Cook Incorporated recalls Williams Cystoscopic Injection Needles
- Recalling company
- Cook Incorporated
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Sep 16, 2026
- Reported
- Oct 21, 2026
- Distribution
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
- Status
- Ongoing
- Quantity
- 97 units
- Lot / codes
- UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
- Company location
- Bloomington, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0163-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0163-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.