FDA Device recall Z-1917-2025
SCD Comfort Knee Length Small, SKU 84021
- FDA Device
- Class II
- completed
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class II recall of SCD Comfort Knee Length Small, SKU 84021 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-1917-2025 |
| 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
SCD Comfort Knee Length Small, SKU 84021; 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) 10885380186516 (EA) 50885380186514 (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-1917-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.