FDA Device recall Z-0908-2026
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 by C R Bard, citing labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0908-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-06 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C R Bard |
| Distribution | US |
Product
BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
Reason
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Identifiers
| code_info | Lot# NGJU4328/UDI: (01)00801741015922 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0908-2026%22
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