Skip to content

Brand Name: Olympus recallZ-0351-2025 · Olympus Corporation of the Americas · initiated Sep 13, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On October 11, 2024 URGENT: MEDICAL DEVICE CORRECTION letters were sent to consignees. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above-listed device. 3. You should not use the Cystoscope Outer sheath, 22.5 French with a GreenLight Laser for BPH therapy until further notice from Olympus. Add a copy of this letter to any on-hand copies of the Instructions for Use. 4. Olympus requests that you acknowledge receipt of this letter. Acknowledge receipt of this letter through the Olympus web portal: a. Go to https://olympusamerica.com/recall b. Enter the recall number "0460 c. Complete the form as instructed. 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including the device breaking off into the patient, or any associated injuries to the Technical Assistance Center (TAC) at 1- 800-848-9024 (option 1), and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 from Monday through Friday, 9 am to 5 pm EDT, or by e-mail at [email protected].

Recall details

Recall number
Z-0351-2025
Status
Open, Classified
Initiated by the company
Sep 13, 2024
Posted by the FDA
Nov 8, 2024
Recalling firm
Olympus Corporation of the Americas
Quantity
738 units
Product code
GCP
FDA submissions
K790071
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.

Product 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

Code information (models, lots, serial numbers)

Model: WA2280A, UDI: 04042761051729, Lot#: All lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page