The Recall Desk
Severity pendingFDA (Devices)·Z-0905-2026·Announced 2025-12-17

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614

Pending LLM rewrite. Source: FDA_DEVICE Z-0905-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

The recalled product

Product
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Manufacturer
C.R. Bard Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot# NGJU4163/UDI: (01)00801741015403

Distribution

Distributed nationwide across the United States.