SCD Comfort Knee Length Small — Class II medical device recall Z-1917-2025
Completed recall by Cardinal Health 200, LLC, reported 2025-06-18, distributed in AK, CA, FL, MA, TX. Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatme
| Recall number | Z-1917-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2025-05-13 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | AK, CA, FL, MA, TX |
| Countries outside the US | JP |
| Quantity | 6,517 cases |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10885380186516, 50885380186514 |
Product
SCD Comfort Knee Length Small, SKU 84021; 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1917-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.