ClearanceBrief
Recall Z-0137-2026 ยท LRO General Surgery Tray

Medline Industries, LP

Medline Adult Anesthesia Set, REF DYNJ39985G

DateOct 10, 2025 (initiated Sep 10, 2025)
StatusOpen, Classified
ReasonSpecific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
Root causeProcess control
ActionMedline issue an UREGNE MEDICAL DEVICE NOTICE to its consignees on 9/10/2025 via email. 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. 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 for
Quantity950 units
DistributionUS Nationwide distribution in the states of MO.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K213481Medline General Surgery Tray
Medline Industries, Inc., May 24, 2022