FDA Medical devices recall ·
Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with… recall
- Recall number
- Z-1919-2025
- Date
- (initiated May 13, 2025)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Completed
- Units affected
- 6517 cases total
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI (GTIN) 10885380186516 (EA) 50885380194687 (BX) ALL LOTS
Distribution
Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.
States: Alaska California Florida Massachusetts Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1919-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.