Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (21

FDA device recall Z-1431-2026 · posted 2026-02-20 · Open, Classified

Recall details

Recalling firm

Medline Industries, LP

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.

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FRO

Quantity affected

3,578,805 units

Distribution

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

Date initiated

2026-01-05

Date posted

2026-02-20

Location

Northfield, IL

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