FDAClass II · Medical device · Recalled April 29, 2026

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P recall — Medline Industries, LP

Hazard: Unapproved design changes to the products outside of the 510(k) clearance.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1889-2026
Brand: Medline Industries
Classification: Class II
Units affected: 270,311 total
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

Affected products

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P

Companies & origin

Recalling firm location: Northfield, IL, United States
Firm address: 3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots: DYNJ0373061J UDI-DI 10889942396856 (EA) 40889942396857 (CS) LOT 24ABR895
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.
Firm notified the public via: Letter
FDA event ID: 98601
Recall initiated: February 27, 2026
FDA classified: April 17, 2026
FDA report date: April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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