Changeflow GovPing Healthcare Meijer Saline Wound Wash Recall - Sterility Issue
Urgent Enforcement Removed Final

Meijer Saline Wound Wash Recall - Sterility Issue

Favicon for changeflow.com FDA: Device Recalls Class II
Filed March 4th, 2026
Detected March 29th, 2026
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Summary

The FDA has initiated a Class II recall for Meijer STERILE saline wound wash due to a potential sterility issue. The manufacturer may not have met the minimum required sterility assurance level for sterile products. Distribution was nationwide in the US and to the Bahamas, Bermuda, and Cayman Islands.

What changed

Medline Industries, LP is recalling Meijer STERILE saline wound wash (Model Number MJSALINE7) due to a potential failure to meet minimum sterility assurance levels. This recall is classified as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of adverse health consequences is remote. The product was distributed nationwide in the US and internationally to the Bahamas, Bermuda, and Cayman Islands.

Companies that may have received this product should immediately review their inventory and quarantine any affected units. While the recall is ongoing, affected parties should follow Medline's instructions for product return or disposition. The FDA's classification suggests a low probability of adverse health consequences, but proper handling and removal of the product from circulation are critical to prevent any potential risks.

What to do next

  1. Review inventory for affected Meijer STERILE saline wound wash.
  2. Quarantine any identified affected units.
  3. Follow Medline's instructions for product return or disposition.

Source document (simplified)

Medline Industries, LP

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1435-2026 · 20260304 · Ongoing

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

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.

Distribution

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

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1435-2026

Who this affects

Applies to
Retailers Importers and exporters
Industry sector
4453 Retail Trade
Activity scope
Product Recalls
Threshold
Class II recall
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Topics
Medical Devices Pharmaceuticals

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