# FDA recall Z-0357-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-09-08.

## Product

ICU Medical  ChemoLock Port w/Spiros, Red Cap  REF: CL-35

## Reason for recall

Port weld of drug transfer device  may separate or break during use and potentially result in a leak.

## 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.

## Key facts

- **Recall number:** Z-0357-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-08
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Clemente, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0357-2026

## Citation

> AI Analytics. FDA recall Z-0357-2026. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0357-2026. Source: US FDA. Licensed CC0.

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