FDA recall, , Moderate risk
Cook Williams Cystoscopic Injection Needles
Williams Cystoscopic Injection Needles may have a misaligned Luer lock adapter, increasing procedural time and causing inadequate treatment.
Summary by Recall Canary from the FDA notice
What happened
Cook Incorporated is recalling 97 Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall. 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.
The recall began September 16, 2026, and was added to the FDA's Enforcement Report on October 15, 2026. The devices were distributed in US States: FL, IL, NM, TX, WA, and in Canada, France, Germany, Italy, Spain, and Switzerland.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
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
- UDI-DI
- 00827002161122
- Lot code
- 16613606
- 16951548
- 16951548X
Recall details
- Company began the recall
- Sold in
US States: Florida, Illinois, New Mexico, Texas, Washington. Canada, France, Germany, Italy, Spain, Switzerland.
- Company
- Cook Incorporated
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99875
- Recall number
- Z-0163-2027
- Quantity recalled
- 97 units
All recalls from Cook Incorporated
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
