# FDA recall Z-1681-2025

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

## Product

CADD-Solis Infusion Pump Models:   1) PUMP KIT, CADD-SOLIS, MDL 2110,  V4.2,  CE ENGLISH     1/EA, Model Number: 21-2111-0402-51;    2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2,  YELLOW, CE ENGLISH     1/EA, Model Number: 21-2112-0402-51;    3) PUMP KIT, CADD-SOLIS, YELLOW,  MODEL 2110     1/EA, Model Number: 21-2112-0100-51;    4) PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH     1/EA, Model Number: 21-2112-0300-01;    5) PUMP KIT, CADD-SOLIS HPCA PIB,  MODEL 2110, NA ENGLISH     1/EA, Model Number: 21-2111-0300-01;     6) PUMP KIT, CADD-SOLIS, MDL 2110,  V4.1,  CE ENGLISH     1/EA, Model Number: 21-2111-0401-51;    7) PUMP KIT, CADD-SOLIS, MODEL 2110, CE ENGLISH     1/EA, Model Number: 21-2111-0100-51;   8) PUMP KIT, CADD-SOLIS, MDL 2110, V4.1,  YELLOW, CE ENGLISH     1/EA, Model Number: 21-2112-0401-51;   9) PUMP KIT, CADD-SOLIS, MDL 2100, CE ENGLISH     1/EA, Model Number: 21-2101-51;   10) PUMP KIT, CADD-SOLIS, MDL 2110, V4.0,  CE ENGLISH     1/EA, Model Number:

## Reason for recall

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1681-2025
- **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-1681-2025

## Citation

> AI Analytics. FDA recall Z-1681-2025. Retrieved 2026-08-22 from https://api.ai-analytics.org/recall/Z-1681-2025. Source: US FDA. Licensed CC0.

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