TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
- Why
- 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.
- Distributed
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
- Company
- Cook Incorporated
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0163-2027 · retrieved 15 October 2026
Read the official notice