CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report
Williams Cystoscopic Injection Needles, used recalled by Cook
Cook is recalling Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, distributed in Florida, Illinois, New Mexico, Texas, Washington. The recall was initiated on 16 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0163-2027
- FDA event ID
- 99875
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Sep 2026
- FDA classified
- 15 Oct 2026
- Reported
- 21 Oct 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Syringes & Needles
Timeline
| 16 Sep 2026 | Recall initiated by company | |
| 15 Oct 2026 | Classified by FDA | +29 days |
| 21 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI-DI: 00827002161122; Lot Numbers: 16613606, 16951548, 16951548X
Where was it sold?
US States: FL, IL, NM, TX, WA. Canada, France, Germany, Italy, Spain, Switzerland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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