Recall Z-3153-2026 ยท LRO General Surgery Tray
AVID Medical, Inc.
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
| Date | Sep 16, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| Reason | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. |
| Root cause | Nonconforming Material/Component |
| Action | On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Identify, Segregate, and Quarantine all impacted kits listed. 2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 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. If pre-printed label |
| Quantity | 240 kits |
| Distribution | Domestic: IL, NC, VA, WY; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.