Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ACTIV.A.C Therapy System Recalled by KCI USA, INC. Due to The device may power off without notification to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact KCI USA, INC. directly.
Affected Products
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
Quantity: 5,823 units
Why Was This Recalled?
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About KCI USA, INC.
KCI USA, INC. has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report