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KCI USA, INC.

28 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and recall (Z-1175-2025)KCI USA, INC.2025-02-14
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 D recall (Z-1176-2025)KCI USA, INC.2025-02-14
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure recall (Z-0507-2025)KCI USA, INC.2024-11-22
ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of recall (Z-0600-2016)KCI USA, INC.2016-01-06
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured f recall (Z-0933-2015)KCI USA, INC.2015-01-07
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help re recall (Z-0070-2015)KCI USA, Inc.2014-10-15
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 recall (Z-2717-2014)KCI USA, Inc.2014-09-29
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management recall (Z-1135-2014)KCI USA, INC.2014-03-05
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision recall (Z-1136-2014)KCI USA, INC.2014-03-05
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is recall (Z-1137-2014)KCI USA, INC.2014-03-05
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Manageme recall (Z-1138-2014)KCI USA, INC.2014-03-05
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena In recall (Z-1139-2014)KCI USA, INC.2014-03-05
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Manageme recall (Z-1140-2014)KCI USA, INC.2014-03-05
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: Th recall (Z-1141-2014)KCI USA, INC.2014-03-05
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incis recall (Z-1142-2014)KCI USA, INC.2014-03-05
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary c recall (Z-0409-2013)KCI USA, Inc.2012-11-20
BariAir Therapy System The BariAir Therapy System is a risk management treatment system de recall (Z-2466-2012)KCI USA, Inc.2012-09-27
Zuma Mobility System Models: Zuma Mobility Assist 412045-01 and Zuma Mobility Trainer 4120 recall (Z-1431-2012)KCI USA, Inc.2012-04-16
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface dur recall (Z-2182-2011)KCI USA, Inc.2011-05-10
RotoProne Therapy System, Model 209500, Device List Number E232632 Product is designed to recall (Z-0611-2011)KCI USA, Inc.2010-12-13
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0662-2010)KCI USA, Inc.2010-01-25
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0663-2010)KCI USA, Inc.2010-01-25
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0664-2010)KCI USA, Inc.2010-01-25
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0665-2010)KCI USA, Inc.2010-01-25
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0666-2010)KCI USA, Inc.2010-01-25
AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. recall (Z-0667-2010)KCI USA, Inc.2010-01-25
500 mL InfoV.A.C. Canisters (with Gel); Part #M8275063/5 (5 canister pack) and Part #M8275 recall (Z-2439-2008)KCI USA, Inc.2008-09-20
500 mL InfoV.A.C. Canister (without Gel); Part #M8275071/5 (5 canister pack) and Part #M82 recall (Z-2440-2008)KCI USA, Inc.2008-09-20

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