Z-0103-2027

UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10

Name: Z-0103-2027 UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10
Creator: AVID Medical, Inc.
Published: 2026-08-10
License: https://open.fda.gov/license/

AVID Medical, Inc. / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-0103-2027
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-10-07
Recalling firm: AVID Medical, Inc.
Product: UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;
Product code: LRO General Surgery Tray
Reason for recall: Product may be potentially contaminated with a lubricant used during the manufacturing process.
FDA root cause: Process change control
Action: On August 10, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, segregate, and quarantine all Avid kits identified in Attachment 1. 2. Add recall labels to affected Avid kits to ensure all users are aware of the actions to discard the impacted component. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. Please contact your Sales Representative if pre-printed labels are needed. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. - Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. -Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.
Quantity in commerce: 20
Distribution: US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Product codes and lots: Model/Item Number (Kit): WRNM058-10; UDI-DI: 10809160488898; Kit Lot Numbers: 1681989; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU2887;

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-09. View this recall on fda.gov (opens on fda.gov)