Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Sin
Pending LLM rewrite. Source: FDA_DEVICE Z-0483-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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