FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- Recall number
- Z-3216-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
- Status
- Open, Classified
- Initiated
- 2026-08-19
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- 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,
- Root cause
- Process control
- Action
- Olympus notified their direct customer on about 08/19/2026 via emailed "URGENT: MEDICAL DEVICE RECALL/PRODUCT REMOVAL" letter. The consignee was instructed to examine inventory for affected units, acknowledge receipt of the recall notification by completing and returning the Reply Form, arrange for the return of affected units for replacement, and if affected units have been further distributed, notify those customers.
- Quantity
- 305 units
- Distribution
- International distribution in the country of Japan.
- Lot, serial or model codes
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28