Olympus Recalls Inner Sheath Model A2642 Over Reports of Breaking Ceramic Tips

Source: FDA · United States

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Olympus Corporation of the Americas is recalling its Inner Sheath Model A2642 after reports that the device's ceramic tip can break during urological procedures.

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

This notice was issued by FDA on March 11, 2026 and geographically references United States. Its severity classification of "high" 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 Class II recall of the Olympus Inner Sheath, Model No. A2642. The recall was issued following reports and complaints that the ceramic tip of the resection sheath can break during use.

Which Products Are Affected

The recall includes all lots of the following product:

  • Product Name: Olympus Inner Sheath
  • Model Number: A2642
  • UDI: 04042761004084
  • Distribution: Nationwide across the United States.

What You Should Do

Olympus has notified affected customers via letter. Healthcare facilities and providers should immediately check their inventory for Model A2642 and follow the instructions provided in the firm's notification. For further assistance or questions regarding the return process, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

The breakage of a ceramic tip during a urological procedure poses a significant risk of injury to the patient, including the potential for foreign material to remain in the body or the need for additional surgical intervention to retrieve the broken fragments.

Source

This information is based on official recall data from the FDA. Recall Number: Z-1456-2026.

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 its Inner Sheath Model A2642 after reports that the device's ceramic tip can break during urological 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 "high" severity. Take precautions and monitor for updates.
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.