KCI USA recalls

KCI USA has 18 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 26 Feb 2025. 2 are still ongoing.

Total recalls18since 2012
Last 12 months0reported
Class I00% of total
Ongoing2latest 26 Feb 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 18 100%Class III 0 0%

Why kci usa is recalled

By year

Ongoing kci usa recalls

2 active

All kci usa recalls, newest first

18 total
ReportedClassRecallCompanyReasonWhere
DeviceCLASS II3M Prevena Plus 125 Therapy Unit and System Kits recalled by Kci UsaKCI USAPackaging DefectsNationwide
DeviceCLASS II3M V.A.C. VIA Negative Pressure Wound Therapy System recalled by Kci UsaKCI USAPackaging DefectsNationwide
DeviceCLASS IIActiv.A.C Therapy System recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IICanister (with Gel) for InfoV.A.C recalled by Kci UsaKCI USASterilityNationwide
DeviceCLASS IIActiV.A.C. Canister (with Gel) recalled by Kci UsaKCI USASterilityTX
DeviceCLASS IICelluTome Epidermal Harvesting System Harvester Sterile EO recalledKCI USAOtherNationwide
DeviceCLASS IIV.A.C. GranuFoam Silver Large Dressing is barrier recalled by Kci UsaKCI USASterilityTX
DeviceCLASS IICelluTome Epidermal Harvesting System recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE1055US: Prevena Dressing (Us-only) recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE2001US: Prevena Incision Management Customizable System recalledKCI USAOtherNationwide
DeviceCLASS IIPRE1001: Prevena Peel and Place System Kit recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE2055: Prevena Customizable Dressing recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE2001: Prevena Incision Management Customizable System recalledKCI USAOtherNationwide
DeviceCLASS IIPRE2055US: Prevena Customizable Dressing (Us-only) recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE1055: Prevena Dressing recalled by Kci UsaKCI USAOtherNationwide
DeviceCLASS IIPRE1001US: Prevena Peel and Place System Kit (Us-only) recalledKCI USAOtherNationwide
DeviceCLASS IIRotoRest Delta Kinetic Therapy System recalled by Kci UsaKCI USADevice MalfunctionNationwide
DeviceCLASS IIBariAir Therapy System The BariAir Therapy System is a risk recalledKCI USAOtherNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.