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Recall Observatory FDA recall evidence

Device product

Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MJSALINE7

Z-1435-2026

January 05, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98319
Status
Ongoing
Classification
Class II
Quantity
104,608 units
Official record key
device-enforcement:Z-1435-2026

Official wording

Reason: 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.

Code information: Model Number MJSALINE7 - UDI-DI: 00708820657052 (unit), 10708820657059 (case), All Lots

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.