Olympus Resection Sheath Recall - Ceramic Tip Breaking
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
- Cease distribution of affected Olympus Resection Sheath (Model No. A22043T)
- Follow manufacturer's recall instructions
- 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
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