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

ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 — recall Z-0357-2026

U.S. FDA — Device Enforcement · United States · 2025-09-08 · Class II

As described by U.S. FDA — Device Enforcement: ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0357-2026
Date of alert
2025-09-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.
Reported risk: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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