Olympus Corporation Recalls Cystoscope Outer Sheaths Due to Laser Incompatibility
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 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.
Source: FDA Official Notice