Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium C...
FDA Recall #Z-1431-2026 — Class II — January 5, 2026
Product Description
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,578,805 units
Distribution
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Code Information
MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated