Cardinal Health 200, LLC: Medical Device Recall in 2025 - (Recall #: Z-1918-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 13, 2025

Date Posted: June 18, 2025

Recall Number: Z-1918-2025

Event ID: 96849

Reason for Recall:

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

Status: Completed

Product Quantity: 6517 cases total

Code Information:

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

Distribution Pattern:

Domestic US distribution to AK, CA, FL, MA, TX. International distribution to Japan.

Voluntary or Mandated:

Voluntary: Firm initiated