ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit
- Recalling company
- ICU Medical Inc.
- Product
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- 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. 4044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2. 4080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3. 4084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4. 4080PE UDI-DI 30351688039150 Lot 6131839 5. 4080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002
- Company location
- Minneapolis, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1100-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1100-2026 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.