Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product… — Class II medical device recall Z-0482-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2025-11-19, distributed nationwide. Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf ca
| Recall number | Z-0482-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2025-10-06 |
| Classified | 2025-11-07 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 48,208 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04953170408243 |
| 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, 51V, 52V, 53V, 54V, 55V, 56V, 57V |
| Model numbers | SD-400U-10 |
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 diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0482-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.