SCD Comfort Knee Length Small Sequential Compression Device Recalled for Software Error
Cardinal Health recalls SCD Comfort Knee Length Small compression sleeves due to software logic errors causing frequent high-pressure alerts. The malfunction may delay patient treatment or therapy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a functional defect (software error) in a therapeutic medical device. Although no injuries or illnesses have been reported, the potential for treatment delays in patient-critical equipment qualifies this as a risk-of-harm situation, warranting High severity.
Plain-English summary
Cardinal Health 200, LLC is recalling the SCD Comfort Knee Length Small (SKU 84021) Sequential Compression Device sleeves when used with the Kendall SCD Smartflow Controller due to incorrect software logic in the device controller.
The software error causes frequent E1 errors, which signal high system pressure conditions. These false alerts may delay patient treatment or therapy delivery.
Approximately 6,517 cases have been distributed within the United States (Alaska, California, Florida, Massachusetts, and Texas) and internationally to Japan. All product lots are affected.
Patients and healthcare facilities currently using affected devices should be aware of this potential operational issue.
The recalled product
- Product
- SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- software-error
- high-pressure-alert
- therapy-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) 50885380186514 (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