DeRoyal REF 71-C5100NS Tubing — Class II medical device recall Z-1291-2025
Ongoing recall by DeRoyal Industries Inc, reported 2025-03-12, distributed in IL, MN, NC, PA, VA. Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port con
| Recall number | Z-1291-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2025-01-31 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | IL, MN, NC, PA, VA |
| Quantity | 714 cases |
| UPC / GTIN / UDI-DI | 00749756578738, 00749756578851, 00749756578967 |
| Lot numbers | 71-C6100NS, 71-C7100NS, CNWKD04-04, CNWKD04-05, CNWKD04-06, CNWKD04-07, CNWKD04-10, CNWKD09-08 |
| Model numbers | 71-C5100NS, 71-C6100NS, 71-C7100NS |
Product
DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
Reason for recall
Due to the inner diameter of the suction tubing connector being smaller than the suction canister lid port connection. This size difference, combined with the durometer of the plastic material, makes the assembly to a suction canister lid port difficult. This could result in inadequate suction and cause a delay in patient care.
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-1291-2025. 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.