Agency classClass IIOur severity:High FDA (Devices)·Z-2154-2024·Announced 2024-06-26

Bard Foley Catheter Trays Recalled for Temperature Display Malfunction

C.R. Bard Inc is recalling 6,420 Foley catheter trays nationwide because some devices may not display temperature readings or may display erratic readings. The malfunction could affect patient monitoring.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a functional defect in temperature monitoring equipment—a risk-of-harm product where injury has not yet been reported, supporting a High severity rating.

Plain-English summary

C.R. Bard Inc is recalling 6,420 units of two Foley catheter tray products nationwide: the Bard Medical SureStep Foley Tray System (16 Fr., Catalog #A319416AM) and the Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray (16 Fr., Catalog #319416AM). These medical devices are used for drainage, collection, and measurement of urine.

Some devices in this recall may function incorrectly, resulting in either no temperature display or erratic temperature readings. The temperature-sensing feature is designed to support infection control monitoring.

The recalled devices have the following lot numbers and expiration dates: Bard Medical SureStep Foley Tray System Lot #NGHZ1757 (expires 31 January 2026) and Bardex IC Complete Care Lot #NGHX2932 (expires 31 May 2025). Distribution was nationwide.

Consumers and healthcare providers should discontinue use of affected units and contact C.R. Bard Inc or their healthcare provider for guidance on replacement or alternative products.

The recalled product

Product: 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…
Manufacturer: C.R. Bard Inc
Category: Medical Device — Foley Catheter Tray
Hazard: temperature-sensor-malfunction
display-failure
erratic-readings
Affected units: 6,420

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

SureStep Foley Tray System - Lot #NGHZ1757
exp. 31Jan2026
UDI-DI 00801741073861 (eaches)
Lot #NGHX2932
exp. 31May2025
UDI-DI 00801741024450 (each)
10801741024457 (case).

Distribution

Distributed nationwide across the United States.

Same manufacturer · C.R. Bard Inc

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C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
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C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
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C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
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Same hazard · temperature sensor malfunction