FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medline Sterile Saline Wound Wash recalled for potential sterility failure
What this means
Medline Industries recalled its 7.1 FL OZ Sterile Saline Wound Wash because the manufacturer may not have properly sterilized the product to meet safety standards. This affects all lots of model MDSALINE7 distributed nationwide and in the Caribbean. No injuries have been reported.
- Stop using this product immediately if you have it.
- Check the bottle for model number MDSALINE7 or UDI-DI 10193489089356.
- Do not use the recalled saline on wounds or for irrigation.
- Contact Medline or your healthcare provider if you have questions about safe wound care alternatives.
The agency's original wording
Hazard
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Affected count
3,578,805 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1431-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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