Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Published September 30, 2026 · Recall initiated: August 19, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- International distribution in the country of Japan.
- Lot
- Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Related recalls
- FDAOlympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory used in conjunction w…October 7, 2026
- FDAOlympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.October 7, 2026
- FDAOlympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.October 7, 2026
- FDAOlympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.September 30, 2026
- FDABrand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S36…September 30, 2026
- FDAMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse …September 30, 2026
- FDAImager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/…September 30, 2026
- FDAMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse …September 30, 2026
Questions about this recall
Was Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355. recalled?
Yes. FDA published recall Z-3216-2026 on September 30, 2026. Reported hazard: 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 this product?
Voluntary: Firm initiated · E-Mail
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.
Recalert also tracks expiration dates so you can sell stock before it becomes a loss.