Kendall SCD Comfort Sleeves may cause treatment delays due to software error
Kendall SCD Blended Comfort Sleeves may experience frequent E1 high-pressure errors due to software logic issues, potentially causing delays in therapy. Approximately 6517 cases distributed across the US and Japan are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is potential treatment delay from software-generated system alerts, which is a functional defect rather than a direct safety risk to patients.
Plain-English summary
The Kendall SCD Blended Comfort Sleeves (SKU 84021B) are subject to a Class II recall due to incorrect software logic in the system controller. The software defect may cause frequent E1 errors, which indicate high system pressure alerts.
These repeated error messages may cause delays in treatment or therapy administration. Affected healthcare providers and consumers may experience disruptions in care while addressing the errors.
Approximately 6517 cases have been distributed domestically within the United States (Alaska, California, Florida, Massachusetts, and Texas) and internationally to Japan. All lot numbers of this product are affected by the recall.
Consumers and healthcare facilities should contact Cardinal Health 200, LLC for guidance on resolving this issue and obtaining replacement units or corrective actions.
The recalled product
- Product
- Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- software-error
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS
Distribution
Distributed in 5 states:
- AK
- CA
- FL
- MA
- TX
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03