Medical device recalls Moderate risk

Medline Industries, LP recalls Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013;…

Recall date
January 5, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1433-2026
FDA classification
Class II
Brand / firm
Medline Industries, LP
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.

Why it was recalled

Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1

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