OVERLOOKED

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Class IIOngoing

Cook Incorporated recalls Williams Cystoscopic Injection Needles

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
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 during manufacturing. Potential events that may occur as a result of this issue include increased procedural time and inadequate treatment.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Where
Florida, Illinois, New Mexico, Texas, Washington
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99875…

Products

  1. 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

    Codes/lots: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548XQuantity: 97 unitsRecall no. Z-0163-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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