Cook Incorporated: Endoscopic Injection Needle, Gastroenterology-urology
Recall Summary Cook Incorporated is recalling Williams Cystoscopic Injection Needles (Reference Part Number 090001-S26) used in urological procedures to inject medication into the bladder and urethra. The female Luer lock adapter on these needles may not be properly secured due to manufacturing errors, which could result in increased procedure time or inadequate treatment. The affected devices were distributed to medical facilities in Florida, Illinois, New Mexico, Texas, and Washington, as well as in Canada and several European countries.
- Recalling firm
- Cook Incorporated
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-16
- Status
- Open, Classified
- Areas affected
- FL, IL, NM, TX, WA
- Distribution
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a3c27cb9-1e3f-4ad1-b72d-3d8d64354b9a