# FDA recall Z-2525-2025

> **ICU Medical Inc.** · Class II · device recall initiated 2025-08-06.

## Product

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

## Reason for recall

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing.  This could result in medication leakage along the bag perimeter.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2525-2025
- **Recalling firm:** ICU Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-06
- **Report date:** 2025-09-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2525-2025

## Citation

> AI Analytics. FDA recall Z-2525-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2525-2025. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*