Class IIReported 2026-01-21

Portex Spinal Tray, Item No. A3729-24 A3595

Recalled by ICU Medical Inc.

Reason for Recall

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.

Recall Number

Z-1101-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-19

Reported

2026-01-21

Distribution

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

Code Info

1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.