{"recall":{"id":"fda-device-99875","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Cook Incorporated recalls Williams Cystoscopic Injection Needles","firm":"Cook Incorporated","date":"2026-09-16","reported":"2026-10-21","status":"Ongoing","classification":"Class II","products":[{"name":"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","code":"UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X","quantity":"97 units","number":"Z-0163-2027","classification":"Class II"}],"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).","affected":"US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.","nationwide":false,"states":["FL","IL","NM","TX","WA"],"units":"97 units","remedy":"","whatToDo":"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.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99875","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0a31cf06ed420ed5","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99875","record":[{"status":"Ongoing","city":"Bloomington","state":"IN","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99875","recalling_firm":"Cook Incorporated","address_1":"750 N Daniels Way","address_2":"","postal_code":"47404-9120","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.","recall_number":"Z-0163-2027","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","product_quantity":"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.","recall_initiation_date":"20260916","center_classification_date":"20261015","report_date":"20261021","code_info":"UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X","more_code_info":""}]}}