Recall Z-1435-2026

Medline Industries, LP · initiated January 5, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

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

Codes / lots: Model Number MJSALINE7 - UDI-DI: 00708820657052 (unit), 10708820657059 (case), All Lots

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.

FDA-determined cause: Under Investigation by firm

Action taken

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/6/26 was sent to customers regarding Saline Wound Wash. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-267 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/5/26 was sent to customers regarding Meijer Saline Wound Wash item number 347792. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed on the enclosed response form. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please complete and return the enclosed response form listing the quantity of affected product you have in inventory. Even if you do not have any affected product in inventory, please complete and return the response form. 3. Your account will receive credit once the response form is submitted, if applicable. 4. If you are a distributor, or have resold or transferred this prod

Details

Recall number
Z-1435-2026
Initiated
January 5, 2026
Posted by FDA
February 20, 2026
Product code
FRO – Dressing, Wound, Drug
Quantity
104,608 units
Distribution
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Recalling firm
Medline Industries, LP, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1431-2026 Class IIMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9%…Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… 01/05/2026Open, Classified
Z-1432-2026 Class IIMedline Convenience Kits: 1) NAIL KIT, Model Number: POD14214Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… 01/05/2026Open, Classified
Z-1433-2026 Class IIMedline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK…Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… 01/05/2026Open, Classified
Z-1434-2026 Class IIMedline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured… 01/05/2026Open, Classified