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

Olympus Resection Inner Sheath recalled by Olympus Corporation of the

Olympus Corporation of the Americas is recalling Olympus Resection Inner Sheath for, 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. A22040T; UDI: 04042761029360; All Lots.

Quantity recalled7,426 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-1440-2026
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 Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Where it was distributed

US Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Model No. A22040T; UDI: 04042761029360; 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 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

19 other products · FDA event 98288

This product is part of a recall event; the main page for the event is Olympus Sheath recalled by Olympus Corporation of the.

Reported	Class	Recall	Company	Reason	Where
4 Mar 2026	CLASS II	Olympus Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath., with Deflecting Obturator recalled	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath, Long recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Resection Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide
4 Mar 2026	CLASS II	Olympus Inner Sheath, Long recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Device Malfunction	Nationwide

More recalls from Olympus Corporation of the Americas

All 415

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2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide