Reported Oct 21, 2026 · Ongoing · Updated Oct 26, 2026
Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- 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
- Lot codes and dates
- UDI-DI00827002161122
- Lot Numbers
166136061695154816951548X
- Amount recalled
- 97 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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