ICU Medical Inc. recalls Portex Spinal Tray, Item No. A3729-24 A3595

Recall date

December 19, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1101-2026

FDA classification

Class II

Brand / firm

ICU Medical Inc.

Sold / distributed

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

Why it was recalled

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Portex Spinal Tray, Item No. A3729-24 A3595