Class II — Cook Incorporated
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 97 units |
| Distribution | US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland. |
| Initiated | 2026-09-16 |
| Classified | 2026-10-15 |
| Recall number | Z-0163-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Incorporated (Z-0163-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99875/
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