CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled
Olympus Corporation of the Americas is recalling Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12. The recall was initiated on 19 Aug 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-3216-2026
- FDA event ID
- 99627
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Aug 2026
- FDA classified
- 18 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 19 Aug 2026 | Recall initiated by company | |
| 18 Sep 2026 | Classified by FDA | +30 days |
| 30 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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,
Product as listed by the FDA
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Where it was distributed
International distribution in the country of Japan.
Questions about this recall
Why was it recalled?
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,
Which lots are affected?
Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
Where was it sold?
International distribution in the country of Japan.
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 6 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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