Recall Z-2146-2026 ยท OGR Ear, Nose, And Throat Surgical Tray
Medline Industries, LP
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
| Date | May 8, 2026 (initiated Mar 24, 2026) |
| Status | Open, Classified |
| Reason | Medline has identified the presence of particulate within the fluid path of the Manifolds. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. |
| Quantity | 0 kits |
| Distribution | US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.