CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report

EZDilate Fixed Wire Balloon recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling EZDilate Fixed Wire Balloon 18-19-20, distributed nationwide in the US. The recall was initiated on 10 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00821925033214 Lot Numbers: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893 382697, 382698, 383359, 383360, 383361 Added 12/1/23: 376573, 376574, 376918, 377491

Quantity recalled8294 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0938-2024
FDA event ID: 93508
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Nov 2023
FDA classified: 31 Jan 2024
Reported: 7 Feb 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

10 Nov 2023	Recall initiated by company
31 Jan 2024	Classified by FDA	+82 days
7 Feb 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080

Where it was distributed

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

Nationwide California

Questions about this recall

Is EZDilate Fixed Wire Balloon 18-19-20 recalled?

Yes. Olympus Corporation of the Americas recalled EZDilate Fixed Wire Balloon 18-19-20 on 10 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0938-2024.

Why was it recalled?

Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.

Which lots are affected?

UDI-DI: 00821925033214 Lot Numbers: 364645, 365580, 365582, 365586, 375543, 375973, 381391, 381558, 381559, 381560, 381892, 381893 382697, 382698, 383359, 383360, 383361 Added 12/1/23: 376573, 376574, 376918, 377491

Where was it sold?

Nationwide. Foreign: AU BR BR CA DE HK IN JP SG

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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