ClearanceBrief
Recall Z-1693-2026 ยท LRO General Surgery Tray

Medline Industries, LP

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

DateMar 27, 2026 (initiated Feb 18, 2026)
StatusOpen, Classified
ReasonThere is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Root causeUnder Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 2/18/26 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. Upon completion of the below actions, please destroy 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 response f
Quantity420 units
DistributionUS Nationwide distribution in the state of MN.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.