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.
What this means for you
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
- Hazard
- temperature-sensor-malfunction
- display-failure
- erratic-readings
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.
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