FDAClass II · Medical device · Recalled June 24, 2026

MEDLINE Medical Procedure Kits labeled as recall — Medline Industries, LP

Hazard: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.

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

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2485-2026
Brand: Medline Industries
Classification: Class II
Units affected: 72 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DYNJ37378A

Affected products

MEDLINE Medical Procedure Kits labeled as

Companies & origin

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

Identifying details (verbatim from the notice)

Product codes / lots: UDI/DI 10889942113583 (each), 40889942113584 (case); Lot Numbers: DYNJ37378A, DYNJ37378A, DYNJ37378A.
Distribution: Worldwide distribution - US Nationwide and the countries of AE, BB, BM, BS, CA, CY, GU, NL, PA, QA, SA, VI.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 98994
Recall initiated: May 4, 2026
FDA classified: June 17, 2026
FDA report date: June 24, 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 23, 2026 at 11:04 PM UTC.

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