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Recall Observatory FDA recall evidence

Device product

Portex Spinal Tray, Item No. A3729-24 A3595

Z-1101-2026

December 19, 2025

Class II

Product summary

Firm
ICU Medical Inc.
Event
Event 98168
Status
Ongoing
Classification
Class II
Quantity
64290 total
Official record key
device-enforcement:Z-1101-2026

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.