Z-0351-2025Class II

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version...

Name: Z-0351-2025 Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version...
Creator: Olympus Corporation of the Americas
Published: 2024-09-13
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-09-13 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be... on 2024-09-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0351-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-13
Posted: 2024-11-08
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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 code: GCP Endoscope, Ac-Powered And Accessories
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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].
Quantity in commerce: 738 units
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 codes and lots: Model: WA2280A, UDI: 04042761051729, Lot#: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0351-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-08

Product code GCP

K790071Class IIEndoscope and AccessoriesOlympus Corp. / cleared 1979-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)