Recall Z-0098-2027 ยท OEZ Cardiovascular Procedure Kit
AVID Medical, Inc.
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;
| Date | Oct 7, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| Reason | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 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 sho |
| Quantity | 6 |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.