Device recall
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
- Recall number
- Z-0163-2027
- Event id
- 99875
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cook Incorporated
- Report date
- Oct 21, 2026
- Posted
- Oct 15, 2026
- Initiated
- Sep 16, 2026
- Center classification date
- Oct 15, 2026
- Product code
- FBK
- Device type
- Endoscopic Injection Needle, Gastroenterology-Urology
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 97 units
- Code info
- UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
- Distribution
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K171602
- Location
- Bloomington, IN, United States