Cardinal Health 200, LLC has recalled 6,517 cases of Kendall SCD Small Comfort Sleeves due to a software logic error. This error causes the associated Smartflow Controller to display frequent 'E1' system high pressure messages, which can interrupt or delay essential therapy. The recall affects three specific variants: Knee Length Small, Pediatric, and Blended Comfort Sleeves.
The software error triggers incorrect high-pressure alarms that shut down the device, delaying treatment meant to prevent serious conditions like deep vein thrombosis. While no injuries have been reported, frequent interruptions in therapy can pose health risks to patients requiring consistent compression.
Clinical/Hospital device correction
Recall #: Z-1917-2025. All lots are affected.
Recall #: Z-1918-2025. All lots are affected.
Recall #: Z-1919-2025. All lots are affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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