Reported Jan 21, 2026 · Ongoing
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 303516880730624044EG-1 UDI-DI 30351688073062 Lots 6141992 6156228 2 303516880061764080P-2 UDI-DI 30351688006176 Lots 6141999 6142000 6147906 3 303516880295404084P-1 UDI-DI 30351688029540 Lots 6147907 (corrected 1/22/26, removed "-LSM" suffix) 4 303516880391504080PE UDI-DI 30351688039150 Lot 6131839 5 303516880811734080PG UDI-DI 30351688081173 Lots 6131838 6142001 6142002 - Amount recalled
- 64290 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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