Kci Usa, Inc.

Complete recall history across all FDA and CPSC categories — 19 total recalls

Kci Usa, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Kci Usa, Inc.

Date Product Reason Class
Jan 17, 2025 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plu... Due to increase in complaints related to leak alarms Class II
Jan 17, 2025 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US -... Due to increase in complaints related to leak alarms Class II
Nov 5, 2024 V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta N... Due to potential system error alarm and the inability to initiate therapy as ... Class II
Jun 8, 2020 ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERIC... The device may power off without notification to the user resulting in a stop... Class II
Apr 28, 2017 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Pa... Potential sterile barrier breach Class II
Nov 25, 2015 ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the ap... There is potential for small holes, the size of a pin, to develop in the pouc... Class II
Nov 19, 2014 CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only M... KCI has received reports that, in a small number of cases, the CelluTome Harv... Class II
Sep 18, 2014 V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration an... A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 wa... Class II
May 19, 2014 CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 Blade can shift during shipping which makes the product ineffective. Class II
Jan 30, 2014 PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE2001: Prevena Incision Management Customizable System Box Product Usage... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Jan 30, 2014 PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... Prevena Incisional Management System Kit/Dressing Connector - the male connec... Class II
Sep 17, 2012 BariAir Therapy System The BariAir Therapy System is a risk management tre... KCI has issued a medical device correction for the BariAir Therapy System Han... Class II
Jun 27, 2012 RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and preventio... The firm is initiating a voluntary medical device correction for the RotoRest... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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