FDA Enforcement
Class II
Ongoing
Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
Recall: Z-2435-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2435-2026
- 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: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K
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
DYNJ905154I UDI-DI 10198459549977 lots 26ABB308 26BBA671 CDS760053K UDI-DI 10195327182977 lot 25KBP010
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total