SCD Comfort Knee Length sleeves recalled for software logic errors
Cardinal Health is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) due to incorrect software logic that may cause frequent E1 errors and delay patient treatment.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 incorrect software logic poses a risk of treatment delay—a potential harm scenario. The source text does not report any actual injuries or illnesses, but the risk of delayed therapy in a compression device indicates a High severity per the rubric's criterion for risk-of-harm products without reported adverse events.
Plain-English summary
Cardinal Health 200, LLC is recalling SCD Comfort Knee Length Small sleeves (SKU 84021) when used with the Kendall SCD Smartflow Controller. The recall affects approximately 6,517 cases.
Incorrect software logic in the device may cause frequent E1 errors, which indicate system high pressure conditions. This issue may cause delay in treatment or therapy for patients using the device.
The affected product was distributed domestically across Alaska, California, Florida, Massachusetts, and Texas, as well as internationally to Japan. All lots are included in this recall (UDI-DI: 10885380186516 for individual units; 50885380186514 for boxes).
Patients and healthcare providers currently using this device should contact Cardinal Health 200, LLC or consult their healthcare provider for instructions regarding continued use and potential replacement options.
The recalled product
- Product
- SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller
- Manufacturer
- Cardinal Health 200, LLC
- 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) 10885380186516 (EA) 50885380186514 (BX) ALL LOTS
Distribution
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.
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