Olympus Corporation of the Americas recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11
Olympus Corporation of the Americas is recalling Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 – 305 units. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 19, 2026. Distributed International distribution in the country of Japan..
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 |
| Brand | Olympus Corporation of the Americas |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 19, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 305 units |
| Recall ID | 99627 |
Recalled products
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- FDA recall number
- Z-3216-2026
- Codes, lots and dates
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Quantity
- 305 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99627
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Center Valley, PA, United States
Why it was recalled
The reason the FDA lists: “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,”
Where it was sold
Distribution as the FDA records it: “International distribution in the country of Japan.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99627, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Olympus Corporation of the Americas recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Olympus Corporation of the Americas recall: Olympus Tripp-Lite P580-025 25ft DisplayPort CableMedical devices · 543 cables | While in the high-power operating mode, a video dropout/blackout may occur when using a pa… Serious | FDA Class II |
| Oct 7, 2026 | Olympus Corporation of the Americas recall: Olympus M3 Gold Autoclavable Foroblique Telescope 30 and 1 more productMedical devices · 72 units; 50 units | There are identified discrepancies between the sterilization parameters listed in the Inst… Serious | FDA Class II |
| Sep 30, 2026 | Olympus Corporation of the Americas recall: Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector and 3 more productsMedical devices · 404 units; 105 units; 2,142 units; 816 units | Potential for detachment of ceramic tip due to manufacturing without the designated amount… Serious | FDA Class II |
| Sep 2, 2026 | Olympus Corporation of the Americas recall: Powerseal 5 MMMedical devices · 335 units | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-c… Serious | FDA Class II |
All 5 Olympus Corporation of the Americas recalls →
About this recall
Is Olympus Corporation of the Americas Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11 recalled?
Yes. Olympus Corporation of the Americas recalled it on August 19, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
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,
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
International distribution in the country of Japan..
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.