[pending] Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgica
Pending LLM rewrite. Source: FDA_DEVICE Z-0482-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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 Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
- 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-10
- 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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