Z-1431-2026Class II

Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride)...

Name: Z-1431-2026 Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride)...
Creator: Medline Industries, LP
Published: 2026-01-05
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-01-05 / Open, Classified / root cause: sterility

FDA source

Medline Industries, LP began a recall of Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL)... on 2026-01-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1431-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-05
Posted: 2026-02-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: 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
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 3,578,805 units
Distribution: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Product codes and lots: MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1431-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1431-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1432-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1433-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1434-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20
Z-1435-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-03-04	2026-02-20

Product code FRO

K112666UnclassifiedSaline Wound WashNanoplas, Inc. / cleared 2012-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)