Recall Z-0358-2027 ยท LRO General Surgery Tray
AVID Medical, Inc.
Halyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
| Date | Nov 5, 2026 (initiated Sep 8, 2026) |
| Status | Open, Classified |
| Reason | Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack." |
| Root cause | Process control |
| Action | AVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. Consignees were instructed to segregate and quarantine product identified, to add the corrected shelf label to all affected kits in inventory, and if any of the affected units have been further distributed to notify those consignees. Additionally, consignees were requested to complete and return the provided Recall Response Form by GM-OMRA_RECALLS@owens-minor.com. If you have any questions, contact Manager, Regulatory Affairs at 470-280-4277. |
| Quantity | 17 kits |
| Distribution | US Nationwide distribution in the state of Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.