FDA Enforcement Class II Ongoing

Medline convenience kits: WT LAVH PACK DYNJ46609F

Recall: Z-2433-2026 · Reported June 24, 2026

Enforcement

Recall Number
Z-2433-2026
Event ID
98951
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Medline Industries, LP
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date
June 24, 2026
Initiation Date
April 27, 2026
Classification Date
June 12, 2026
Address
3 Lakes Dr, Northfield, IL, 60093-2753, United States

Description

Medline convenience kits: WT LAVH PACK DYNJ46609F

Reason

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Code Info

DYNJ46609F UDI-DI 10198459403989 lot 25JBS436

Distribution

US Nationwide distribution. OUS distribution pending.

Quantity

49,654 kits total