← FDA ENFORCEMENT
Z-0163-2027Class II

Cook Incorporated

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Cook Incorporated
Product type
Device
Status
Ongoing
Report date
2026-10-21
Distribution
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Firm state
IN
Product quantity
97 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

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.

Product description

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

Code / lot info

UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X

Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →