Olympus Recalls Resection Sheaths Over Risk of Ceramic Tip Breakage

Source: FDA · United States

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Olympus Corporation of the Americas has issued a voluntary recall for 899 units of its 8 mm Resection Sheaths due to reports of ceramic tips breaking during gynecological 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, firm-initiated recall of its 8 mm Resection Sheaths. The recall was prompted by complaints regarding the ceramic tip of the resection sheath breaking during use. This device is specifically designed for gynecological applications.

Which Products Are Affected

The recall involves the following medical device:

  • Product Name: Olympus Resection Sheath, 8 mm
  • Model Number: A42011A
  • UDI: 04042761023658
  • Affected Lots: All lots are included in this recall.
  • Quantity: 899 units
  • Distribution: The product was distributed nationwide across the United States.

What You Should Do

Olympus notified affected customers via a formal letter starting in November 2025. Healthcare facilities and providers in possession of these devices should follow the instructions provided in the firm's notification. For additional information or questions regarding returns, consumers may contact Olympus Corporation of the Americas at their headquarters located at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

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

Source

Information provided by the FDA under Recall Number Z-1448-2026.

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 has issued a voluntary recall for 899 units of its 8 mm Resection Sheaths due to reports of ceramic tips breaking during gynecological 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.