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 16-17-18, 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
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-0937-2024
- 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 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1880
Where it was distributed
Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
Questions about this recall
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: 00821925033191 Lot Numbers: 365375, 365823, 365824, 365825, 369028, 382273, 382350, 382351, 383160 Added 12/1/23: 376575, 376888,376914
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 93508This product is part of a recall event; the main page for the event is EZDilate Wire Guided Balloon recalled by Olympus Corporation of the.
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|---|---|---|---|---|---|
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