Brand Name: Olympus Single Use Single Use recall: Sterility Concern
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number…
Why was Brand Name: Olympus Single Use Single Use recalled?
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
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?
Model: SD-400U-15; Lot Numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 4ZV, 51V, 52V, 53V, 54V, 55V, 56V UDI: 04953170408250
- Product
- Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 18174 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of GU, and MP.
- Recall date
- November 19, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)