FDAClass II · Medical device · Recalled April 29, 2026

Medline Kits recall — Medline Industries, LP

Hazard: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-1840-2026
Brand: Medline Industries
Classification: Class II
Units affected: 75 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y

Affected products

Medline Kits

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: 1) CDS930027Y, UDI-DI: 10198459303128(each), 40198459303129(case), Lot Number: 25EBE671
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98599
Recall initiated: February 25, 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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