ICU Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0365-2026)

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 ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

Product Classification:

Class II

Date Initiated: September 8, 2025

Date Posted: November 5, 2025

Recall Number: Z-0365-2026

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: 202900 units

Code Information:

Lot:KL-VA001U3: 14360690 14345871 14367719 14381368 14381367; KL-VA002U3: 14345872; KL-VA131U3: 14381373; KL-VA201U3: 14337455 14381355 14381358; KL-VA202U3: 14367718, KL-VA321U3: 14345878 ; Distributed in Japan

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