Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bard Medical SureStep Foley Tray System Recalled by C.R. Bard Inc Due to Some of the devices may function incorrectly resulting...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact C.R. Bard Inc directly.
Affected Products
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.
Quantity: 6,420 devices
Why Was This Recalled?
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About C.R. Bard Inc
C.R. Bard Inc has 65 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report