The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0943-2024·Announced 2024-02-07

Olympus EZDilate Balloon Dilators Recalled for Device Malfunction and Retained Foreign Bodies

Olympus recalled EZDilate Wire Guided Balloon endoscopic dilators due to reports of bursting, leaking, and retained foreign bodies during patient procedures. The Class II recall affects 4,182 units used to treat esophageal strictures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for an endoscopic device with reported malfunction incidents including bursting, leaking, and retained foreign bodies in patients. While no hospitalizations or serious injuries are explicitly reported in the source, the documented adverse events during invasive medical procedures indicate significant risk of patient harm.

Plain-English summary

Olympus Corporation of the Americas is recalling the EZDilate Wire Guided Balloon, Model BD-410X-1855, an endoscopic medical device used to dilate strictures in the alimentary tract in adults and adolescents over 12 years old. Approximately 4,182 units have been distributed nationwide and to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.

The recall was issued after reports of device malfunction including failures during inflation and deflation, inability to properly retrieve the device, bursting, and leaking. In addition, there have been reports of foreign bodies retained in patients and prolonged procedures during use.

Healthcare providers and facilities should identify affected units using the lot numbers provided (360769, 360770, 368258, 368259, 368844, 369417, 385724, 387425, 387426, 387794, 387795) and discontinue use immediately. Patients who have received this device should contact their healthcare provider to discuss any concerns.

For complete information, contact Olympus Corporation of the Americas or consult the FDA recall database.

The recalled product

Product
EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years). Model: BD-410X-1855
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopic / Alimentary Tract
Hazard
Affected units
4,182

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

  • UDI-DI: 00821925033269 Lot Numbers: 360769
  • 360770
  • 368258
  • 368259
  • 368844
  • 369417
  • 385724
  • 387425
  • 387426
  • 387794
  • 387795

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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