Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brand
- C.R. Bard
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- C.R. Bard
- Product type
- Foley catheter tray system
- Model numbers
- REF: A303316A
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 17, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C.R. Bard Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
Foley catheter trays are used in medical procedures to prepare and support catheter placement. The SureStep tray line includes infection-control features intended for sterile use.
Why This Is Dangerous
If inserts are incorrect, the tray could misrepresent material properties, potentially exposing latex or silicone materials and coatings that do not meet stated expectations. This misrepresentation can lead to infection or allergic reactions.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall could affect patient safety in clinical settings and may require facilities to audit stock and training to prevent infections.
Practical Guidance
How to identify if yours is affected
- Check tray packaging for model REF: A303316A and product name SureStep Foley Tray System Bardex I.C. Complete Care.
- Compare inserts to labeling to confirm material composition.
- Review recall notification for instructions and contact Bard or provider if uncertain.
Where to find product info
FDA enforcement page Z-2589-2025 and Bard recall communications provide official identification details.
What timeline to expect
Recall processing and replacement or refunds follow Bard's recall timeline; typically weeks to months depending on facility stock.
If the manufacturer is unresponsive
- Escalate to hospital risk management or contract compliance.
- File a complaint with consumer protection if Bard does not respond within a reasonable period.
How to prevent similar issues
- Verify material composition before use in any tray.
- Keep updated recall communications and confirm model numbers prior to use.
- Establish a process for inspecting supplier documentation for all tray components.
Documentation advice
Retain recall letter, document serial/model numbers, dates of procurement, and communications with Bard or suppliers.
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Product Details
Model: REF: A303316A. Sold nationwide in the United States. Quantity: 4,300 units. Price: Unknown. Brand: C.R. Bard. Product family: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 4300 units recalled nationwide
- Model REF: A303316A
- Incorrect inserts may cause infection or allergic reactions
- Recall status: ACTIVE
- FDA enforcement link: Z-2589-2025
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Safety Guide
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