Recall Z-0906-2026 ยท FAD Stent, Ureteral
C.R. Bard Inc
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
| Date | Dec 11, 2025 (initiated Nov 6, 2025) |
| Status | Open, Classified |
| Reason | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. |
| Root cause | Under Investigation by firm |
| Action | On Nov. 6, 2025, BD issued a "Urgent Medical Device Recall" Notification to consignees via regional courier service or e-mail. In addition to informing consignees about the recall, BD ask consignees to take the following actions: 1. Immediately Discontinue Use. 2. Please check all inventory locations within your institution for affected BD (C.R. Bard, Inc.) product listed in the Affected Product section below. 3.Immediately quarantine and discard all devices within your facility s control per your facility s procedures. 4. Share this notice with any users of the product within your facili |
| Quantity | 4350 units |
| Distribution | 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). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043193 | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. Bard, Inc., Dec 7, 2004 |