FDA Enforcement
Class II
Ongoing
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
Recall: Z-2416-2026
·
Reported June 24, 2026
Enforcement
- Recall Number
- Z-2416-2026
- 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
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A
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
DYNJRA2119A UDI-DI 10198459194702 lot 25LBB738 DYNJRA1011A UDI-DI 10888277783614 lots 25KBB849 25LBB734
Distribution
US Nationwide distribution. OUS distribution pending.
Quantity
49,654 kits total