# FDA recall Z-0154-2026

> **ICU Medical, Inc.** · Class I · device recall initiated 2025-10-02.

## Product

IV Administration sets.    23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359;  23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213;  70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732;  80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733;  53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014

## Reason for recall

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

## Distribution

Worldwide distribution: US (nationwide) to states of: TX, SC and OUS (foreign) to countries of: Canada, Australia, and New Zealand.

## Key facts

- **Recall number:** Z-0154-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-02
- **Report date:** 2025-10-29

- **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-0154-2026

## Citation

> AI Analytics. FDA recall Z-0154-2026. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0154-2026. Source: US FDA. Licensed CC0.

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