Portex Spinal Tray recall (ICU Medical Inc.)

Medical deviceClass IIOngoing

Summary: ICU Medical Inc. is recalling Portex Spinal Tray, Item No. A3729-24 A3595. 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.

What is being recalled

Portex Spinal Tray, Item No. A3729-24 A3595

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA. (states named: California, Florida, Illinois, Indiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Texas, Washington)

How to tell if yours is affected

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

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from ICU Medical Inc. · all medical device recalls · recalls from December 2025

Official FDA record