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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 19 FDA device recalls.

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DateProductReasonClassFirm
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 KCI USA, INC.
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 KCI USA, INC.
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 a result of broken o... Class II KCI USA, INC.
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 stoppage of negative pre... Class II KCI USA, INC.
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 KCI USA, INC.
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 pouches of the ActiV.A.C... Class II KCI USA, INC.
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 Harvester (a component o... Class II KCI USA, INC.
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 was incorrectly manufa... Class II KCI USA, Inc.
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 KCI USA, Inc.
Jan 30, 2014 PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) P... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena In... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2001: Prevena Incision Management Customizable System Box Product Usage... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: ... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Man... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
Jan 30, 2014 PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: Th... Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is... Class II KCI USA, INC.
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 Hand Pendent. The Bari... Class II KCI USA, Inc.
Jun 27, 2012 RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and preventio... The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy Syste... Class II KCI USA, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.