Medline Sterile Saline Wound Wash, Cleansing & Wound… recallZ-1431-2026 · Medline Industries, LP · initiated Jan 5, 2026

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. 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

Recall details

Recall number

Z-1431-2026

Status

Open, Classified

Initiated by the company

Jan 5, 2026

Posted by the FDA

Feb 20, 2026

Recalling firm

Medline Industries, LP

Quantity

3,578,805 units

Product code

FRO

FDA submissions

K112666

Distribution

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

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• MEDLINE MDSALINE7

  Medline Industries, Inc. · Dressing, wound, drug
  1 recall2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 98319).

• Z-1432-2026 · Open, Classified
  Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
• Z-1433-2026 · Open, Classified
  Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KI…
• Z-1434-2026 · Open, Classified
  Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
• Z-1435-2026 · Open, Classified
  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