FDA DevicesClass II
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Sali...
Published: March 4, 2026Recall ID: Z-1431-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98319 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots |
| Postal code | 60093-2753 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 3,578,805 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260105 |
| Initial firm notification | Letter |
| Center classification date | 20260220 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.