# FDA recall Z-3212-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2026-08-20.

## Product

CADD Yellow Medication Cassette Reservoir with NRFit connector    US Product Codes: 21-7600-24, 21-7609-24    OUS Product Codes:  21-7609-24  21-7600-24  21-7600-24  21-7600-24  21-7609-24  21-7609-24  21-7600-24  21-7600-24  21-7609-24  21-7609-24  21-7600-24  21-7600-24  21-7609-24  21-7600-24  21-7600-24  21-7609-24  21-7609-24JP  21-7600-24JP  21-7609-24  21-7609-24  21-7600-24  21-7600-24  21-7609-24  21-7600-24  21-7600-24  21-7600-24  21-7609-24

## Reason for recall

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS,  TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.

## Key facts

- **Recall number:** Z-3212-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-08-20
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3212-2026

## Citation

> MORVS. FDA recall Z-3212-2026. Retrieved 2026-11-01 from https://api.morvs.ai/recall/Z-3212-2026. Source: US FDA. Licensed CC0.

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