FDA Enforcement
Class II
Ongoing
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Recall: Z-1336-2026
·
Reported February 18, 2026
Enforcement
- Recall Number
- Z-1336-2026
- Event ID
- 98284
- 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
- February 18, 2026
- Initiation Date
- December 24, 2025
- Classification Date
- February 9, 2026
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Medline medical convenience kits packaged as: MERCY CIRCUMCISION TRAY, Kit SKU CIT6135B
Reason
Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.
Code Info
UDI/DI 10653160990666, Lot Number 25EBC648
Distribution
US Nationwide distribution.
Quantity
168 units