Kendall recallZ-1917-2025 · Cardinal Health 200, LLC · initiated May 13, 2025
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
FDA root cause category: Software change control
What the company is doing
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.
Recall details
- Recall number
- Z-1917-2025
- Status
- Completed
- Initiated by the company
- May 13, 2025
- Posted by the FDA
- Jun 6, 2025
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 6517 cases total
- Product code
- JOW
- FDA submissions
- K230028
- Distribution
- Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
Product description
SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
Code information (models, lots, serial numbers)
UDI-DI (GTIN) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Kendall 84021Cardinal Health 200, LLC · SLEEVE, LIMB, COMPRESSIBLE2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96849).
- Z-1918-2025 · CompletedKendall 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 Smartflo…
- Z-1919-2025 · CompletedKendall 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 C…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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