Food, drugs, devices › Cardinal Health 200, LLC
Device recall: SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con
FDA enforcement event 96849 is a device recall by Cardinal Health 200, LLC of Waukegan, IL, initiated 13 May 2025 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Cardinal Health 200, LLC has 59 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Cardinal Health 200, LLC, Waukegan, IL.
Reason for recall
"Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy."
Distribution
"Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1917-2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller | 6517 cases total | Class II | Completed | 18 Jun 2025 |
| 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 | 6517 cases total | Class II | Completed | 18 Jun 2025 |
| 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 | 6517 cases total | Class II | Completed | 18 Jun 2025 |
Context
Other enforcement events for Cardinal Health 200, LLC
All 59 events for Cardinal Health 200, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan."
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.