KCI USA Recalls
19 recalls on record · October 3, 2012 to February 26, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 26, 2025Medical DevicesFDA
KCI USA, INC. recalls 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A
Hazard: Due to increase in complaints related to leak alarms
February 26, 2025Medical DevicesFDA
KCI USA, INC. recalls 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US P
Hazard: Due to increase in complaints related to leak alarms
December 4, 2024Medical DevicesFDA
KCI USA, INC. recalls V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an
Hazard: Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
July 15, 2020Medical DevicesFDA
KCI USA, INC. recalls ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage:
Hazard: The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
June 7, 2017Medical DevicesFDA
KCI USA, INC. recalls 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. an
Hazard: Potential sterile barrier breach
January 13, 2016Medical DevicesFDA
KCI USA, INC. recalls ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute ex
Hazard: There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.
January 14, 2015Medical DevicesFDA
KCI USA, INC. recalls CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Numbe
Hazard: KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
October 22, 2014Medical DevicesFDA
KCI USA, Inc. recalls V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring Sens
Hazard: A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
October 8, 2014Medical DevicesFDA
KCI USA, Inc. recalls CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Hazard: Blade can shift during shipping which makes the product ineffective.
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is i
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Managem
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to m
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System i
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to m
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the en
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is int
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
March 12, 2014Medical DevicesFDA
KCI USA, INC. recalls PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to man
Hazard: Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing
November 28, 2012Medical DevicesFDA
KCI USA, Inc. recalls RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of
Hazard: The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers.
October 3, 2012Medical DevicesFDA
KCI USA, Inc. recalls BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or d
Hazard: KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. The BariAir Therapy System is not designed to allow the patient to place the bed into the patient exit position. KCI has received complaints indicating that patients used the hand pendent to inadvertently place the BariAir Therapy System into a pseudo-exit position. In a small number of instances, this allow