V — Class II medical device recall Z-0507-2025
Ongoing recall by KCI USA, INC., reported 2024-12-04, distributed nationwide. Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sens
| Recall number | Z-0507-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | KCI USA, INC., San Antonio, TX, United States |
| Recall initiated | 2024-11-05 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IT, JO, JP, KW, MA, MT, MX, MY, NL, NO, NZ, OM, PH, PL, QA, RO, SE, SG, SI, TH, TN, TR, VN, ZA |
| Quantity | 83,721 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00849554000636, 00849554001084 |
| Serial numbers | 7114, 741, AC12052, FVS13805, GAAC00001, GAAC00002, GAAC00003, GAAC00004, GAAC00005, GAAC00006, GAAC00007, GAAC00008, GAAC00009, GAAC00010, GAAC00011, GAAC00012, GAAC00013, GAAC00014, GAAC00015, GAAC00016, GAAC00017, GAAC00018, GAAC00019, GAAC00020, GAAC00021 and 475 more |
| Model numbers | CAPULTDEV01, CAPULTDEV01/BR.S, CAPULTDEV01/CZ.S, CAPULTDEV01/HR.S, CAPULTDEV01/HU.S, CAPULTDEV01/ID.S, CAPULTDEV01/PL.S, CAPULTDEV01/RO.S, CAPULTDEV01/SI.S, CAPULTDEV01/SK.S, CAPULTDEV01/US.S, HCULTDEV01/FR.S, ULTDEV01, ULTDEV01/AU.S, ULTDEV01/BE.S, ULTDEV01/CA.S, ULTDEV01/CH.S, ULTDEV01/CN.S, ULTDEV01/DE.S, ULTDEV01/DK.S, ULTDEV01/ES.S, ULTDEV01/EU.S, ULTDEV01/FI.S, ULTDEV01/FR.S, ULTDEV01/GR.S and 10 more |
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.
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-0507-2025. 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.