C.R. Bard Inc: Medical Device Recall in 2024 - (Recall #: Z-2154-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.

Product Classification:

Class II

Date Initiated: May 9, 2024

Date Posted: June 26, 2024

Recall Number: Z-2154-2024

Event ID: 94722

Reason for Recall:

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

Status: Ongoing

Product Quantity: 6,420 devices

Code Information:

SureStep Foley Tray System - Lot #NGHZ1757, exp. 31Jan2026, UDI-DI 00801741073861 (eaches); 10801741073868 (case). Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray, Lot #NGHX2932, exp. 31May2025, UDI-DI 00801741024450 (each); 10801741024457 (case).

Distribution Pattern:

Distribution was nationwide. There was no government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated