Cardinal Health 200, LLC Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Brand
Cardinal Health 200, LLC
Lot Codes / Batch Numbers
UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS
Products Sold
UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS
Cardinal Health 200, LLC is recalling Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 8 due to Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Recommended Action
Per FDA guidance
On May 13, 2025, the firm began to notify customers via Urgent Medical Device Product Correction letters. Customers were informed of the issue, which exclusively impacts use of the Comfort Small Knee Sleeve. Other sleeve sizes are unaffected and operate as intended with the SmartFlow Controller. The product remains operational if the Comfort Small Knee Sleeve and SmartFlow Controller configuration is not utilized during therapy. A software update on the SmartFlow Controller is necessary before using the SmartFlow controller with the Comfort Small Knee sleeve configuration. Customers should discontinue use of the Comfort Small Knee Sleeve with the SmartFlow Controller and utilize a suitable alternative such as SM thigh or foot cuff. Customer service representatives will coordinate with customers to facilitate a software update which will allow the controllers to be utilized with the small knee sleeves without causing the error.
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
AK, CA, FL, MA, TX
Page updated: Jan 10, 2026
Important Notice
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