Single Use Electrosurgical Snare SD-400 recallZ-0483-2026 · Olympus Corporation of the Americas · initiated Oct 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0483-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 6, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 18174 units
- Product code
- FDI
- FDA submissions
- K172734
- Distribution
- Worldwide distribution - US Nationwide and the countries of GU, and MP.
Product description
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/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
Code information (models, lots, serial numbers)
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, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 4ZV, 51V, 52V, 53V, 54V, 55V, 56V UDI: 04953170408250
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Single Use Electrosurgical Snare SD-400 SD-400U-15Olympus Medical Systems Corp. · SNARE, NON-ELECTRICAL1 recall7 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97733).
- Z-0482-2026 · Open, ClassifiedBrand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments h…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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