Recall Z-2144-2026 ยท OES Cardiac Catheterization Kit
Medline Industries, LP
1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/SKU 60033123; 3. MTS,3 VALVE,KIT, Medline Kit Number/SKU 60050183; 4. MTS,LEFT HEART,KIT, Medline Kit Number/SKU 60080349; 5. MTS,3 VALVE,LEFT HEART,KIT, Medline Kit Number/SKU 60100338; 6. MTS LHK, Medline Kit Number/SKU 60101017; 7. DBD-MTS,3 VALVE,KIT, Medline Kit Number/SKU 60130506; 8. MTS
| 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 | 322460 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.