Olympus Recalls Resection Sheaths Due to Risk of Ceramic Tip Breakage

Source: FDA · United States

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Olympus Corporation of the Americas has issued a voluntary recall for 207 Resection Sheaths (Model A22043T) following reports of the ceramic tip breaking during urologic procedures.

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 Sheath, 28 Fr. with Deflecting Obturator. The recall was prompted by multiple complaints regarding the ceramic tip of the resection sheath breaking during use. This device is specifically designed for urologic applications.

Which Products Are Affected

The recall affects the following medical device:

  • Product Name: Olympus Resection Sheath, 28 Fr. with Deflecting Obturator
  • Model Number: A22043T
  • UDI: 04042761021012
  • Lot Information: All Lots are included in this recall
  • Quantity: 207 units
  • Recall Number: Z-1446-2026

The products were distributed nationwide across the United States.

What You Should Do

Olympus Corporation of the Americas began notifying affected customers via a formal letter on November 11, 2025. Healthcare facilities and providers currently in possession of these devices should refer to the instructions provided in the firm's notification letter regarding the management or return of the affected units. For further information, providers may contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.

Why This Matters

The breakage of a ceramic tip during a urologic procedure poses a risk of injury to the patient, including the potential for fragments to remain within the body or cause internal damage. The FDA has classified this as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.

Source

This information is based on official recall data provided by the FDA.

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 issued a voluntary recall for 207 Resection Sheaths (Model A22043T) following reports of the ceramic tip breaking during urologic procedures.
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.