Recall Z-2964-2026 ยท OKV Obstetrical Kit
AVID Medical, Inc.
Halyard LAVH PACK, Model/Catalog Number: USAR053-11
| Date | Aug 14, 2026 (initiated Jul 10, 2026) |
| Status | Open, Classified |
| Reason | A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the component was subjected to EO sterilization which is not in alignment with the manufacturer s recommendation. |
| Root cause | Process control |
| Action | Owens & Minor issued an URGENT: MEDICAL DEVICE FIELD CORRECTION notice to its consignees on 7/10/2026 via email. The notice explained the issue, potential risks to health, and requested the following: "ACTIONS TO TAKE: " DO NOT USE AND DISCARD the Clearify Visualization System (Component# 5303907) located in the convenience kit identified in Table 1 above. All other components in the kits may continue to be used. " Add warning labels to affected AVID 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 a |
| Quantity | 40 packs |
| Distribution | US Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.