Olympus Inner Sheath Recall - Ceramic Tip Breaking
Summary
The FDA has issued a Class II recall for Olympus Inner Sheath, Model No. WA22017A, due to complaints of the ceramic tip breaking during use. This recall impacts distribution nationwide in the US and is ongoing.
What changed
The FDA has initiated a Class II device recall for the Olympus Inner Sheath, Model No. WA22017A, used in urological and gynecological applications. The recall is prompted by reports of the ceramic tip breaking during procedures, posing a potential risk to patients. The affected product was distributed nationwide in the US.
Medical device manufacturers and healthcare providers should review their inventory and procedures related to this product. While the document indicates the recall is 'ongoing,' specific actions for entities are not detailed beyond the notification of the recall itself. Compliance officers should monitor further communications from Olympus and the FDA regarding corrective actions and potential patient notification requirements.
What to do next
- Review inventory of Olympus Inner Sheath, Model No. WA22017A.
- Monitor communications from Olympus Corporation of the Americas and the FDA regarding recall procedures and corrective actions.
Source document (simplified)
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1450-2026 · 20260304 · Ongoing
Product
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological 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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