Recall Z-3024-2026 ยท LRO General Surgery Tray
Medline Industries, LP
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOP
| 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 | 663 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
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |