Z-0364-2025Class II

Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number...

Name: Z-0364-2025 Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number...
Creator: Olympus Corporation of the Americas
Published: 2024-09-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-09-11 / Open, Classified / root cause: packaging

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX... on 2024-09-11. FDA classified it as Class II and gives the reason as "Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0364-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-11
Posted: 2024-11-12
Recalling firm: OLYMPUS Corporation of the Americas
Product: Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Model/Catalog Number: 61024BX, 61038BX, 61046BX, 61054BX, 61124BX, 61138BX, 61146BX, 61154BX, 61224BX, 61238BX, 61246BX, 61254BX, 61324BX, 61338BX, 61346BX, 61354BX Software Version: N/A Product Description: The Olympus UroPass Ureteral Access Sheath Set consists of a hydrophilic coated outer sheath and an inner tapered dilator intended to establish a conduit for the passage of endoscopes and retrieval devices into the ureter. The hydrophilic coating on the UroPass Ureteral Access Sheath eases passage and placement. Both the outer sheath and inner dilator are radio-opaque for ease of viewing radiographically. Intended for single use only. Component: N/A
Product code: KNY Accessories, Catheter, G-U
Reason for recall: Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
Root cause tag: packaging
FDA root cause: Storage
Action: ****UPDATE Nov 8, 2024*** Olympus mailed a revision letter-URGENT: MEDICAL DEVICE CORRECTION UPDATED INFORMATION to consignees on November 8, 2024. Letter states; To reduce the risk of UV exposure to your device(s), Olympus instructs users to implement the following actions: Minimize the exposure of UroPass Ureteral Access Sheaths to ultraviolet light. Exposure to UV light during storage periods may cause embrittlement of this device, increasing the potential for breakage and patient injury, including retained device fragments, tissue damage, or perforation of the ureter. Updated Information: " As instructed in IFU Section 4.0, inspect the device prior to use. If any damage to the device is noted, DO NOT USE. " Inspect the device upon removal or completion of the procedure. If damage is noted, the patient should be evaluated for a potentially retained foreign body. " Sharp edges of a broken sheath have been reported to have caused ureteral tissue damage or perforation. If device damage is noted, patients should be monitored intraoperatively and in the immediate post-operative period for these types of injuries. Olympus is not requiring the return of your UroPass device(s) as a result of this action. However, if you want to return the UroPass device(s) in your inventory, please contact Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of your affected product. 4. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new information regarding UV exposure. Olympus is in the process of updating the Instructions for Use with this information. 5. Olympus requests that you acknowledge receipt of this letter. Access the Olympus recall portal to indicate that you have received this notification. a. Go to https://olympusamerica.com/recall b. Enter the recall number "0458 c. Complete the form as instructed. 6. If
Quantity in commerce: 14,093 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, China, Germany, Hong Kong, Japan, Republic of South Korea, Singapore.
Product codes and lots: Model/UDI-DI: 61024BX/00821925035317, 61038BX/00821925035324, 61046BX/00821925035331, 61054BX/00821925035348, 61124BX/00821925035355, 61138BX/00821925035362, 61146BX/00821925035379, 61154BX/00821925035386, 61224BX/00821925035393, 61238BX/00821925035409, 61246BX/00821925035416, 61254BX/00821925035423, 61324BX/00821925035430, 61338BX/00821925035447, 61346BX/00821925035454, 61354BX/00821925035461.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0364-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0364-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-20	2024-11-12

Product code KNY

K051593Class IIUropass Ureteral Access Sheath, Model 61224Acmi Corporation / cleared 2005-09-02

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)