FDA Enforcement
Class II
Ongoing
Medline EBSI Kit EBSI1534
Recall: Z-2414-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2414-2026
- 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 EBSI Kit EBSI1534
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
UDI-DI 10653160350507 Lot 2025110490
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total