Changeflow GovPing Healthcare Olympus Resection Sheath Recall - Ceramic Tip B...
Urgent Enforcement Removed Final

Olympus Resection Sheath Recall - Ceramic Tip Breaking

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 4th, 2026
Detected March 29th, 2026
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Summary

The FDA has initiated a Class II recall for Olympus Resection Sheath (Model No. A22043T) due to complaints of the ceramic tip breaking during urologic applications. The recall affects nationwide distribution within the US.

What changed

The FDA has classified a recall of the Olympus Resection Sheath (Model No. A22043T) as Class II, indicating a potential health hazard. The issue stems from reports of the ceramic tip breaking during use in urologic procedures. This recall impacts distribution across the United States.

Healthcare providers and medical device distributors in possession of the affected product should cease distribution and follow the manufacturer's instructions for recall. While not explicitly stated, non-compliance with recall procedures can lead to regulatory action by the FDA. The ongoing nature of the recall suggests that affected parties should be actively managing their inventory and customer notifications.

What to do next

  1. Cease distribution of affected Olympus Resection Sheath (Model No. A22043T)
  2. Follow manufacturer's recall instructions
  3. Manage inventory and customer notifications

Source document (simplified)

Olympus Corporation of the Americas

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1446-2026 · 20260304 · Ongoing

Product

Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.

Reason for Recall

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

Distribution

US Nationwide Distribution.

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1446-2026

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Recall
Threshold
Class II recall
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Recall Management

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