Recall Z-1100-2026— ICU Medical Inc.

Name: FDA recall Z-1100-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Class II · Ongoing

Class II FDA medical device recall by ICU Medical Inc., initiated 2025-12-19. It names one FDA 510(k) clearance: K952516. 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..

Recalling firm: ICU Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-19
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K952516 — PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc.·cleared 1995-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.