FDA Enforcement
Class II
Ongoing
Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L
Recall: Z-2420-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2420-2026
- 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: BREAST-HERNIA-PORT CDS-LF CDS984853L
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 10198459293535 Lots 26AME511 26AMG737
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total