# FDA recall Z-1918-2025

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2025-05-13.

## Product

Kendall SCD Comfort Sleeves  Knee Length Small, Pediatric -  For use with Kendall SCD  SmartFlow, SKU 84021P    Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

## Reason for recall

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

## Distribution

Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.

## Key facts

- **Recall number:** Z-1918-2025
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2025-05-13
- **Report date:** 2025-06-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1918-2025

## Citation

> AI Analytics. FDA recall Z-1918-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1918-2025. Source: US FDA. Licensed CC0.

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