Recall Z-3137-2026 ยท LRO General Surgery Tray
Medline Industries, LP
Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008N
| Date | Sep 11, 2026 (initiated Jul 23, 2026) |
| Status | Open, Classified |
| Reason | The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a compromised pouch seal is not identified prior to use and the cannula is used, there is a potential risk of infection or other complications associated with the use of a non-sterile device, including hemolysis, foreign body reaction, thromboembolism, and/or organ dysfunction. |
| Root cause | Packaging process control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 7/23/25 was sent to customers. 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, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-121-FGX |
| Quantity | 135 units |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |