C.R. Bard Inc: Device Recall
Recall #Z-0905-2026 · 11/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0905-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- C.R. Bard Inc
- Status
- Ongoing
- Date Initiated
- 11/06/2025
- Location
- Covington, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 116 units
Reason for Recall
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
Product Description
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, IA, IN, KY, LA, MA, MD, MI, MO, ND, NJ, NY, OH, PA, SD, VA, WA, WI and the countries of Canada, EMEA (Belgium, Denmark, Slovakia, Spain, Turkey, United Kingdom, MENA (Jordan), S Africa), Greater Asia (China).
Other Recalls by C.R. Bard Inc
- Class II: Risk 11/06/2025
- Class II: Risk 11/06/2025
- Class II: Risk 11/06/2025
- Class II: Risk 07/17/2025
- Class II: Risk 07/17/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.