SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Recall Insight

This FDA Devices action (record #Z-1917-2025) was formally reported on June 18, 2025, with the manufacturer initiating the action on May 13, 2025. It is classified under Moderate severity (Class II), with a current status of Completed. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records indicate 6517 cases total units are affected.

The documented reason for this recall is: Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. Distribution data in the federal record shows the product reached: Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.