Class 2 Device Recall Williams Cystoscopic Injection Needle

• Date Initiated by Firm: September 16, 2026
• Date Posted: October 15, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0163-2027
• Recall Event ID: 99875
• 510(K)Number: K171602
• Product Classification: endoscopic injection needle, gastroenterology-urology - Product Code FBK
• Product: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112
• Code Information: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
• FEI Number: 1820334
• Recalling Firm/ Manufacturer: Cook Incorporated; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-339-2235
• Manufacturer Reason for Recall: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/16/26 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market. Additionally, an investigation has been opened to determine the appropriate actions to prevent reoccurrence of a similar issue. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
• Quantity in Commerce: 97 units
• Distribution: US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FBK