4453606, 4468579, 4468580, 6005957, 6005958, 6026650, 6026651, 6037122, 6037124, 6051325.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated