Class II — Medline Industries, LP
| Recalling firm | Medline Industries, LP |
|---|---|
| Registered facility | View this company's 31 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 | Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 |
| Quantity | 8773 units (594 additional units 3/27/26) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands. |
| Initiated | 2026-01-05 |
| Classified | 2026-02-20 |
| Recall number | Z-1434-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medline Industries, LP (Z-1434-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98319/
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