Olympus Corporation of the Americas Recall 95584
Description: Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A
Olympus Corporation of the Americas Recall 95584 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0351-2025 |
| Event ID | 95584 |
| Event Description | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. |
| Quantity | 738 units |
| Recall Reason | Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe. |
| Device Classification | 20241120 |
| Device Code Info | Model: WA2280A, UDI: 04042761051729, Lot#: All lots. |
| Center Classification Date | 20241108 |
| Recall Initiation Date | 20240913 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
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