# FDA recall Z-0507-2025

> **KCI USA, INC.** · Class II · device recall initiated 2024-11-05.

## Product

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.

## Reason for recall

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

## 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY  O.U.S.(foreign) countries to: Australia, Estonia, Italy, Norway, Spain, Austria, Finland, Japan, Oman, Sweden, Bahrain, France, Jordan, Philippines, Switzerland, Brazil, Germany, Kuwait, Poland, Thailand, Canada, Greece, Malaysia, Qatar, Tunisia, Chile, Hong Kong, Malta, Romania,  Turkey, China, India, Mexico, Saudi, Arabia, United Arab Emirates, Colombia, Indonesia, Morocco, Singapore, United Kingdom, Cyprus, Ireland, Netherlands, Slovenia, Czechia, Israel, New Zealand,  South Africa, Vietnam, and Denmark

## Key facts

- **Recall number:** Z-0507-2025
- **Recalling firm:** KCI USA, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-05
- **Report date:** 2024-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Antonio, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0507-2025

## Citation

> AI Analytics. FDA recall Z-0507-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0507-2025. Source: US FDA. Licensed CC0.

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