ClearanceBrief
Recall Z-2440-2026 ยท LRO General Surgery Tray

Medline Industries, LP

Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1328A

DateJun 12, 2026 (initiated Apr 27, 2026)
StatusOpen, Classified
ReasonKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Root causeProcess control
ActionFirm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity49,654 kits total
DistributionUS Nationwide distribution. OUS distribution pending.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

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