Recall Z-0450-2026 ยท OHD Gynecological Laparoscopic Kit
Medline Industries, LP
Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
| Date | Nov 13, 2025 (initiated Oct 10, 2025) |
| Status | Open, Classified |
| Reason | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment. |
| Root cause | Nonconforming Material/Component |
| Action | Safety notice was provided to customers on 10/10/2025. Follow-up "URGENT MEDICAL DEVICE RECALL" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail. Customers were instructed to 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 and destroy affected kits on hand. No products are to be returned to Medline. Please use the link and the information below to complete your response form. Please list the quantity of affected product you |
| Quantity | 96,406 total units |
| Distribution | International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.