ACTIV — Class II medical device recall Z-2542-2020
Terminated recall by KCI USA, INC., reported 2020-07-15, distributed nationwide. The device may power off without notification to the user resulting in a stoppage of negative pressure wound t
| Recall number | Z-2542-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, INC., San Antonio, TX, United States |
| Recall initiated | 2020-06-08 |
| Classified | 2020-07-09 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2023-02-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CN, DE, FR, GB, HK, ID, IN, JP, KR, LK, MY, NZ, PH, TH, TW, VN |
| Quantity | 5,823 units |
| UPC / GTIN / UDI-DI | 00878237008188 |
| Model numbers | 340000 |
Product
ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
Reason for recall
The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2542-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.