3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US… — Class II medical device recall Z-1175-2025
Ongoing recall by KCI USA, INC., reported 2025-02-26, distributed nationwide. Due to increase in complaints related to leak alarms
| Recall number | Z-1175-2025 |
|---|---|
| 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 | 2025-01-17 |
| Classified | 2025-02-14 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, JO, JP, KW, MX, NL, NO, NZ, OM, QA, SA, SE, SG, TR, ZA |
| Quantity | 135,268 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00849554005365, 00849554005877, 00849554005884, 00849554005891, 00849554005907, 00849554006621, 00849554006645, 00849554006744, 00849554006768, 00849554006805, 00849554007116, 00849554007130, 00849554007154, 00849554007178, 00849554007819, 00849554007826, 00849554014091, 00849554014107, 00849554014114, 00849554014121, 00849554014138, 00849554014145, 00849554014350, 50849554014096, 50849554014102 and 5 more |
| Lot numbers | C16680V006, C16715V001, C16748V002, C16749V003, C16750V004, C16751V003, C16752V004, C16753V006, C16793V005, C16794V006, C16796V009, C16797V010, C16798V011, C16801V008, C16802V006, C16874V008, C16875V006, C16878V003, C16879V004, C16880V016, C16881V017, C16882V020, C16883V001, C16928V001, C16929V003, C16930V005, C16931V002, C16932V001, C16933V002, C16934V004, C16935V001, C16998V008, C16999V006, C17000V001, C17007V005, C17024V006, C17030V008, C17031V001, C17032V006, C17129V006 and 202 more |
| Model numbers | PRE3021US, PRE3021USV005, PRE3201USV006, PRE3201USV007, PRE3201V008, PRE3201V009, PRE3201V010, PRE3201V011, PRE4000USV005, PRE4000USV008, PRE4001AUV006, PRE4001CAV006, PRE4001UKV006, PRE4001USV005, PRE4001USV006, PRE4001V006, PRE4001V008, PRE4001ZAV006, PRE4010V001, PRE4010V003, PRE4010V004, PRE4010V005, PRE4010V007, PRE4010V017, PRE4010V018 and 29 more |
Product
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM
Reason for recall
Due to increase in complaints related to leak alarms
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-1175-2025. 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.