Z-3216-2026Class II

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355

Name: Z-3216-2026 Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355
Creator: Olympus Corporation of the Americas
Published: 2026-08-19
License: https://open.fda.gov/license/

Olympus Corporation of the Americas / initiated 2026-08-19 / Open, Classified

FDA source

Recall record

Recall number: Z-3216-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-19
Posted: 2026-09-18
Recalling firm: Olympus Corporation of the Americas
Product: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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,
FDA 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 in commerce: 305 units
Distribution: International distribution in the country of Japan.
Product codes and lots: Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3216-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3216-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code FGE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)