Medline Sterile Saline Wound Wash — Class II medical device recall Z-1431-2026
Ongoing recall by Medline Industries, LP, reported 2026-03-04, distributed nationwide. Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured produc
| Recall number | Z-1431-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-01-05 |
| Classified | 2026-02-20 |
| Reported by FDA | 2026-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BM, BS, KY |
| Quantity | 3,578,805 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489089356, 20193489089353 |
| Model numbers | MDSALINE7 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1431-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.