FDAHealthFebruary 27, 2026
Medline Industries, LP — Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
⚠️ Unapproved design changes to the products outside of the 510(k) clearance.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 27, 2026
Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
What's affected?
- Product
- Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G
- Lot code
- 24ABS765
Additional details
DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 270,311 total.
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