The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0936-2024·Announced 2024-02-07

EZDilate Endoscopic Balloon Devices Recalled for Malfunction and Foreign Body Risk

Olympus is recalling EZDilate Fixed Wire Balloon devices used for esophageal stricture treatment due to reports of inflation/deflation failures, bursting, leaking, and foreign body retention in patients.

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: FDA Class II classification combined with documented reports of device malfunction during clinical use, including bursting, leakage, and foreign body retention events in patients. These represent risk-of-harm adverse events without explicit injury or hospitalization reporting in the source text.

Plain-English summary

Olympus Corporation of the Americas is recalling EZDilate Fixed Wire Balloon devices (Model BD-400P-1580) in sizes 13.5, 14.5, and 15.5mm. These devices are used during endoscopic procedures to dilate strictures of the esophagus in patients aged 12 and older. The company identified issues with device inflation, deflation, and retrieval, including reports of bursting and leaking. Additionally, reports document events involving foreign body retention in patients and prolonged procedures.

The recall affects 5,232 units distributed nationwide and internationally (Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore). The affected lot numbers are: 360910, 360911, 364014, 364158, 364338, 367646, 367647, 367648, 383363, 383846, 383847, and 384058.

Healthcare providers and patients who have received treatment with these devices should contact their healthcare provider immediately if they experience symptoms or concerns related to the procedure. Facilities should quarantine unused devices from the affected lot numbers and return them according to Olympus Corporation instructions.

The recalled product

Product
EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1580
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Endoscopic / Surgical
Hazard
Affected units
5,232

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 (12)

  • UDI-DI: 00821925033191 Lot Numbers: 360910
  • 360911
  • 364014
  • 364158
  • 364338
  • 367646
  • 367647
  • 367648
  • 383363
  • 383846
  • 383847
  • 384058

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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