EZDilate Fixed Wire Balloon 6-7-8. Indicated for recall: Foreign Material
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model…
Why was EZDilate Fixed Wire Balloon 6-7-8. Indicated for 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00821925033160 Lot Number: 380777
- Product
- EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 126 units
- Distribution
- Nationwide. Foreign: AU BR BR CA DE HK IN JP SG
- Recall date
- February 7, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)