Quick Facts at a Glance
- Recall Date
- July 17, 2025
- Hazard Level
- HIGH
- Brand
- C.R. Bard
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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
- Model numbers
- NGJY3685
- Sold at
- Unknown
- 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 hospitals for sterile preparation of catheters. They ensure protected insertion workflows and infection control.
Why This Is Dangerous
Mismatched inserts can misrepresent material properties, potentially causing infection or allergic reactions when used in catheter procedures.
Industry Context
This recall is not identified as part of a broader industry pattern in the provided data.
Real-World Impact
Represents a high-risk scenario for hospital procurement and patient safety, with urgent need for facility action and proper documentation.
Practical Guidance
How to identify if yours is affected
- Check REF on the tray: A303414A
- Inspect Lot number: NGJY3685
- Confirm distribution was nationwide in the US
Where to find product info
Product labels and packing slips; recall letter from Bard; FDA enforcement page
What timeline to expect
Replacement or refund timelines not specified; expect guidance from Bard or FDA notices within weeks
If the manufacturer is unresponsive
- Escalate within hospital administration
- Document all contact attempts
- File complaint with hospital incident reporting system
How to prevent similar issues
- Verify material inserts before tray use
- Adopt standardized vendor verification for all sterile trays
- Maintain up-to-date recall monitoring for medical devices
Documentation advice
Keep copy of the recall letter, batch/lot numbers, and any replacements or refunds.
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Product Details
Model: Lot# NGJY3685. Quantity: 4,300 units. Distribution: US nationwide. REF: A303414A. Category: Foley catheter trays used in infection control. Manufacturer: C.R. Bard. Recall Date: 2025-07-17. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported in the available recall notice.
Key Facts
- Class II recall
- Domestic distribution nationwide in the US
- Model/lot: NGJY3685
- Warning about incorrect inserts posing infection/allergic risk
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Safety Guide
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