ClearanceBrief
Recall Z-2428-2026 ยท OJG Neurological Tray

Medline Industries, LP

Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK DYNJ9814630O NEURO CDS-LF CDS983383L NEURO PACK DYNJ59397Q DYNJT7315 NEURO PACK-LF DYNJ25097I NEURO VP SHUNT/VAGAL NERVE-RF DYNJ21925S PK NEURO SHUNT BUMC DYNJT6428 RR-NEURO DBS HEAD PACK-LF DYNJ0785736M VP SHUNT SYNJ10307B

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.