Olympus Recalls Resection Inner Sheaths Due to Ceramic Tip Breakage

Source: FDA · United States

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Olympus Corporation of the Americas is recalling over 7,400 resection inner sheaths used in urologic procedures due to reports of the ceramic tip breaking.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on March 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Resection Inner Sheaths following reports of the ceramic tip breaking. This Class II recall was officially classified by the FDA on February 20, 2026, after the firm received complaints regarding the device's structural integrity during use.

Which Products Are Affected

The recall involves the following medical device used in urologic applications:

  • Product Name: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath
  • Model Number: A22040T
  • UDI: 04042761029360
  • Lots: All lots are affected
  • Quantity: 7,426 units
  • Distribution: Nationwide across the United States

What You Should Do

The firm began notifying customers of the issue via a notification letter on November 11, 2025. Healthcare facilities and providers currently using these devices should follow the specific instructions provided in the firm's letter. For further information or questions regarding the recall, the recalling firm is Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

The breakage of a ceramic tip during a urologic procedure poses a potential risk of injury to the patient or may require additional medical intervention to address the broken fragments.

Source

Information provided by the FDA under recall number Z-1440-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Olympus Corporation of the Americas is recalling over 7,400 resection inner sheaths used in urologic procedures due to reports of the ceramic tip breaking.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.