Recall Z-3020-2026 ยท OEZ Cardiovascular Procedure Kit
Medline Industries, LP
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BAS
| Date | Aug 26, 2026 (initiated Jul 10, 2026) |
| Status | Open, Classified |
| Reason | Kits contain a potentially contaminated component which were recalled by the manufacturer |
| Root cause | Process change control |
| Action | Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/1/2026 via USPS and email. The notice explained the issue, potential hazard, 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. 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. Even if you do not have any affected product in inventory, |
| Quantity | 263 kits |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.