ICU Medical Inc. recalls Portex Spinal Tray
- Recalling company
- ICU Medical Inc.
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 19, 2025
- Reported
- Jan 21, 2026
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.
- Status
- Ongoing
- Quantity
- 64290 total
- Lot / codes
- 1. A3729-24 UDI-DI 30351688075691 Lots 6146204 (corrected on 1/22/26, removed "-LSM" suffix. 2. A3595 UDI-DI 35019517108211 Lot 6157980
- Company location
- Minneapolis, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1101-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1101-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.