FDA Enforcement
Class II
Ongoing
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Recall: Z-1888-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1888-2026
- Event ID
- 98601
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medline Industries, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 29, 2026
- Initiation Date
- February 27, 2026
- Classification Date
- April 17, 2026
- Address
- 3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States
Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPY PACK DYNJ45173D
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Code Info
DYNJ45173D UDI-DI 10889942485222 (EA) 40889942485223 (CS) LOT 24BBB811
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Quantity
270,311 total