FDAClass IIJanuary 21, 2026

Portex Spinal Tray recall

Portex Spinal Tray, Item No. A3729-24 A3595

Why was Portex Spinal Tray 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Portex Spinal Tray, Item No. A3729-24 A3595
Recalling firm
ICU Medical Inc.
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.
Recall date
January 21, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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