Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump"… — Class II medical device recall Z-0207-2026
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-0207-2026 |
|---|---|
| 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 | 10192253012453, 10192253012972, 10192253012996, 10884521067196, 10884521067202, 10884521067219, 10884521067226, 50192253008171, 50192253008195, 50192253008201, 50192253008218 |
Product
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm) 5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm) 5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm) 5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm) 5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm) 8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm) 8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm) 8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)
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-0207-2026. 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.