To be used with ultrasound endoscopes for ultrasound recall
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial…
Why was To be used with ultrasound endoscopes for ultrasound recalled?
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
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: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937
- Product
- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1297 (Boxes; 5 per Box)
- Distribution
- Natiowide Foreign: Canada, Germany
- Recall date
- May 31, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)