Recall Z-0163-2027 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cook Incorporated
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
| Date | Oct 15, 2026 (initiated Sep 16, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| 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 b |
| Quantity | 97 units |
| Distribution | US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171602 | Williams Cystoscopic Injection Needle Cook Incorporated, Jul 28, 2017 |