Manufacturer

KCI USA, Inc.

19 recalls in our database name KCI USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 19
Critical: 0
Severe: 1
Most recent: 2025-02-26

Of the 19 recalls from KCI USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

HighFDA (Devices)·Z-1175-2025·2025-02-26
3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.
Product
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1176-2025·2025-02-26
3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling approximately 2,169 units of the 3M V.A.C. VIA negative pressure wound therapy system due to increased complaints about leak alarm malfunctions affecting certain units.
Product
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0507-2025·2024-12-04
V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.
Product
V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2542-2020·2020-07-15
KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off
KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.
Product
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2017·2017-06-07
KCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems
KCI USA is recalling 5,385 cases of 1000 ml canisters for InfoV.A.C. and V.A.C.ULTA systems due to a potential sterile barrier breach.
Product
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0600-2016·2016-01-13
KCI ActiV.A.C. Canisters Recalled for Potential Pinhole Leaks
KCI USA is recalling ActiV.A.C. 300ml Canisters distributed in Japan and Australia due to potential pinhole leaks in the pouches.
Product
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 connecte
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0933-2015·2015-01-14
KCI CelluTome Epidermal Harvesting System Harvester Blades May Drift During Shipping
KCI USA is recalling CelluTome Epidermal Harvesting System Harvesters because blades may drift and protrude from the top plate during shipping.
Product
CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0070-2015·2014-10-22
KCI Recalls V.A.C. GranuFoam Silver Dressing Due to Expiry Date Error
KCI USA, Inc. is recalling V.A.C. GranuFoam Silver Dressing because some sterile pouches display an incorrect expiry date.
Product
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2717-2014·2014-10-08
KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift
KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.
Product
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1137-2014·2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues
KCI USA is recalling 20,850 Prevena Dressing kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the ap
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1138-2014·2014-03-12
KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty
KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.
Product
PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1142-2014·2014-03-12
KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty
KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.
Product
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and remo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1136-2014·2014-03-12
KCI USA Recalls Prevena Peel and Place System Kits
KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect to the canister.
Product
PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1139-2014·2014-03-12
KCI Recalls Prevena Incision Management System Kits Due to Connector Issues
KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.
Product
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and r
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1140-2014·2014-03-12
KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue
KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.
Product
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1135-2014·2014-03-12
KCI Prevena Peel and Place System Kit Recalled for Connector Issues
KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect to the female canister connector.
Product
PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1141-2014·2014-03-12
KCI Recalls Prevena Incision Management System Due to Connector Difficulty
KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.
Product
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed envir
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0409-2013·2012-11-28
KCI RotoRest Delta Therapy System Head Pack Recalled for Skin Injury
KCI USA is voluntarily recalling 282 RotoRest Delta Therapy System head packs due to reports of skin breakdown and pressure ulcers.
Product
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2466-2012·2012-10-03
KCI Recalls BariAir Therapy System Hand Pendent Due to Positioning Risk
KCI USA, Inc. is recalling 575 BariAir Therapy System Hand Pendants because patients may inadvertently place the bed into a pseudo-exit position, posing a safety risk.
Product
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient
Category
Medical Device
Distribution
Distributed nationwide