CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

Single Use Electrosurgical Snare recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Single Use Electrosurgical Snare, distributed nationwide in the US. The recall was initiated on 6 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 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

Quantity recalled48208 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0482-2026
FDA event ID: 97733
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Oct 2025
FDA classified: 7 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

6 Oct 2025	Recall initiated by company
7 Nov 2025	Classified by FDA	+32 days
19 Nov 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of GU, and MP.

Nationwide

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the countries of GU, and MP.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97733

This product is part of a recall event; the main page for the event is Single Use Single Use Electrosurgical Snare recalled.

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025	CLASS II	Single Use Single Use Electrosurgical Snare recalled	Olympus Corporation of the Americas	Sterility	Nationwide

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