Pentax Video Cystoscope ECY-1570 Models: Missing FDA Clearance
Pentax recalls video cystoscope models ECY-1570 and ECY-1570K due to lack of FDA 510(k) premarket clearance. Affected units have specific serial numbers listed in the recall notice.
Recall notice
The video cytoscopes lack 510(k) premarket notification clearance.
Contact the company
What happened, in plain English
Pentax is recalling two video cystoscope models (ECY-1570 and ECY-1570K) because they were not cleared by the FDA before being sold. This means the devices may not be safe for medical use without proper regulatory approval. Read more at govinfonow.com/recall/73426-pentax-video-cystoscope-ecy-1570-models-missing-fda-clearance.
Source Summary by GovInfoNow · govinfonow.com/recall/73426-pentax-video-cystoscope-ecy-1570-models-missing-fda-clearance · Updated September 20, 2026 · FDA enforcement record: FDA #Z-0615-2018
Cite this page
“Pentax Video Cystoscope ECY-1570 Models: Missing FDA Clearance.” GovInfoNow, updated September 20, 2026. https://govinfonow.com/recall/73426-pentax-video-cystoscope-ecy-1570-models-missing-fda-clearance. Based on FDA recall #Z-0615-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2018%22&limit=1).
Why it’s dangerous
The video cystoscopes lack FDA 510(k) premarket clearance, which is required for medical devices to ensure they are safe and effective before being sold. Without this clearance, the devices may not meet safety standards, potentially leading to medical risks.
Who’s affected
Medical professionals who own or use these specific video cystoscope models are affected. Patients using these devices could be at risk if the equipment is not properly cleared by the FDA.
How to tell if you have this one
Check for the model numbers ECY-1570 or ECY-1570K on the device. Affected units have specific serial numbers listed in the recall notice, including J110097 through J110078 and others.
- Brand
Pentax- Category
Medical device
What to do — step by step
Check Device Model
Look for the model numbers ECY-1570 or ECY-1570K on the video cystoscope.
Where it went and when
Where it was distributed
Distributed in 8 states.
FDA distribution: “Distributed in 8 states: CA, IL, MD, MI, ND, NH, NY, SD, and Guam.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Maryland, Michigan, New Hampshire, New York, North Dakota, South Dakota.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0615-2018 (July 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0615-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.