Olympus Corporation Recalls Cystoscope Outer Sheaths Due to Laser Incompatibility

Source: FDA · United States

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Olympus Corporation of the Americas has recalled 633 Cystoscope Outer Sheaths because use with GreenLight Lasers can damage the device tip during BPH therapy.

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 "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 specific Cystoscope Outer Sheaths. The recall was prompted by a discovered incompatibility when the device is used in conjunction with a GreenLight Laser for Benign Prostatic Hyperplasia (BPH) therapy. This incompatibility can lead to damage at the tip of the device during medical procedures.

Which Products Are Affected

The recall involves 633 units distributed nationwide across the United States. The following details identify the affected products:

  • Product Name: Olympus Cystoscope Outer Sheath
  • Model/Catalog Numbers: WA22810A and WA2280A
  • UDI: 04042761051729
  • Lot Information: All lots are included in this recall.

What You Should Do

Healthcare facilities and providers should immediately check their inventory for the affected model numbers. The firm initiated the recall process via a notification letter to customers. For information regarding the return or management of these devices, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

This is a Class II recall, indicating that the use of the affected product may cause temporary or medically reversible adverse health consequences. In this case, the primary risk involves damage to the device tip during surgical laser therapy, which could impact the safety and efficacy of the procedure.

Source

Information provided by the FDA under Recall Number Z-1437-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Olympus Corporation of the Americas has recalled 633 Cystoscope Outer Sheaths because use with GreenLight Lasers can damage the device tip during BPH therapy.
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.