Recall archive / FDA device enforcement
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ... — FDA record Z-1917-2025
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 13, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 6517 cases total
- Agency-reported status
- Completed
- Source record identifier
- Z-1917-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jun 18, 2025
- Recall initiation date
- May 13, 2025
- Center classification date
- Jun 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.