# FDA recall Z-3119-2026

> **C.R. Bard Inc** · Class II · device recall initiated 2026-06-25.

## Product

Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300314AC UDI-DI code: 00801741143243  SureStep" Foley Tray System Bardex¿ IC Complete Care¿ REF: A300316AC UDI-DI code: 00801741143250   SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care¿ REF: A319516AMC UDI-DI code: 00801741143472  SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800366C UDI-DI code: 00801741143571  SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897514C UDI-DI code: 00801741074011¿  SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A897516C UDI-DI code: 00801741143595  SureStep" Foley Tray System Bard¿ Silicone Foley Catheter Tray REF: A902114C UDI-DI code: 00801741144325  ***** SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A300416AC UDI code: 00801741143281	10801741143288  SureStep" Foley Tray System Bardex¿ IC Complete Care REF: A303314AC UDI code: 00801741143304	10801741143301  SureStep" Foley Tray System Lubri-Sil¿ IC Complete Care REF: A319514AMC UDI code: 00801741143465	10801741143462  SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800061C UDI code: 00801741144172	10801741144179  SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800065C UDI code: 00801741144202	10801741144209  SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800360C UDI code: 00801741143519	10801741143516  SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF:A800361C UDI code: 00801741143526	10801741143523  SureStep" Foley Tray System Bard¿ Lubricath¿ Foley Catheter Tray REF: A800362C UDI code: 00801741143540	10801741143547  SureStep" Foley Tray System Bard¿ Lubricath Foley REF: A800365C UDI code: 00801741143564	10801741143561     For urological use only, Intended for use in the drainage and/or collection and/or measurement of urine.

## Reason for recall

Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

## Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Costs Rica, Guatemala, Mexico, Saudi Arabia, and United Arab Emirates.

## Key facts

- **Recall number:** Z-3119-2026
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-25
- **Report date:** 2026-09-16

- **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-3119-2026

## Citation

> MORVS. FDA recall Z-3119-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3119-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*