Olympus Corporation Recalls Resection Sheaths Due to Risk of Ceramic Tip Breaking

Source: FDA · United States

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Olympus Corporation of the Americas has voluntarily recalled 2,626 resection sheaths used in urologic procedures because the ceramic tips may break during use.

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 sheaths following reports that the ceramic tip of the device can break. The recall was classified by the FDA as a Class II event on February 20, 2026.

Which Products Are Affected

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

  • Product Name: Olympus Resection Sheath, 24 Fr., with Deflecting Obturator
  • Model Number: A22041T
  • UDI: 04042761020978
  • Affected Units: 2,626 units
  • Lot Information: All lots are included in this recall.
  • Recall Number: Z-1442-2026

These products were distributed nationwide throughout the United States.

What You Should Do

Olympus Corporation of the Americas began notifying customers of the issue via a firm-initiated letter on November 11, 2025. Healthcare providers and facilities possessing these devices should follow the instructions outlined in the notification letter regarding the affected units. For further information, providers should contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.

Why This Matters

The breakage of a ceramic tip during a surgical procedure poses a risk of injury to the patient and may necessitate additional medical intervention to retrieve fragments from the body.

Source

Information provided by the FDA. Recall Event ID: 98288.

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 has voluntarily recalled 2,626 resection sheaths used in urologic procedures because the ceramic tips may break during use.
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.