FDA Enforcement
Class II
Ongoing
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Recall: Z-1889-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1889-2026
- 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 E P DRAPE PACK-LF DYNJ0373061J
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Code Info
DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Quantity
270,311 total