Recall Z-2591-2025— C.R. Bard Inc

Name: FDA recall Z-2591-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2025-07-17. It names one FDA 510(k) clearance: K040658. Product: SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216. Reason: 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.

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-07-17
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K040658 — BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.·cleared 2004-09-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.