Recall Z-0482-2026 ยท FDI Snare, Flexible
Olympus Corporation of the Americas
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.
| Date | Nov 7, 2025 (initiated Oct 6, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Packaging |
| Action | On October 6, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Examine your inventory and quarantine any affected devices. Cease usage of the product immediately. Please contact customer service to request a return material authorization, a credit will be issued for any returned product. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints, including holes in device packaging, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and |
| Quantity | 48208 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of GU, and MP. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172734 | Single Use Electrosurgical Snare SD-400 Olympus Medical Systems Corp., Dec 7, 2017 |