3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions
KCI USA is recalling 3M Prevena Plus wound therapy systems due to complaints about malfunctioning leak alarms. The recall affects 135,268 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with complaints of leak alarm malfunction on a wound therapy device. No hospitalizations or injuries are reported. This qualifies as High severity based on the risk-of-harm criterion for device malfunctions without reported injuries.
Plain-English summary
3M Prevena Plus 125 Therapy Unit and System Kits are being recalled by KCI USA, Inc., the manufacturer. The recall includes multiple product models and variants, including Prevena Plus Duo Peel and Place System Kits, Prevena Plus Peel and Place System Kits, the Prevena Plus 125 Therapy Unit, and Prevena Restor System Kits. A total of 135,268 units are affected by this recall.
The recall was initiated due to an increase in complaints related to malfunction of the leak alarm function on the therapy systems. The specific nature and impact of the leak alarm malfunction are not detailed in the FDA recall notice.
The affected products have been distributed worldwide, including throughout the United States (all 50 states plus Puerto Rico and Washington DC) and internationally to over 30 countries including Canada, Australia, the United Kingdom, Japan, China, and numerous European nations. Specific lot numbers for each product variant are listed in the FDA recall notice.
Patients and healthcare providers currently using these devices should check the FDA recall notice for their specific device model and lot number. Healthcare facilities should consult with 3M/KCI USA for instructions regarding use or replacement of affected units. Adverse events related to these devices can be reported to the FDA MedWatch program.
The recalled product
- Product
- 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 and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, U
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Therapy
- Hazard
- alarm-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27