Use cautionMedical device recall · FDA · Published June 18, 2025
C.R. Bard Recalls Foley Catheters with Possible Obstruction Risk
C.R. Bard recalls specific models of temperature-sensing silicone catheters due to potential lumen obstruction causing urinary retention and pain. Affected units include certain 5cc balloon models with specific reference numbers.
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Take action
Contact the company
📍Recalling firmC.R. Bard Inc8195 Industrial Blvd Ne · Covington, GA 30014-1497
✎ GovInfoNow plain-language explainer
C.R. Bard is recalling certain temperature-sensing silicone Foley catheters that may have an obstructed lumen, preventing proper urine drainage and causing pain, bladder dysfunction, or kidney issues. Patients using these catheters should contact Bard for a replacement. Read more at govinfonow.com/recall/52025-c-r-bard-recalls-foley-catheters-with-possible-obstruction-risk.
“C.R. Bard Recalls Foley Catheters with Possible Obstruction Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52025-c-r-bard-recalls-foley-catheters-with-possible-obstruction-risk. Based on FDA recall #Z-2462-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2462-2025%22&limit=1).
C.R. Bard Inc recalled Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon units due to a potential obstructed lumen, the FDA said on June 18, 2025.
SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A
Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S
Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
The hazard
The Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Context
GovInfoNow's records show C.R. Bard Inc has 26 other recalls on record since June 2, 2017. Other recent recalls of similar products include Bardex Pericare Wipes in Foley Catheter Trays May Contain Contamination (June 25, 2026), C.R. Bard Silastic Foley Catheters Recall: Stain on Surface (April 23, 2026), and BD InLay Optima Ureteral Stent Kit: Labeling Discrepancy Risk (Nov. 6, 2025).
How to tell if you have this one
Check for the product names and reference numbers listed in the recall notice. The affected catheters include Bardex Lubri-Sil I.C. 400-series models with specific reference codes such as 119314, 29000J14, and 29030J14S.
Brand
C.R. Bard
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the product name and reference numbers on the catheter packaging or label to confirm if it is affected.
Contact Bard for Replacement
Reach out to C.R. Bard directly to arrange for a replacement catheter if the product is confirmed to be affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Florida, Georgia, Hawaii, Indiana, Iowa, Maryland, Massachusetts, Minnesota, Oklahoma, Oregon, Pennsylvania, West Virginia.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Do I need to stop using this catheter immediately?
No, but if you have symptoms like pain or difficulty urinating, contact Bard immediately. The recall does not require immediate discontinuation but prompt replacement if affected.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2462-2025 (June 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2462-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.