FDA Enforcement
Class II
Ongoing
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Recall: Z-1892-2026
·
Reported April 29, 2026
Enforcement
- Recall Number
- Z-1892-2026
- 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 ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
Reason
Unapproved design changes to the products outside of the 510(k) clearance.
Code Info
DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Quantity
270,311 total