Routine
Notice
Added
Medline convenience kits recall, sterility concern, DYKM1528
FDA: Device Recalls Class II
Detected
March 29th, 2026
Summary
Medline convenience kits recall, sterility concern, DYKM1528
Source document (simplified)
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1434-2026 · 20260304 · Ongoing
Product
Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528
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.
Source: openFDA Enforcement API
Related changes
Source
Analysis generated by AI. Source diff and links are from the original.
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