Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog
FDA device recall Z-0482-2026 · posted 2025-11-07 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Action taken
- 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 the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail Cynthia.Ow@Olympus.com.
- Root cause
- Packaging
- Status
- Open, Classified
- Product code
- FDI
- Quantity affected
- 48208 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of GU, and MP.
- Date initiated
- 2025-10-06
- Date posted
- 2025-11-07
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Single Use Electrosurgical Snare SD-400 (K172734) | Olympus Medical Systems Corp. | 2017-12-07 |