Food, drugs, devices › Medline Industries, LP
Device recall: Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (21
FDA enforcement event 98319 is a device recall by Medline Industries, LP of Northfield, IL, initiated 5 Jan 2026 and classified Class II, with 5 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medline Industries, LP has 66 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medline Industries, LP, Northfield, IL.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1431-2026 | 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 | 3,578,805 units | Class II | Ongoing | 4 Mar 2026 |
| Z-1432-2026 | Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 | 1640 units | Class II | Ongoing | 4 Mar 2026 |
| Z-1433-2026 | Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1 | 10550 units (495 additional units 3/27/26) | Class II | Ongoing | 4 Mar 2026 |
| Z-1434-2026 | Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 | 8773 units (594 additional units 3/27/26) | Class II | Ongoing | 4 Mar 2026 |
| Z-1435-2026 | 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 | 104,608 units | Class II | Ongoing | 4 Mar 2026 |
Context
Other enforcement events for Medline Industries, LP
All 66 events for Medline Industries, LP
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.