Z-1892-2026 Class II Ongoing
FDA device recall Z-1892-2026 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 ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
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
DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556