ICU Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0358-2026)

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:

ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

Product Classification:

Class II

Date Initiated: September 8, 2025

Date Posted: November 5, 2025

Recall Number: Z-0358-2026

Event ID: 97583

Reason for Recall:

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Status: Ongoing

Product Quantity: 2450 units

Code Information:

Lot:14393168, 14414091; Distributed in Canada

Distribution Pattern:

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated