FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medline Sterile Saline Wound Wash recalled for potential sterility failure
OTHERNationwide distribution
Stop using Medline Sterile Saline Wound Wash
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.
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.
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 Industries, LP recalls
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- FDA-Device2026-07-29Medline urology robotic procedure packs recalled for defective Bard Silastic Foley Catheters
- FDA-Device2026-07-29Medline medical convenience kits recalled for potential Bacillus contamination
- FDA-Device2026-07-29Medline convenience kits with Bard Silastic Foley Catheters recalled for surface contamination
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