Class II U.S. Food and Drug Administration

C.R. Bard Inc Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 recall: Labeling discrepancy; Ureteral stent actual size may not match the actual

Recall published 10 months ago

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Labeling discrepancy; Ureteral stent actual size may not match the actual product label.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0905-2026
Published
December 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
C.R. Bard Inc
Product type
Medical devices
Units affected
116 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot# NGJU4163/UDI: (01)00801741015403
UPC codes
00801741015403

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00801741015403

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • NGJU4163
  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 787614 — Lot# NGJU4163
  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

C.R. Bard Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: C.R. Bard Inc — 8195 Industrial Blvd Ne, Covington, GA, 30014-1497

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was C.R. Bard Inc medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00801741015403; lot code NGJU4163, UDI; model number 787614 — Lot# NGJU4163, UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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