Z-1889-2026 Class II Ongoing
FDA device recall Z-1889-2026 was initiated by Medline Industries, LP on February 27, 2026 and is designated Class II. Reason for recall: Unapproved design changes to the products outside of the 510(k) clearance. The recall status is ongoing. Affected quantity: 270,311 total.
Recall Details
- Product Type
- Devices
- Report Date
- April 29, 2026
- Initiation Date
- February 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270,311 total
Product Description
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J
Reason for Recall
Unapproved design changes to the products outside of the 510(k) clearance.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Code Information
DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895