FDA Device recall Z-1918-2025
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves…
- FDA Device
- Class II
- completed
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves… by Cardinal Health 200, citing incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1918-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-05-13 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | AK, CA, FL, MA, TX |
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
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Identifiers
| code_info | UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1918-2025%22
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