FDA Medical Device Recalls (openFDA)
C.R. Bard Inc: BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Recall number
- Z-0907-2026
- Recalling firm
- C.R. Bard Inc
- Product
- BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
- Status
- Open, Classified
- Initiated
- 2025-11-06
- Posted
- 2025-12-11
- Terminated
- not on file
- 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 facilities to ensure they are also aware of this Medical Device Recall (Correction). 5.If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. 6.Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement ) 7. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program
- Quantity
- 116 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).
- Lot, serial or model codes
- Lot# NGJU4327/UDI:(01)00801741015786
- 510(k) numbers
- ["K043193"]
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28