Use cautionMedical device recall · FDA · Published May 13, 2025
Cardinal Health SCD Comfort Knee Sleeves Recall: Software Error May Delay Treatment
Cardinal Health recalls SCD Comfort Knee Length Small sleeves used with Kendall SCD Smartflow. Incorrect software may cause treatment delays due to system high pressure errors.
“Cardinal Health SCD Comfort Knee Sleeves Recall: Software Error May Delay Treatment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52282-cardinal-health-scd-comfort-knee-sleeves-recall-software-error-may. Based on FDA recall #Z-1917-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1917-2025%22&limit=1).
Cardinal Health 200, LLC recalled SCD Comfort Knee Length Small sleeves and Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller due to incorrect software logic that may cause frequent E1 errors and delay treatment, according to the FDA. The agency announced the recall on May 13, 2025.
How to tell if you have it
SCD Comfort Knee Length Small, SKU 84021
Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
UDI-DI (GTIN) 10885380186516 (EA)
UDI-DI (GTIN) 50885380186514 (BX)
ALL LOTS
The hazard
Incorrect software logic may cause frequent E1 errors, indicating system high pressure. This issue may cause a delay in treatment or therapy.
Context
GovInfoNow's records show Cardinal Health 200, LLC has issued 58 other recalls since June 27, 2017. Recent brand recalls include Presource Packs containing leaking tube sets on Aug. 18, 2026, and kits with contaminated applicators on Aug. 10, 2026. Other recent recalls of similar products include Fresenius Medical Care 5008X CAREsystem Recall (Oct. 25, 2025).
How to tell if you have this one
Check for the SCD Comfort Knee Length Small sleeve with SKU 84021. These items were sold with Kendall SCD Smartflow controllers and have specific lot numbers.
Brand
Cardinal Health
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Completed
Distribution
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Recall number
Product, codes & lots
Z-1917-2025
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller; UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS
Z-1918-2025
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; UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS
Z-1919-2025
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller; UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS
Based on the official FDA remedy
What to do — step by step
Check Device Compatibility
Ensure your SCD Comfort Knee Length Small sleeve works with Kendall SCD Smartflow controllers.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1917-2025 (May 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1917-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.