Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brand
- CR 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
- CR Bard
- Product type
- Foley Catheter Tray
- Model numbers
- A942216
- 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 clinical settings to organize and prepare catheter insertions. The SureStep Tray System is designed for efficient workflows in patient care.
Why This Is Dangerous
Incorrect inserts create a material mismatch risk. If latex is present where silicone is expected, patients may suffer infections or allergic reactions.
Industry Context
This recall is not described as part of a broader industry pattern in the release.
Real-World Impact
Hospitals and clinics may need to halt use of affected trays, replace stock, and refabricate procedures to avoid infection or latex allergy reactions.
Practical Guidance
How to identify if yours is affected
- 1. Locate trays labeled A942216
- 2. Inspect inserts to confirm material as listed in the recall notice
- 3. Compare labeling to manufacturer guidance
- 4. Segregate affected stock from usable inventory
- 5. Follow manufacturer recall instructions for replacement or remediation
Where to find product info
CR Bard recall communications and FDA enforcement page; contact the manufacturer for instructions
What timeline to expect
Typically 4-8 weeks for refunds or replacements in recalls; exact timelines vary by facility and replacement stock availability
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer
- Escalate to hospital risk management or regulatory affairs
- File a report with the appropriate regulatory body if unresolved
How to prevent similar issues
- Verify material labeling on all Foley catheter trays before use
- Prefer vendors with clear material disclosures and antimicrobial/coating specifications
- Maintain an updated inventory of high-risk medical trays and segregate any items with unclear labeling
Documentation advice
Keep recall notices, correspondence with manufacturer, batch/lot numbers, and inventory segregation records as part of the incident file
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Product Details
Model: A942216 Origin: United States Sold: Nationwide distribution in the U.S. Quantity: 3,670 units Brand: CR Bard Product: SureStep Foley Tray System, Lubri-Sil Foley Catheter Tray, REF A942216 Status: Active recall as of 2025-09-24 Notes: Specific dates of sale not provided; recall distributed nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3,670 units recalled nationwide
- Inserts may be natural rubber latex or silicone hydrogel with antimicrobial coating, mislabeling as/
- Foley tray mislabeling could cause infection or allergic reaction
- Recall date: 2025-07-17; Status: ACTIVE
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Safety Guide
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