Cook Medical Williams Cystoscopic Injection Needle Recalled 2026: Health Canada

Cook Medical has recalled a lot of its Williams Cystoscopic Injection Needle in Canada after determining that a connector component may have been assembled out of specification. Health Canada published the notice on 2026-09-23 under identification number RA-82666, classifying it as a Type II health product recall with a recall date of 2026-09-16.

The alert is directed at the healthcare audience, not at retail shoppers. It concerns a single model and a single lot of a urology and gastroenterology medical device, and it asks anyone with questions to contact the manufacturer.

Recalled Products at a Glance

• Product: Williams Cystoscopic Injection Needle
• Model or catalogue number: 090001-S26
• Lot or serial number: 16951548
• Manufacturer: Cook, Incorporated, 750 Daniels Way, Bloomington, Indiana, United States, 47404
• Category: Health products – Medical devices – Gastroenterology and urology
• Recall class: Type II
• Recall date: 2026-09-16
• Health Canada identification number: RA-82666

Only one lot appears in the notice. Health Canada’s listing does not state how many units are involved or the dates during which the affected product was distributed, so facilities should rely on the lot and model numbers above rather than on purchase dates alone.

What Triggered the Recall

According to the notice, Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. The specific concern involves the female luer lock adapter component, which may not have been correctly seated because of misalignment and inadequate torquing during manufacturing.

Health Canada categorizes the issue as a medical device performance problem. That places the concern on how the device was assembled and how it may perform. The published notice does not describe any injuries, complaints or adverse events linked to the affected lot, and it does not spell out the clinical consequences that could follow if the adapter were not properly seated.

Because those details are not in the source, this report does not speculate about outcomes. Clinicians and biomedical or supply staff who want more detail on the defect or on how it may affect procedures should go to the manufacturer directly, as the notice advises.

Who Should Be Concerned

The audience listed for this alert is healthcare. That generally means hospitals, clinics and other facilities that stock or use cystoscopic injection needles, as well as the professionals who handle those supplies. Members of the public are not the target of the notice, and no consumer refund program is described.

The notice does not list provinces or territories, nor does it name distributors or facilities that received the lot. Health Canada published it on its recalls and safety alerts site with Canada listed as the location.

How to Respond to This Recall

The only action Health Canada lists is to contact the manufacturer if you require additional information. Beyond that, the notice does not publish a return, replacement or refund procedure, and it does not include a phone number or email address for Cook Medical. The company’s address is given as Cook, Incorporated, 750 Daniels Way, Bloomington, Indiana, United States, 47404.

Facilities that use this product may want to compare their inventory against model number 090001-S26 and lot 16951548, then follow their own internal recall and quality procedures while they seek guidance from the manufacturer. Patients who have questions about a past or upcoming procedure should raise them with their treating clinician rather than trying to identify the device themselves.

Regulatory Response

Health Canada, through its medical devices area, published the recall on 2026-09-23, one week after the listed recall date of 2026-09-16. Type II is the middle of Health Canada’s three recall classes. The notice was last updated on 2026-09-23 and names Cook, Incorporated as the company involved.

Readers can subscribe to Health Canada’s email notifications for new and updated recalls and safety alerts, and can report a health or safety concern through the department’s reporting page. Because recall notices carry a last-updated date, healthcare providers should check the official Health Canada page for any revisions.