Lower risk Medical device recall · FDA · Published October 6, 2025

Olympus SD-400 Electrosurgical Snare: Sterility Risk in Packaging

Olympus recalls SD-400 electrosurgical snare devices due to potential sterility compromise from small holes in packaging during shipping. Affected units include specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0483-2026Medical device Olympus ›

Lower-risk 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.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling single-use electrosurgical snare devices because small holes in the packaging may compromise sterility. This could lead to infections if the device is used without proper sterilization. Read more at govinfonow.com/recall/51107-olympus-sd-400-electrosurgical-snare-sterility-risk-in-packaging.

Source Summary by GovInfoNow · govinfonow.com/recall/51107-olympus-sd-400-electrosurgical-snare-sterility-risk-in-packaging · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0483-2026

Cite this page

“Olympus SD-400 Electrosurgical Snare: Sterility Risk in Packaging.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51107-olympus-sd-400-electrosurgical-snare-sterility-risk-in-packaging. Based on FDA recall #Z-0483-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0483-2026%22&limit=1).

The FDA announced on Oct. 6, 2025, that Olympus Corporation of the Americas is recalling Single Use Electrosurgical Snare SD-400 devices due to compromised sterility. The agency issued recall number Z-0483-2026 for the voluntary Class II action affecting worldwide distribution.

How to tell if you have it

Brand: Olympus
Product Name: Single Use Single Use Electrosurgical Snare
Model/Catalog Number: SD-U400U-15, 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
Units affected: 18,174

The hazard

The sterility of the device pouches may be compromised from small holes that occur during packaging into the shelf carton and/or during transportation. The FDA stated this hazard in its official recall record.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Other recent recalls by the brand include the Olympus Tripp-Lite P580-025 DisplayPort Cable (2026-08-27), the Olympus M3 Gold Autoclavable Lateral Telescope (2026-08-24), and the Olympus BiCOAG Hemostasis Probe (2026-08-19). Other recent recalls of similar products include Medline Convenience Kits Recall (2026-01-07), Arrow Pacing PSI Kit Recall (2026-04-21), and Depuy ATTUNE Revision Hinge Femoral RT SZ 7 CEM (2026-04-03).

How to tell if you have this one

Check for lot numbers 27V through 56V on the packaging. The product model is SD-400U-15 with a unique device identifier (UDI) starting with 04953170408250.

Brand
Olympus
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of GU, and MP.

Recall number	Product, codes & lots	Quantity
Z-0482-2026	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.; 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, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V UDI: 04953170408243	48208 units
Z-0483-2026	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.; 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	18174 units

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers 27V through 56V on the packaging to identify affected units.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of GU, and MP.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Oct 6, 2025Firm started the recall
Nov 7, 2025FDA classified it Class II
Nov 19, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51107-olympus-sd-400-electrosurgical-snare-sterility-risk-in-packaging">Olympus SD-400 Electrosurgical Snare: Sterility Risk in Packaging (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0483-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0483-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.