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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

SureStep and Bard Foley Catheter Trays Recalled for Incorrect Labeling

Agency Publication Date: September 18, 2025
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Summary

C.R. Bard Inc. is recalling approximately 12,270 SureStep and Bard Foley Catheter Trays because they contain incorrect product inserts regarding the catheter material and coatings. These errors may lead a healthcare provider to believe a catheter is made of silicone when it is actually natural rubber latex, or that it contains a different type of antimicrobial or infection control coating than provided. The recall affects SureStep Foley Tray Systems and Bard Lubri-Sil models distributed to healthcare facilities across 33 states.

Risk

Patients with latex sensitivities may suffer from localized or systemic allergic reactions if a latex catheter is mistakenly used. Additionally, confusion regarding the specific antimicrobial or infection control coating can lead to ineffective treatment and an increased risk of urinary tract infections.

What You Should Do

  1. This recall involves Bard and SureStep Foley Catheter Tray Systems, including Bardex I.C. and Lubri-Sil models with catalog numbers A303316A, A303414A, and A942216.
  2. Affected units can be identified by checking for lot numbers NGJX6399, NGJY3685, or NGJX4320 printed on the product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately to avoid the risk of patient injury or infection.
  4. Contact the manufacturer, C.R. Bard Inc, or your distributor to arrange for the return, replacement, or correction of any affected trays you have in stock.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this medical device recall.

Your Remedy Options

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

Affected Products

Product: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray
Model / REF:
A303316A
Lot Numbers:
NGJX6399

Recall Number: Z-2589-2025

Product: SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray
Model / REF:
A303414A
Lot Numbers:
NGJY3685

Recall Number: Z-2590-2025

Product: SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray
Model / REF:
A942216
Lot Numbers:
NGJX4320

Recall Number: Z-2591-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97273
Status: Active
Manufacturer: C.R. Bard Inc
Manufactured In: United States
Units Affected: 3 products (4,300; 4,300; 3670)
Distributed To: North Carolina, Florida, New York, Massachusetts, Minnesota, Texas, California, Ohio, Michigan, Washington, New Jersey, Illinois, Idaho, South Carolina, Indiana, Oklahoma, Oregon, Alabama, Virginia, Hawaii, Missouri, Mississippi, Maryland, Arizona, Kentucky, Georgia, Iowa, Colorado, New Mexico, Pennsylvania, Maine, Utah, Nebraska

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 Β· 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.