medical MODERATE Updated 2026-10-21

Cook Incorporated recalls Williams Cystoscopic Injection Needles, used for cystoscopic

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Recalled 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

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Hazard / Issue

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.

Issued by

FDA

Affected States: FL, IL, NM, TX, WA
Lot/Code Info: UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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