Device recall: V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an…

Class II FDA enforcement event 95580. Recall start date: 5 Nov 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

KCI USA, INC. started this device recall on 5 Nov 2024. The firm address in the FDA record is in San Antonio, TX. FDA put the recall in Class II. FDA event 95580 has 1 product record. The first FDA enforcement report date is 4 Dec 2024. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,…

Recalling firm

KCI USA, INC., San Antonio, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 95580: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0507-2025	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.	83,721 devices	Class II	Ongoing	4 Dec 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class II: 87%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 11

Other events of the firm

Other FDA enforcement events of KCI USA, INC.
Initiated	Product (first record)	Type	Class	Records
17 Jan 2025	3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3	Device	Class II	2
8 Jun 2020	ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: i	Device	Class II	1
28 Apr 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	Device	Class II	1
25 Nov 2015	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	Device	Class II	1
19 Nov 2014	CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number	Device	Class II	1
18 Sep 2014	V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring Sens	Device	Class II	1
19 May 2014	CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50	Device	Class II	1
30 Jan 2014	PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage t	Device	Class II	8
17 Sep 2012	BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or diff	Device	Class II	1
27 Jun 2012	RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of im	Device	Class II	1

KCI USA, INC.: all 11 events

Official channels

FDA enforcement report Z-0507-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 95580. https://recallregister.com/fda/ii/95580/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA,…
What quantity of product is in FDA event 95580?: The FDA record gives this quantity: 83,721 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 87% of the 970 device events that started in 2024 are in Class II.