Recall Z-1433-2026— Medline Industries, LP

Name: FDA recall Z-1433-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-05

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-01-05. It names one FDA 510(k) clearance: K112666. Product: 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. Reason: 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..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-01-05
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K112666 — SALINE WOUND WASHNanoplas, Inc.·cleared 2012-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.