SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, RE...

FDA Device Recall #Z-2590-2025 — Class II — July 17, 2025

Recall Summary

Recall Number Z-2590-2025
Classification Class II — Moderate risk
Date Initiated July 17, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm C.R. Bard Inc
Location Covington, GA
Product Type Devices
Quantity 4,300

Product Description

SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

Reason for 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

Distribution Pattern

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.

Lot / Code Information

Lot# NGJY3685

Other Recalls from C.R. Bard Inc

Recall # Classification Product Date
Z-2226-2026 Class II Silastic Foley Catheters Silastic Brand Foley ... Apr 23, 2026
Z-0905-2026 Class II Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral... Nov 6, 2025
Z-0907-2026 Class II BD InLay Optima Ureteral Stent Kit Size: 6 Fr. ... Nov 6, 2025
Z-0908-2026 Class II BD InLay Optima Ureteral Stent Kit Size: 8 Fr. ... Nov 6, 2025
Z-0906-2026 Class II BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr... Nov 6, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.