Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit"… — Class II medical device recall Z-0206-2026
Ongoing recall by Cardinal Health 200, LLC, reported 2025-10-29, distributed nationwide. Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Fir
| Recall number | Z-0206-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2025-09-18 |
| Classified | 2025-10-17 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CA, CH, CL, CO, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IT, JO, KW, LU, MX, NL, NO, NZ, PA, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, TH, TW, VN, ZA |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10192253012774, 10192253012798, 10192253012811, 10192253012835, 10192253012859, 10884521779419, 10884521779426, 10884521779433, 10884521779440, 10884521779457, 10884521779464, 10884521779471 |
Product
Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN 8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN 8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN 8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN 8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN 8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN 8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN 8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
Reason for recall
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
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-0206-2026. 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.