Agency classClass IIOur severity:High FDA (Devices)·Z-0934-2024·Announced 2024-02-07

Olympus EZDilate Balloons Recalled for Bursting, Leaking, and Retrieval Failure

Olympus is recalling EZDilate Fixed Wire Balloons used for esophageal dilation due to reports of bursting, leaking, and difficulty retrieving the device. The recall affects 1,796 units distributed nationwide and internationally.

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 medical device recall for endoscopic equipment with reported malfunctions (bursting, leaking, foreign body events) but no reported hospitalizations or injuries documented in the source text. Falls under risk-of-harm category where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling EZDilate Fixed Wire Balloons (Model BD-400P-1080), which are used for endoscopic dilation of esophageal strictures in patients 12 years and older. The recall was issued due to reports of device malfunction during use, specifically issues with inflation, deflation, and device retrieval.

The reported problems include bursting, leaking, and events involving foreign bodies in patients, as well as prolonged procedure times. These malfunctions could complicate patient care during and after the endoscopic procedure.

A total of 1,796 units have been recalled. The affected lot numbers are 366479, 384325, and 384502. The devices were distributed nationwide and internationally to Australia, Brazil, Canada, Germany, Hong Kong, India, Japan, and Singapore.

Healthcare providers should cease use of these devices and contact Olympus for replacement instructions. Patients who have undergone esophageal dilation procedures using these balloons should consult their healthcare provider with any concerns.

The recalled product

Product: EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1080
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device
Hazard: device-burst
device-leak
foreign-body
retrieval-failure
Affected units: 1,796

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 (3)

UDI-DI: 00821925033177 Lot Numbers: 366479
384325
384502

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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