Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1100-2026 — Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

U.S. FDA — Device Enforcement · United States · 2025-12-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1100-2026
Date of alert
2025-12-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30351688073062
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.