KCI USA, INC. is recalling approximately 137,437 units of the 3M Prevena Plus 125 Therapy Unit, System Kits, and 3M V.A.C. VIA Negative Pressure Wound Therapy Systems. These medical devices, used to manage surgical incisions and various wound types, are being recalled due to an increase in reports regarding issues with the devices' leak alarms. The recall includes 135,268 Prevena Plus units and 2,169 V.A.C. VIA units distributed worldwide, including throughout the United States.
If the leak alarm system on these therapy units fails or functions incorrectly, it can lead to ineffective wound therapy or a delay in proper healing. While no specific injuries have been detailed, a malfunction in the negative pressure system used for wound management can compromise the integrity of the treatment site.
Recall Number Z-1175-2025.
Recall Number Z-1176-2025.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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