Lower risk Medical device recall · FDA · Published July 17, 2025

C.R. Bard SureStep Foley Tray System Recall: Incorrect Inserts Risk Infection

C.R. Bard recalls SureStep Foley Tray System with incorrect inserts that may cause infection due to material mix-ups. Affected units have REF: A303316A and Lot#NGJX6399.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2589-2025Medical device C.R. Bard ›

Lower-risk recall

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Take action

Contact the company

Recalling firmC.R. Bard Inc8195 Industrial Blvd Ne · Covington, GA 30014-1497

✎ GovInfoNow plain-language explainer

C.R. Bard is recalling SureStep Foley Tray Systems with incorrect inserts that could cause infections. Using these trays might lead to allergic reactions or infections because the materials are mislabeled. Read more at govinfonow.com/recall/51775-c-r-bard-surestep-foley-tray-system-recall-incorrect-inserts.

Source Summary by GovInfoNow · govinfonow.com/recall/51775-c-r-bard-surestep-foley-tray-system-recall-incorrect-inserts · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2589-2025

Cite this page

“C.R. Bard SureStep Foley Tray System Recall: Incorrect Inserts Risk Infection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51775-c-r-bard-surestep-foley-tray-system-recall-incorrect-inserts. Based on FDA recall #Z-2589-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2589-2025%22&limit=1).

The FDA announced on July 17, 2025, that C.R. Bard Inc is recalling SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray (REF: A303316A) due to incorrect inserts that may cause infection or allergic reactions. The agency classified the Class II recall as voluntary.

How to tell if you have it

Brand: C.R. Bard
Product: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray
REF: A303316A
Lot#: NGJX6399
Quantity: 4,300 units

The hazard

The Foley catheter trays contain incorrect inserts, leading users to mistake silicone for natural rubber latex or vice versa. This error may cause infection and/or local and/or systemic allergic reaction.

Context

GovInfoNow's records show C.R. Bard Inc has 26 other recalls on record since June 2, 2017. Recent brand recalls include the June 25, 2026 C.R. Bard Pericare Wipes Recall for contamination risk and the April 23, 2026 C.R. Bard Silastic Foley Catheters Recall for surface stains. Other recent recalls of similar products include the Nov. 6, 2025 Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall and the May 21, 2026 Bard THORA/ PARA TRAY Recall.

How to tell if you have this one

Check for the model reference A303316A and lot number NGJX6399 on the tray. The product is sold under C.R. Bard's SureStep Foley Tray System.

Brand
C.R. Bard
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.

Recall number	Product, codes & lots	Quantity
Z-2589-2025	SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A; Lot#NGJX6399	4,300
Z-2590-2025	SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A; Lot# NGJY3685	4,300
Z-2591-2025	SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216; Lot# NGJX4320	3670

Based on the official FDA remedy

What to do — step by step

Check Insert Material
Verify the insert material matches the label: it should be silicone hydrogel with antimicrobial coating, not natural rubber latex.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 33 states.

FDA distribution: “US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 2 months after the firm started it.

Jul 17, 2025Firm started the recall
Sep 18, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Could this cause serious injury?

The recall states it may cause infection or allergic reactions, but not serious injury in normal use.

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Link to this recall

<a href="https://govinfonow.com/recall/51775-c-r-bard-surestep-foley-tray-system-recall-incorrect-inserts">C.R. Bard SureStep Foley Tray System Recall: Incorrect Inserts Risk Infection (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2589-2025 (July 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2589-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.