FDA Medical devices recall ·
Bard InLay Optima Size: 6 Fr recall
- Recall number
- Z-0905-2026
- Date
- (initiated November 6, 2025)
- Company / brand
- C.R. Bard Inc
8195 Industrial Blvd Ne, Covington, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 116 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
Why was it recalled?
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# NGJU4163/UDI: (01)00801741015403
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).
States: Arizona California Colorado Florida Georgia Iowa Indiana Kentucky Louisiana Massachusetts Maryland Michigan Missouri North Dakota New Jersey New York Ohio Pennsylvania South Dakota Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0905-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.