Medical DeviceFeb 26, 2025
KCI USA 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. recall — FDA Z-1176-2025
Due to increase in complaints related to leak alarms
Class IIFDA: OngoingKCI USA, Inc.
Recall history in this database
Classification mix: Class II: 3.
Medical DeviceFeb 26, 2025
KCI USA 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo recall — FDA Z-1175-2025
Due to increase in complaints related to leak alarms
Class IIFDA: OngoingKCI USA, Inc.
Medical DeviceDec 4, 2024
KCI USA V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative recall — FDA Z-0507-2025
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Class IIFDA: OngoingKCI USA, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies KCI USA, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.