Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" Recalled by KCI USA, INC. Due to Due to potential system error alarm and the...

Date: November 5, 2024
Company: KCI USA, INC.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact KCI USA, INC. directly.

Affected Products

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.

Quantity: 83,721 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About KCI USA, INC.

KCI USA, INC. has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report