BD InLay Optima Ureteral Stent Kit Size: 4 — Class II medical device recall Z-0906-2026
Ongoing recall by C.R. Bard Inc, reported 2025-12-17, distributed nationwide. Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
| Recall number | Z-0906-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2025-11-06 |
| Classified | 2025-12-11 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CN, DK, ES, GB, JO, SK, TR |
| Quantity | 4,350 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00801741015687 |
| Lot numbers | NGJU4181 |
| Model numbers | 788426 |
Product
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
Reason for recall
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
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-0906-2026. 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.