Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall,
Summary
The FDA issued a Class II for Williams Cystoscopic Injection Needles, used for cystoscopic injection into the by Cook Incorporated. Reason: The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing duri.
Details
Source
Device Recall
External ID
Z-0163-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
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
Lot/Code Info: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
Quantity Affected: 97 units
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.
Distribution
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-16
Company
Bloomington, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Cook Incorporated has 89 FDA actions in our database, including 86 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 89 FDA actions in our database, including 86 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0163-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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