Z-1437-2026Class II

Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A

Name: Z-1437-2026 Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A
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

FDA source

Olympus Corporation of the Americas began a recall of Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A on 2024-09-13. FDA classified it as Class II and gives the reason as "Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1437-2026
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-13
Posted: 2026-02-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product code: GCP Endoscope, Ac-Powered And Accessories
Reason for recall: Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
FDA root cause: Under Investigation by firm
Action: On January 15, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected products in your inventory. 3. Olympus requests that you acknowledge receipt of this letter through the recall web portal provided. 4. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your WA22810A outer sheath. 5. If you have further distributed this product, please forward this notification to other users.
Quantity in commerce: 633 units
Distribution: Distribution US nationwide.
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-1437-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1437-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20

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)