Cardinal Health 200, LLC: Device Recall
Recall #Z-1917-2025 · 05/13/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1917-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Cardinal Health 200, LLC
- Status
- Ongoing
- Date Initiated
- 05/13/2025
- Location
- Waukegan, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6517 cases total
Reason for Recall
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Product Description
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Distribution Pattern
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Other Recalls by Cardinal Health 200, LLC
- Class II: Risk 12/26/2025
- Class II: Risk 11/12/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.