Z-1431-2026 Class II Ongoing
FDA device recall Z-1431-2026 was initiated by Medline Industries, LP on January 5, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3,578,805 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,578,805 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Code Information
MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots