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

Timeline

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

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 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.

ReportedClassRecallCompanyReasonWhere
CLASS IIOlympus Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath., with Deflecting Obturator recalledOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath, Long recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Resection Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide
CLASS IIOlympus Inner Sheath, Long recalled by Olympus Corporation of theOlympus Corporation of the AmericasDevice MalfunctionNationwide

More recalls from Olympus Corporation of the Americas

All 420
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Fixed Pin Connector recalledOlympus Corporation of the AmericasOtherNationwide
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Coaxial Connector recalledOlympus Corporation of the AmericasOtherNationwide
DeviceCLASS IIOlympus EZDilate Endoscopic Balloon Dilator Wired-guided recalledOlympus Corporation of the AmericasOtherPA
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Coaxial Connector recalledOlympus Corporation of the AmericasOtherNationwide
DeviceCLASS IIOlympus BiCOAG Hemostasis Probe Fixed Pin Connector recalledOlympus Corporation of the AmericasOtherNationwide

Other Other Medical Devices recalls

All 13,857
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIMedline Convenience Kits: Major Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
DeviceCLASS IIMedline Convenience Kits: Peds Sinus Pack recalled by Medline IndustriesMedline IndustriesOtherNationwide
DeviceCLASS IISmartPath to dStream for XR and 3.0T recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIAchieva 1.5T, Achieva 1.5T Conversion recalled by Philips North AmericaPhilips North AmericaDevice MalfunctionNationwide
DeviceCLASS IIMedline Convenience Kits: Mfc Craniotomy Pack recalledMedline IndustriesOtherNationwide