Z-0163-2027

Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and...

Name: Z-0163-2027 Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and...
Creator: Cook Incorporated
Published: 2026-09-16
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2026-09-16 / Open, Classified

FDA source

Recall record

Recall number: Z-0163-2027
Status: Open, Classified
Initiated: 2026-09-16
Posted: 2026-10-15
Recalling firm: Cook Incorporated
Product: 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
Product code: FBK Endoscopic Injection Needle, Gastroenterology-Urology
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.
FDA root cause: Under Investigation by firm
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 9/16/26 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market. Additionally, an investigation has been opened to determine the appropriate actions to prevent reoccurrence of a similar issue. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Quantity in commerce: 97 units
Distribution: US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Product codes and lots: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X

Product code FBK

K171602Class IIWilliams Cystoscopic Injection NeedleCook Incorporated / cleared 2017-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)