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 | The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea. |
| Product | Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A; 6) NEURO PACK, Catalog Number: DYNJ86656; 7) NEURO ACD, Catalog Number: DYNJ904549G |
| Quantity | 234 kits |
| Distribution | US Nationwide. |
| Initiated | 2026-08-10 |
| Classified | 2026-09-24 |
| Recall number | Z-3268-2026 |
| 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-3268-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99739/
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