FDAFDA recall Z-0163-2027 · Oct 21, 2026
Cook Incorporated: Williams Cystoscopic Injection Needles recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
- Quantity
- 97 units
- Distribution
- US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
- Recalling firm
- Cook Incorporated, Bloomington, IN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-16
Source: openFDA enforcement record Z-0163-2027 · search recall number Z-0163-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.