The Recall Desk
HighFDA (Devices)·Z-1918-2025·Announced 2025-06-18

Kendall SCD Comfort Sleeves Pediatric Knee Length Software Error Recall

Kendall SCD Comfort Sleeves Knee Length Small Pediatric models may experience frequent E1 errors due to incorrect software logic, potentially delaying treatment or therapy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device where the hazard—software error causing treatment delay—poses a risk of harm. The source text explicitly states no illnesses or injuries have been reported, making this a theoretical risk scenario that per the rubric warrants a score of at most 3.

Plain-English summary

Cardinal Health 200, LLC is recalling Kendall SCD Comfort Sleeves Knee Length Small, Pediatric (SKU 84021P) for use with the Kendall SCD SmartFlow controller. The product is affected by incorrect software logic that may cause frequent E1 errors indicating high system pressure.

The issue may cause delays in treatment or therapy. The recall affects approximately 6,517 cases distributed domestically within the United States to Alaska, California, Florida, Massachusetts, and Texas, as well as international distribution to Japan. All lots of the product are affected, identified by UDI-DI (GTIN) 10885380197925 (EA) and 50885380197923 (BX).

Patients and healthcare providers using these sleeves should contact Cardinal Health 200, LLC for instructions on how to address the software error or obtain replacement units. Users experiencing E1 errors should not delay seeking appropriate care and should consult their healthcare provider.

The recalled product

Product
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
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Sequential Compression Device / Therapy Equipment
Hazard
Affected units
6,517

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI (GTIN) 10885380197925 (EA) 50885380197923 (BX) ALL LOTS

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · software error

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