Recall Z-1431-2026 ยท FRO Dressing, Wound, Drug
Medline Industries, LP
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
| Date | Feb 20, 2026 (initiated Jan 5, 2026) |
| Status | Open, Classified |
| Reason | 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 | 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 comple |
| Quantity | 3,578,805 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112666 | SALINE WOUND WASH Nanoplas, Inc., Apr 20, 2012 |