Moderate riskFDA DeviceMar 4, 2026Class II

Medline Nail Kit (DYKM1528) recalled for sterile saline solution sterility issue

Medline has recalled specific lots of its Nail Kit (Model DYKM1528) because the sterile saline wound wash included in the kit may not meet required sterility standards. The saline solution could potentially be contaminated. No injuries have been reported so far.

From the FDA notice · Read the official notice ↗ · All Medline recalls

What to do

Check if you have a Nail Kit Model DYKM1528 with one of the affected lot numbers listed in the recall
Do not use the sterile saline wound wash from the kit if your lot number matches the recall
Contact Medline or your supplier for a replacement or refund
If you have already used the saline from an affected lot, monitor the wound area and contact your healthcare provider if you notice signs of infection

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Sold in: Nationwide
Made for: All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected: 8773 units (594 additional units 3/27/26)
Illnesses reported: None reported
Manufactured in: 3 Lakes Dr, N/A, Northfield, IL, United States
Classification: Class II
Recall number: Z-1434-2026

In the FDA's words

Description: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 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. 1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25BBO366; 2) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABI804; 3) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25ABF375; 4) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24JBL155; 5) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24IBG900; 6) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBT801; 7) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24FBC584; 8) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24DBB692; 9) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 24BBL239; 10) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23KBO692; 11) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23IBT788; 12) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23HBJ026; 13) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23EBK780; 14) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23DBL149; 15) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 23CBJ576 Additional Lot as of 3/27/26: 1) DYKM1528, UDI-DI: 10889942689927(each), 40889942689928(case), Lot Number: 25IBP134 Distribution: Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands. Affected quantity: 8773 units (594 additional units 3/27/26)
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.

5 products in this recall

Medline and Meijer saline wound wash recalled for sterility concerns

Medline reported that the manufacturer of its sterile saline wound wash may not have made the products to the required sterility assurance level. The recall covers five products: a saline wound wash sold under the Medline and Meijer names, plus several Medline convenience kits. No injuries have been reported, and the products were distributed across the US and to the Bahamas, Bermuda, and the Cayman Islands.

The agency lists each product separately. Check every one you might have.

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,WO…
Z-1431-2026 · 3,578,805 units
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Z-1432-2026 · 1640 units
Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number:…
Z-1433-2026 · 10550 units (495 additional units 3/27/26)
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 (this page)
Z-1434-2026 · 8773 units (594 additional units 3/27/26)
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 Num…
Z-1435-2026 · 104,608 units