ClearanceBrief
Recall Z-2436-2026 ยท OJH Orthopedic Tray

Medline Industries, LP

Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B ACL PACK DYNJ67271A ALIF DYNJ904848L ANTERIOR CERVICAL DYNJ901355J ARTHROSCOPY DYNJ908193B ARTHROSCOPY PACK-LF DYNJ42963M DYNJ52268B ARTHROSCOPY SHOULDER DYNJ908684A BACK CDS-LF CDS983364G BACK PACK DYNJT4339 CDH SPINE PACK DYNJ

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

This recall record lists no 510(k) number.