FDAClass IIJune 18, 2025

Kendall SCD Blended Comfort Sleeves Knee Length Small recall: Software Issue

Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with…

Why was Kendall SCD Blended Comfort Sleeves Knee Length Small recalled?

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS

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…
Recalling firm
Cardinal Health 200, LLC
Quantity
6517 cases total
Distribution
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Recall date
June 18, 2025
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls