# FDA recall Z-1668-2025

> **Smiths Medical ASD, Inc.** · Class I · device recall initiated 2025-04-10.

## Product

CADD-Solis VIP Ambulatory Infusion Pump;   Model/Number:    21-2120-0100-02  21-2120-0100-03  21-2120-0100-06  21-2120-0100-232  21-2120-0100-233  21-2120-0100-50  21-2120-0100-51  21-2120-0100-95  21-2120-0102-02  21-2120-0102-03  21-2120-0102-06  21-2120-0102-07  21-2120-0102-08  21-2120-0102-12  21-2120-0102-13  21-2120-0102-14  21-2120-0102-15  21-2120-0102-17  21-2120-0102-237  21-2120-0102-238  21-2120-0102-247  21-2120-0102-249  21-2120-0102-51  21-2120-0102-78  21-2120-0102-92  21-2120-0102-97  21-2120-0102-98  21-2120-0103-01  21-2120-0103-02  21-2120-0103-03  21-2120-0103-06  21-2120-0103-07  21-2120-0103-08  21-2120-0103-12  21-2120-0103-14  21-2120-0103-15  21-2120-0103-17  21-2120-0103-249  21-2120-0103-51  21-2120-0103-78  21-2120-0104-01  21-2120-0104-231  21-2120-0105-00  21-2120-0105-01  21-2120-0105-02L  21-2120-0105-03L  21-2120-0105-06L  21-2120-0105-07L  21-2120-0105-08  21-2120-0105-08L  21-2120-0105-12L  21-2120-0105-13L  21-2120-0105-14L  21-2120-0105-15L  21-21

## Reason for recall

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

## Distribution

Worldwide - US nationwide distribution.

## Key facts

- **Recall number:** Z-1668-2025
- **Recalling firm:** Smiths Medical ASD, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-10
- **Report date:** 2025-05-14

- **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-1668-2025

## Citation

> AI Analytics. FDA recall Z-1668-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1668-2025. Source: US FDA. Licensed CC0.

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