CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Pulsator Arterial Blood Sampling Kit recalled by ICU Medical

ICU Medical is recalling Pulsator Arterial Blood Sampling Kit, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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

Quantity recalled64290 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1100-2026
FDA event ID: 98168
Recalling firm: ICU Medical, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2025
FDA classified: 15 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

19 Dec 2025	Recall initiated by company
15 Jan 2026	Classified by FDA	+27 days
21 Jan 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

Where it was distributed

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

Nationwide California Florida Illinois Indiana Massachusetts Michigan Minnesota Missouri Nebraska New Jersey New York Ohio Oklahoma Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of CA, FL, IL, IN, MA, MI, MN, MO, NE, NJ, NY, OH, OK, TX, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98168

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026	CLASS II	Portex Spinal Tray recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide

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