Medline Recalls Over 3.5 Million Units of Sterile Saline Wound Wash Due to Sterility Concerns
Medline Industries, LP has issued a voluntary recall for all lots of its Sterile Saline Wound Wash after identifying that the product may not meet required sterility assurance levels.
What Happened
Medline Industries, LP has initiated a voluntary Class II recall of its Sterile Saline Wound Wash. The company identified that the manufacturer of the product may not have adhered to the minimum sterility assurance levels required for products labeled as sterile. This defect was identified during an ongoing quality review process.
Which Products Are Affected
The recall affects approximately 3,578,805 units of the following product:
- Product Name: Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride)
- Size: 7.1 FL OZ (210 mL)
- Model Number: MDSALINE7
- UDI-DI: 10193489089356 (individual unit); 20193489089353 (case)
- Affected Lots: All Lots
- Recall Number: Z-1431-2026
The products were distributed nationwide across the United States and internationally to the Bahamas, Bermuda, and the Cayman Islands.
What You Should Do
Consumers, healthcare facilities, and distributors should immediately stop using and distributing all lots of the Medline Sterile Saline Wound Wash (Model MDSALINE7). Medline notified customers of this recall via a formal letter initiated on January 5, 2026. For information regarding product returns or further guidance, consumers may contact Medline Industries, LP at their headquarters in Northfield, Illinois.
Why This Matters
The use of a wound irrigation product that fails to meet sterility standards can introduce contaminants into open wounds, potentially leading to infections or other adverse health complications for patients.
Source
Information provided by the FDA (Recall Event ID: 98319).
Source: FDA Official Notice