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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Bard and BD InLay Optima Ureteral Stent Kits Recalled for Labeling Error

Agency Publication Date: December 11, 2025
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Summary

C.R. Bard Inc is recalling 4,698 Bard and BD InLay Optima Ureteral Stent Kits because the actual size of the stent inside the package may not match the size listed on the label. This labeling discrepancy means healthcare providers could unknowingly attempt to use an incorrectly sized stent during a medical procedure. The affected products were distributed to hospitals and medical facilities worldwide between November 2025 and the present.

Risk

Using a stent of the wrong size can result in surgical delays while a replacement is found or improper drainage of the kidney. In some cases, it could lead to physical injury during insertion or removal if the physician is unaware that the device size differs from the expected dimensions.

What You Should Do

  1. This recall affects Bard and BD InLay Optima Ureteral Stent Kits with catalog numbers 787614 (Lot NGJU4163), 788426 (Lot NGJU4181), 788630 (Lot NGJU4327), and 78826 (Lot NGJU4328).
  2. Stop using the recalled device immediately to avoid potential surgical complications.
  3. Contact C.R. Bard Inc or your medical supply distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  4. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Bard InLay Optima Ureteral Stent Kit (6 Fr. x 14 cm)
Model / REF:
787614
Lot Numbers:
NGJU4163
UDI:
00801741015403

Recall #: Z-0905-2026; Quantity: 116 units

Product: BD InLay Optima Ureteral Stent Kit (4.7 Fr. x 26 cm)
Model / REF:
788426
Lot Numbers:
NGJU4181
UDI:
00801741015687

Recall #: Z-0906-2026; Quantity: 4350 units

Product: BD InLay Optima Ureteral Stent Kit (6 Fr. x 30 cm)
Model / REF:
788630
Lot Numbers:
NGJU4327
UDI:
00801741015786

Recall #: Z-0907-2026; Quantity: 116 units

Product: BD InLay Optima Ureteral Stent Kit (8 Fr. x 26 cm)
Model / REF:
78826
Lot Numbers:
NGJU4328
UDI:
00801741015922

Recall #: Z-0908-2026; Quantity: 116 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97985
Status: Active
Manufacturer: C.R. Bard Inc
Sold By: Hospitals; Medical Supply Distributors
Manufactured In: United States
Units Affected: 4 products (116 units; 4350 units; 116 units; 116 units)
Distributed To: Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Dakota, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Virginia, Washington, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.