Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2589-2025 — SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

U.S. FDA — Device Enforcement · United States · 2025-07-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2589-2025
Date of alert
2025-07-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
C.R. Bard Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.