Olympus Corporation of the Americas recalls Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Olympus recalls EZDilate Endoscopic Balloon Dilators with model BD-420X-1355 due to potential incorrect inflation chart labels that could lead to improper balloon sizing.
Lower-risk recall
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
What happened, in plain English
Olympus is recalling specific endoscopic balloon dilators that may have incorrect inflation chart labels. This could lead to using a balloon that's too large than intended, potentially causing injury during medical procedures. Read more at govinfonow.com/recall/1292586-olympus-ezdilate-balloon-dilator-recall-incorrect-inflation-chart-label-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/1292586-olympus-ezdilate-balloon-dilator-recall-incorrect-inflation-chart-label-risk · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3216-2026
Cite this page
“Olympus EZDilate Balloon Dilator Recall: Incorrect Inflation Chart Label Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292586-olympus-ezdilate-balloon-dilator-recall-incorrect-inflation-chart-label-risk. Based on FDA recall #Z-3216-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3216-2026%22&limit=1).
Why it’s dangerous
The inflation chart label on the device shaft might incorrectly state a balloon diameter of 18, 19, or 20 mm instead of the actual 11, 12, or 13 mm. This could result in using a balloon that's too large for the intended medical procedure, potentially causing tissue damage or injury.
Who’s affected
Medical professionals using Olympus EZDilate Endoscopic Balloon Dilators with model number BD-420X-1355 are most at risk. Patients undergoing procedures with these devices may also be affected if the incorrect label leads to improper use.
How to tell if you have this one
Check for the model number BD-420X-1355 on the device. The product was sold with lot number 460898 and UDI-DI code 00821925042261.
- Brand
Olympus- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number on the device is BD-420X-1355.
Questions people ask
Why is this product being recalled?
The inflation chart label on the device shaft may be incorrect, indicating a balloon diameter of 18, 19, or 20 mm instead of the actual 11, 12, or 13 mm.
How can I tell if I have the recalled product?
Look for the model number BD-420X-1355 on the device, which was sold with lot number 460898 and UDI-DI code 00821925042261.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact Olympus Corporation of the Americas for further instructions.
Contact Olympus
We’ve drafted a message you can send Olympus to request your refund or repair — edit it as you like.
Subject: Recall Z-3216-2026 — Olympus Olympus Hello, I own a Olympus that is covered by recall Z-3216-2026 from Olympus. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-3216-2026 (August 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3216-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.