Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for Recalled by KCI USA, INC. Due to There is potential for small holes, the size...
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. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.
Quantity: 12,728 units
Why Was This Recalled?
There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
Where Was This Sold?
Japan and Australia
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