Class IIDeviceOngoing

Cook Incorporated

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

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.

Details

Recall number: Z-0163-2027
Event ID: 99875
Recall initiated: Sep 16, 2026
Classified: Oct 15, 2026
Reported: Oct 21, 2026
Quantity: 97 units
Distribution: US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Initiated by: Voluntary: Firm initiated
Firm location: Bloomington, IN, United States
Lot / code info: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X