Lower risk Medical device recall · FDA · Published September 16, 2026

Cook Cystoscopic Needles Recall: Risk of Inadequate Treatment

Cook Incorporated recalls 97 cystoscopic injection needles (Lot 16613606, 16951548, 16951548X) due to potential misalignment causing inadequate treatment. Affected units sold in US states FL, IL, NM, TX, WA and Canada, France, Germany, Italy, Spain, Switzerland.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0163-2027Medical device Cook Incorporated ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

Cook Incorporated recalls 97 cystoscopic injection needles that may not seat correctly, leading to longer procedures or ineffective treatment. This recall affects specific lots sold in the US and several international countries. Read more at govinfonow.com/recall/1764684-cook-incorporated-recalls-williams-cystoscopic-injection-needles-used-for-cystoscopic.

Source Summary by GovInfoNow · govinfonow.com/recall/1764684-cook-incorporated-recalls-williams-cystoscopic-injection-needles-used-for-cystoscopic · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0163-2027

Cite this page

“Cook Cystoscopic Needles Recall: Risk of Inadequate Treatment.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764684-cook-incorporated-recalls-williams-cystoscopic-injection-needles-used-for-cystoscopic. Based on FDA recall #Z-0163-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0163-2027%22&limit=1).

The FDA announced on Sept. 16, 2026, that Cook Incorporated is recalling Williams Cystoscopic Injection Needles due to a manufacturing defect in the Luer lock adapter. The agency classified the recall as Class II.

How to tell if you have it

Brand: Cook Incorporated
Product: Williams Cystoscopic Injection Needles
Reference Part Number: 090001-S26
Order Number (GPN): G16112
UDI-DI: 00827002161122
Lot Numbers: 16613606, 16951548, 16951548X

The hazard

The female Luer lock adapter component may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. This defect could result in increased procedural time and inadequate treatment, according to the FDA.

Context

GovInfoNow's records show Cook Incorporated has issued 16 other recalls since May 5, 2022. Recent Cook recalls include Beacon Tip Centimeter Sizing Catheters (April 2, 2026), Strange Bile Duct Stone Sets (March 5, 2026), and Flexor Check-Flo Introducers (Nov. 26, 2025). Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Devices (March 3, 2026), Medline Medical Procedure Kits (May 4, 2026), and B Braun Spinocan Spinal Needle Kits (May 6, 2026).

How to tell if you have this one

Check for Lot Numbers 16613606, 16951548, or 16951548X on the packaging. These needles were sold in the US states of Florida, Illinois, Nevada, Texas, and Washington, and in Canada, France, Germany, Italy, Spain, and Switzerland.

Brand
Cook Incorporated
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for Lot Numbers 16613606, 16951548, or 16951548X on the packaging.

Where it went and when

Where it was distributed

Distributed in 5 states, and outside the U.S.

FDA distribution: “US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Illinois, New Mexico, Texas, Washington.

Recall timeline

FDA published this recall 35 days after the firm started it.

Sep 16, 2026Firm started the recall
Oct 15, 2026FDA classified it Class II
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/1764684-cook-incorporated-recalls-williams-cystoscopic-injection-needles-used-for-cystoscopic">Cook Cystoscopic Needles Recall: Risk of Inadequate Treatment (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0163-2027 (September 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0163-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.