CLASS II ONGOING Device recall · Reported 4 Mar 2026 · FDA Enforcement Report

Olympus Resection Sheath recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Resection Sheath, distributed nationwide in the US. The recall was initiated on 11 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel No. A2666; UDI: 04042761004244; All Lots

Quantity recalled1 unit

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-1452-2026
FDA event ID: 98288
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 11 Nov 2025
FDA classified: 20 Feb 2026
Reported: 4 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

11 Nov 2025	Recall initiated by company
20 Feb 2026	Classified by FDA	+101 days
4 Mar 2026	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

Complaints of the ceramic tip of the resection sheath breaking have been received.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Is Olympus Resection Sheath recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Resection Sheath on 11 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-1452-2026.

Why was it recalled?

Complaints of the ceramic tip of the resection sheath breaking have been received.

Which lots are affected?

Model No. A2666; UDI: 04042761004244; All Lots

Where was it sold?

US Nationwide Distribution.

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

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