FDA-Device2026-03-04Class IIPROCESSING DEFECT
Medline Nail Kit (DYKM1528) recalled for sterile saline solution sterility issue
What this means
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.
- 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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.
Affected count
8773 units (594 additional units 3/27/26)
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1434-2026More Medline recalls
- FDA-Device2026-09-09Medline Convenience Kits recalled for potential sterility breach in antiseptic applicators
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for contamination risk
- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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