Portex Spinal Tray, Item No. A3729-24 A3595
FDA Recall #Z-1101-2026 — Class II — December 19, 2025
Product Description
Portex Spinal Tray, Item No. A3729-24 A3595
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.
Recalling Firm
ICU Medical Inc. — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
64290 total
Distribution
US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
Code Information
1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated