KCI Recalls Prevena Customizable Dressing Due to Connector Difficulty
KCI USA is recalling 20,850 units of Prevena Customizable Dressing 5-Packs because the tubing connector is difficult to attach to the canister.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect (difficulty connecting tubing) without reporting any specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
KCI USA, INC. is recalling 20,850 units of the PRE2055US Prevena Customizable Dressing 5-Pack (US-ONLY). The affected product is identified by Kit Lot # 2410918 and was distributed nationwide in the United States.
The recall was initiated because the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing. The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Consumers and healthcare facilities should stop using the affected product and contact KCI USA, INC. for further instructions or a replacement.
The recalled product
- Product
- PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and remo
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 20,850
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)
- Kit Lot # 2410918
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by KCI USA, INC. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · KCI USA, INC.
See all →- High3M Prevena Plus Negative Pressure Therapy System Recalled for Leak Alarm Malfunctions
FDA (Devices) · 2025-02-26
- High3M V.A.C. VIA Negative Pressure Wound Therapy System Recalled for Leak Alarm Malfunctions
FDA (Devices) · 2025-02-26
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighKCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off
FDA (Devices) · 2020-07-15
- HighKCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems
FDA (Devices) · 2017-06-07
Same hazard · functional defect
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07