PlainRecalls

KCI USA, INC.

13 recalls on record · Latest: Feb 26, 2025

KCI USA, INC. Recall Insight

KCI USA, INC. appears on 13 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.015% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 26, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 13 entries, severity tagging shows 0 critical, 13 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 13 of 13 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (13). The date window on this page runs from Mar 12, 2014 to Feb 26, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Feb 26, 2025

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 …

FDA Devices Moderate Feb 26, 2025

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 an…

FDA Devices Moderate Dec 4, 2024

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…

FDA Devices Moderate Jun 7, 2017

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 Pressur…

FDA Devices Moderate Jan 13, 2016

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…

FDA Devices Moderate Jan 14, 2015

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 Cellu…

FDA Devices Moderate Oct 22, 2014

V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M827…

FDA Devices Moderate Oct 8, 2014

CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

FDA Devices Moderate Mar 12, 2014

PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environme…

FDA Devices Moderate Mar 12, 2014

PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisio…

FDA Devices Moderate Mar 12, 2014

PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environ…

FDA Devices Moderate Mar 12, 2014

PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the envi…

FDA Devices Moderate Mar 12, 2014

PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surg…

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds