FDAHealthJanuary 5, 2026
Medline Industries, LP — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 5, 2026
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
What's affected?
- Product
- 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
- Lot code
- s
Additional details
MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,578,805 units.
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