Olympus Device Recall - 26 Fr Sheath Ceramic Tip
Summary
The FDA has issued a Class II device recall for Olympus Resection Inner Sheaths (Model No. A22040A) due to complaints of the ceramic tip breaking. The recall affects nationwide distribution within the US and is ongoing.
What changed
The FDA has initiated a Class II device recall for Olympus Corporation of the Americas' Resection Inner Sheath, Model No. A22040A, used for urologic applications with a 26 Fr. outer sheath. The recall is due to reports of the ceramic tip breaking off during use, posing a potential risk to patients. This is an ongoing recall with nationwide distribution in the US.
Healthcare providers and medical device distributors who have received these products should review their inventory and follow Olympus's specific recall procedures. Compliance with recall instructions is mandatory to ensure patient safety and adherence to FDA regulations. Failure to comply with recall procedures can result in further regulatory action.
What to do next
- Review inventory for affected Olympus Resection Inner Sheath, Model No. A22040A.
- Follow Olympus's specific recall procedures for affected devices.
- Ensure patient safety by removing or addressing affected devices as per recall instructions.
Source document (simplified)
Olympus Corporation of the Americas
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1439-2026 · 20260304 · Ongoing
Product
Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. 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
Related changes
Source
Classification
Who this affects
Taxonomy
Browse Categories
Get Healthcare alerts
Weekly digest. AI-summarized, no noise.
Free. Unsubscribe anytime.
Get alerts for this source
We'll email you when FDA: Device Recalls Class II publishes new changes.