# FDA recall Z-2591-2025

> **C.R. Bard Inc** · Class II · device recall initiated 2025-07-17.

## Product

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

## Distribution

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.

## Key facts

- **Recall number:** Z-2591-2025
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-17
- **Report date:** 2025-09-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Covington, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2025

## Citation

> AI Analytics. FDA recall Z-2591-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2591-2025. Source: US FDA. Licensed CC0.

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